What is mechanism of action?

mechanism of action is Programmed Death Receptor-1-directed Antibody Interactions [MoA]

Tecentriq

(Atezolizumab)

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Dosage & Administration

Administer TECENTRIQ intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

NSCLC

* In the adjuvant setting, administer TECENTRIQ following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks for up to 1 year. (

2.2 Recommended Dosage

The recommended dosages of TECENTRIQ are presented in Table 1. Administer TECENTRIQ as an intravenous infusion over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

The recommended intravenous dosages of TECENTRIQ in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with TECENTRIQ for the recommended dosage information, as appropriate.

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)
* In the metastatic setting, administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)
* When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Small Cell Lung Cancer

* Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to chemotherapy when given on the same day. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Hepatocellular Carcinoma

* Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Melanoma

* Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

ASPS

* Adults: Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)
* Pediatric patients 2 years of age and older: 15 mg/kg (up to a maximum of 1200 mg), every 3 weeks (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	* 840 mg every 2 weeks or * 1200 mg every 3 weeks or * 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

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Tecentriq Prescribing Information

Warnings and Precautions (

5.2 Infusion-Related Reactions

TECENTRIQ can cause severe or life-threatening infusion-related reactions, including anaphylaxis. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue TECENTRIQ based on the severity

[see Dosage and Administration (2.3)]

. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

In clinical studies enrolling 2616 patients with various cancers who received TECENTRIQ as a single-agent

[see Adverse Reactions (6.1)]

, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%). The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single-agent in patients with various cancers, in combination with other antineoplastic drugs in NSCLC and SCLC, and across the recommended dose range (840 mg Q2W to 1680 mg Q4W).

)

08/2025

Indications and Usage (

1.2 Small Cell Lung Cancer

TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.

)

10/2025

TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

Non-Small Cell Lung Cancer (NSCLC)

as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. (

1.1 Non-Small Cell Lung Cancer

TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA
[see Clinical Studies (14.1)]
non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
[see Dosage and Administration (2.1)].
TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
[see Dosage and Administration (2.1)].
TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.

14.1 Non-Small Cell Lung Cancer

Adjuvant Treatment of Stage II-IIIA NSCLC with PD-L1 Expression ≥ 1%

The efficacy of TECENTRIQ was evaluated in IMpower010 (NCT02486718), a multi-center, randomized, open-label trial for the adjuvant treatment of patients with NSCLC who had complete tumor resection and were eligible to receive cisplatin-based adjuvant chemotherapy. Eligible patients were required to have Stage IB (tumors ≥ 4 cm) – Stage IIIA NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system, 7th edition. Patients were excluded if they had a history of autoimmune disease; a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis; administration of a live, attenuated vaccine within 28 days prior to randomization; administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization.

A total of 1005 patients who had complete tumor resection and received cisplatin-based adjuvant chemotherapy were randomized (1:1) to receive TECENTRIQ 1200 mg intravenous infusion every 3 weeks for 16 cycles, unless disease recurrence or unacceptable toxicity occurred, or best supportive care (BSC). Randomization was stratified by sex, stage of disease, histology, and PD-L1 expression.

Tumor assessments were conducted at baseline of the randomization phase and every 4 months for the first year following Cycle 1, Day 1 and then every 6 months until year five, then annually thereafter.

The median age was 62 years (range: 26 to 84), and 67% of patients were male. The majority of patients were White (73%) and Asian (24%). Most patients were current or previous smokers (78%) and baseline Eastern Cooperative Oncology Group (ECOG) performance status in patients was 0 (55%) or 1 (44%). Overall, 12% of patients had Stage IB, 47% had Stage II and 41% had Stage IIIA disease. PD-L1 expression, defined as the percentage of tumor cells expressing PD-L1 as measured by the VENTANA PD-L1 (SP263) assay, was ≥ 1% in 53% of patients, <1% in 44% and unknown in 2.6%.

The primary efficacy outcome measure was disease-free survival (DFS) as assessed by the investigator. The primary efficacy analysis population (n = 476) was patients with Stage II – IIIA NSCLC with PD-L1 expression on ≥ 1% of tumor cells (PD-L1 ≥ 1% TC). DFS was defined as the time from the date of randomization to the date of occurrence of any of the following: first documented recurrence of disease, new primary NSCLC, or death due to any cause, whichever occurred first. A key secondary efficacy outcome measure was overall survival (OS) in the intent-to-treat population.

At the time of the interim DFS analysis, the study demonstrated a statistically significant improvement in DFS in the PD-L1 ≥ 1% TC, Stage II – IIIA patient population.

Efficacy results are presented in Table 24and Figure 1.

Table 24: Efficacy Results from IMpower010 in Patients with Stage II - IIIA NSCLC with PD-L1 expression ≥ 1% TC
	Arm A: TECENTRIQ N = 248	Arm B: Best Supportive Care N = 228
CI = Confidence interval, NE = Not estimable, NR = Not reached
Disease-Free Survival
Number of events (%)	88 (35)	105 (46)
Median, months	NR	35.3
(95% CI)	(36.1, NE)	(29.0, NE)
Hazard ratioStratified by stage, sex, and histology(95% CI)	0.66 (0.50, 0.88)
p-value	0.004

In a pre-specified secondary subgroup analysis of patients with PD-L1 TC ≥ 50% Stage II – IIIA NSCLC (n=229), the median DFS was not reached (95% CI: 42.3 months, NE) for patients in the TECENTRIQ arm and was 35.7 months (95% CI: 29.7, NE) for patients in the best supportive care arm, with a HR of 0.43 (95% CI: 0.27, 0.68). In an exploratory subgroup analysis of patients with PD-L1 TC 1-49% Stage II – IIIA NSCLC (n=247), the median DFS was 32.8 months (95% CI: 29.4, NE) for patients in the TECENTRIQ arm and 31.4 months (95% CI: 24.0, NE) for patients in the best supportive care arm, with a HR of 0.87 (95% CI: 0.60, 1.26).

Figure 1: Kaplan-Meier Plot of Disease-Free Survival in IMpower010 in Patients with Stage II – IIIA NSCLC with PD-L1 expression ≥ 1% TC

Referenced Image

At the time of the DFS interim analysis, 19% of patients in the PD-L1 ≥1% TC Stage II – IIIA patient population had died. An exploratory analysis of OS in this population resulted in a stratified HR of 0.77 (95% CI: 0.51, 1.17).

Figure 1

Metastatic Chemotherapy-Naïve NSCLC with High PD-L1 Expression

The efficacy of TECENTRIQ was evaluated in IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in patients with stage IV NSCLC whose tumors express PD-L1 (PD-L1 stained ≥ 1% of tumor cells [TC ≥ 1%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 1% of the tumor area [IC ≥ 1%]), who had received no prior chemotherapy for metastatic disease. PD-L1 tumor status was determined based on immunohistochemistry (IHC) testing using the VENTANA PD-L1 (SP142) Assay. The evaluation of efficacy is based on the subgroup of patients with high PD-L1 expression (TC ≥ 50% or IC ≥ 10%), excluding those with EGFR or ALK genomic tumor aberrations. The trial excluded patients with a history of autoimmune disease, administration of a live attenuated vaccine within 28 days prior to randomization, active or untreated CNS metastases, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization.

Randomization was stratified by sex, ECOG performance status, histology (non-squamous vs. squamous) and PD-L1 expression (TC ≥ 1% and any IC vs. TC < 1% and IC ≥ 1%). Patients were randomized (1:1) to receive one of the following treatment arms:

Arm A: TECENTRIQ 1200 mg every 3 weeks until disease progression or unacceptable toxicity
Arm B: Platinum-based chemotherapy

Arm B platinum-based chemotherapy regimens for non-squamous NSCLC consisted of cisplatin (75 mg/m²) and pemetrexed (500 mg/m²) OR carboplatin (AUC 6 mg/mL/min) and pemetrexed (500 mg/m²) on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles followed by pemetrexed (500 mg/m²) until disease progression or unacceptable toxicity.

Arm B platinum-based chemotherapy regimens for squamous NSCLC consisted of cisplatin (75 mg/m²) on Day 1 with gemcitabine (1250 mg/m²) on Days 1 and 8 of each 21-day cycle OR carboplatin (AUC 5 mg/mL/min) on Day 1 with gemcitabine (1000 mg/m²) on Days 1 and 8 of each 21-day cycle for a maximum of 4 or 6 cycles followed by best supportive care until disease progression or unacceptable toxicity.

Administration of TECENTRIQ was permitted beyond RECIST-defined disease progression. Tumor assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter. Tumor specimens were evaluated prospectively using the VENTANA PD-L1 (SP142) Assay at a central laboratory and the results were used to define subgroups for pre-specified analyses.

The major efficacy outcome measure was overall survival (OS) sequentially tested in the following subgroups of patients, excluding those with EGFR or ALK genomic tumor aberrations: TC ≥50% or IC ≥10%; TC ≥5% or IC ≥5%; and TC ≥1% or IC ≥1%.

Among the 205 chemotherapy-naïve patients with stage IV NSCLC with high PD-L1 expression (TC ≥ 50% or IC ≥ 10%) excluding those with EGFR or ALK genomic tumor aberrations, the median age was 65.0 years (range: 33 to 87), and 70% of patients were male. The majority of patients were White (82%) and Asian (17%). Baseline ECOG performance status was 0 (36%) or 1 (64%); 88% were current or previous smokers; and 76% of patients had non-squamous disease while 24% of patients had squamous disease.

The trial demonstrated a statistically significant improvement in OS for patients with high PD-L1 expression (TC ≥50% or IC ≥10%) at the time of the OS interim analysis. There was no statistically significant difference in OS for the other two PD-L1 subgroups (TC ≥5% or IC ≥5%; and TC ≥1% or IC ≥1%) at the interim or final analyses. Efficacy results for patients with NSCLC with high PD-L1 expression are presented in Table 25and Figure 2.

Table 25: Efficacy Results from IMpower110 in Patients with NSCLC with High PD-L1 Expression (TC ≥ 50% or IC ≥ 10%) and without EGFR or ALK Genomic Tumor Aberrations
	Arm A: TECENTRIQ N = 107	Arm B: Platinum-Based Chemotherapy N = 98
	CI=confidence interval; NE=not estimable
Overall SurvivalBased on OS interim analysis. The median survival follow-up time in patients was 15.7 months.
Deaths (%)	44 (41%)	57 (58%)
Median, months	20.2	13.1
(95% CI)	(16.5, NE)	(7.4, 16.5)
Hazard ratioStratified by sex and ECOG performance status(95% CI)	0.59 (0.40, 0.89)
p-valueBased on the stratified log-rank test compared to Arm A	0.0106Compared to the allocated alpha of 0.0413 (two-sided) for this interim analysis.

Figure 2: Kaplan-Meier Plot of Overall Survival in IMpower110 in Patients with NSCLC with High PD-L1 Expression (TC ≥ 50% or IC ≥ 10%) and without EGFR or ALK Genomic Tumor Aberrations

Referenced Image

Investigator-assessed PFS showed an HR of 0.63 (95% CI: 0.45, 0.88), with median PFS of 8.1 months (95% CI: 6.8, 11.0) in the TECENTRIQ arm and 5 months (95% CI: 4.2, 5.7) in the platinum-based chemotherapy arm. The investigator-assessed confirmed ORR was 38% (95% CI: 29%, 48%) in the TECENTRIQ arm and 29% (95% CI: 20%, 39%) in the platinum-based chemotherapy arm.

Figure 2

Metastatic Chemotherapy-Naive Non-Squamous NSCLC

IMpower150

The efficacy of TECENTRIQ with bevacizumab, paclitaxel, and carboplatin was evaluated in IMpower150 (NCT02366143), a multicenter, international, randomized (1:1:1), open-label trial in patients with metastatic non-squamous NSCLC. Patients with stage IV non-squamous NSCLC who had received no prior chemotherapy for metastatic disease but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene (tGE) status and ECOG performance status 0 or 1 were eligible. The trial excluded patients with a history of autoimmune disease, administration of a live attenuated vaccine within 28 days prior to randomization, active or untreated CNS metastases, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization, or clear tumor infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions as seen on imaging. Randomization was stratified by sex, presence of liver metastases, and PD-L1 expression status on tumor cells (TC) and tumor-infiltrating immune cells (IC) as follows: TC3 and any IC vs. TC0/1/2 and IC2/3 vs. TC0/1/2 and IC0/1. Patients were randomized to one of the following three treatment arms:

Arm A: TECENTRIQ 1200 mg, paclitaxel 175 mg/m²or 200 mg/m²and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles
Arm B: TECENTRIQ 1200 mg, bevacizumab 15 mg/kg, paclitaxel 175 mg/m²or 200 mg/m², and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles
Arm C: bevacizumab 15 mg/kg, paclitaxel 175 mg/m²or 200 mg/m², and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles

Patients who had not experienced disease progression following the completion or cessation of platinum-based chemotherapy, received:

Arm A: TECENTRIQ 1200 mg intravenously on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity
Arm B: TECENTRIQ 1200 mg and bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity
Arm C: bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Tumor assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter. Tumor specimens were evaluated prior to randomization for PD-L1 tumor expression using the VENTANA PD-L1 (SP142) assay at a central laboratory. Tumor tissue was collected at baseline for expression of tGE signature and evaluation was performed using a clinical trial assay in a central laboratory prior to the analysis of efficacy outcome measures.

Major efficacy outcome measures for comparison of Arms B and C were progression free survival (PFS) by RECIST v1.1 in the tGE-WT (patients with high expression of T-effector gene signature [tGE], excluding those with EGFR- and ALK-positive NSCLC [WT]) and in the ITT-WT subpopulations and overall survival (OS) in the ITT-WT subpopulation. Additional efficacy outcome measures for comparison of Arms B and C or Arms A and C were PFS and OS in the ITT population, OS in the tGE-WT subpopulation, and ORR/DoR in the tGE-WT and ITT-WT subpopulations.

A total of 1202 patients were enrolled across the three arms of whom 1045 were in the ITT-WT subpopulation and 447 were in the tGE-WT subpopulation. The demographic information is limited to the 800 patients enrolled in Arms B and C where efficacy has been demonstrated. The median age was 63 years (range: 31 to 90), and 60% of patients were male. The majority of patients were White (82%), 13% of patients were Asian, 10% were Hispanic, and 2% of patients were Black. Clinical sites in Asia (enrolling 13% of the study population) received paclitaxel at a dose of 175 mg/m²while the remaining 87% received paclitaxel at a dose of 200 mg/m². Approximately 14% of patients had liver metastases at baseline, and most patients were current or previous smokers (80%). Baseline ECOG performance status was 0 (43%) or 1 (57%). PD-L1 was TC3 and any IC in 12%, TC0/1/2 and IC2/3 in 13%, and TC0/1/2 and IC0/1 in 75%. The demographics for the 696 patients in the ITT-WT subpopulation were similar to the ITT population except for the absence of patients with EGFR- or ALK- positive NSCLC.

The trial demonstrated a statistically significant improvement in PFS between Arms B and C in both the tGE-WT and ITT-WT subpopulations, but did not demonstrate a significant difference for either subpopulation between Arms A and C based on the final PFS analyses. In the interim analysis of OS, a statistically significant improvement was observed for Arm B compared to Arm C, but not for Arm A compared to Arm C. Efficacy results for the ITT-WT subpopulation are presented in Table 26and Figure 3.

Table 26: Efficacy Results in ITT-WT Population in IMpower150
	Arm C: Bevacizumab, Paclitaxel and Carboplatin	Arm B: TECENTRIQ with Bevacizumab, Paclitaxel, and Carboplatin	Arm A: TECENTRIQ with Paclitaxel, and Carboplatin
	N = 337	N = 359	N = 349
CI=confidence interval
Overall Survival Based on OS interim analysis
Deaths (%)	197 (59%)	179 (50%)	179 (51%)
Median, months	14.7	19.2	19.4
(95% CI)	(13.3, 16.9)	(17.0, 23.8)	(15.7, 21.3)
Hazard ratioStratified by sex, presence of liver metastases, and PD-L1 expression status on TC and IC(95% CI)	---	0.78 (0.64, 0.96)	0.84 (0.72, 1.08)
p-valueBased on the stratified log-rank test compared to Arm C	---	0.016Compared to the allocated α=0.0174 (two sided) for this interim analysis	0.204Compared to the allocated α=0.0128 (two sided) for this interim analysis
Progression-Free Survival As determined by independent review facility (IRF) per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1)
Number of events (%)	247 (73%)	247 (69%)	245 (70%)
Median, months	7.0	8.5	6.7
(95% CI)	(6.3, 7.9)	(7.3, 9.7)	(5.6, 6.9)
Hazard ratio (95% CI)	---	0.71 (0.59, 0.85)	0.94 (0.79, 1.13)
p-value	---	0.0002Compared to the allocated α=0.006 (two sided) for the final PFS analysis	0.5219
Objective Response Rate
Number of responders (%)	142 (42%)	196 (55%)	150 (43%)
(95% CI)	(37, 48)	(49, 60)	(38, 48)
Complete Response	3 (1%)	14 (4%)	9 (3%)
Partial Response	139 (41%)	182 (51%)	141 (40%)
Duration of Response	n = 142	n = 196	n = 150
Median, months	6.5	10.8	9.5
(95% CI)	(5.6, 7.6)	(8.4, 13.9)	(7.0, 13.0)

Figure 3: Kaplan-Meier Curves for Overall Survival in ITT-WT Population in IMpower150

Referenced Image

Exploratory analyses showed that the subset of patients in the four drug regimen arm who were ADA positive by week 4 (30%) appeared to have similar efficacy (effect on overall survival) as compared to patients who tested negative for treatment-emergent ADA by week 4 (70%)

[see Clinical Pharmacology (12.6)]

. In an exploratory analysis, propensity score matching was conducted to compare ADA positive patients in the TECENTRIQ, bevacizumab, paclitaxel, and carboplatin arm with a matched population in the bevacizumab, paclitaxel, and carboplatin arm. Similarly ADA negative patients in the TECENTRIQ, bevacizumab, paclitaxel, and carboplatin arm were compared with a matched population in the bevacizumab, paclitaxel, and carboplatin arm. Propensity score matching factors were: baseline sum of longest tumor size (BSLD), baseline ECOG, baseline albumin, baseline LDH, sex, tobacco history, metastatic site, TC level, and IC level. The hazard ratio comparing the ADA-positive subgroup with its matched control was 0.69 (95% CI: 0.44, 1.07). The hazard ratio comparing the ADA-negative subgroup with its matched control was 0.64 (95% CI: 0.46, 0.90).

Figure 3

IMpower130

The efficacy of TECENTRIQ with paclitaxel protein-bound and carboplatin was evaluated in IMpower130 (NCT02367781), a multicenter, randomized (2:1), open-label trial in patients with stage IV non-squamous NSCLC. Patients with Stage IV non-squamous NSCLC who had received no prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor, if appropriate, were eligible. The trial excluded patients with history of autoimmune disease, administration of live attenuated vaccine within 28 days prior to randomization, administration of immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization, and active or untreated CNS metastases. Randomization was stratified by sex, presence of liver metastases, and PD-L1 tumor expression according to the VENTANA PD-L1 (SP142) assay as follows: TC3 and any IC vs. TC0/1/2 and IC2/3 vs. TC0/1/2 and IC0/1. Patients were randomized to one of the following treatment regimens:

TECENTRIQ 1200 mg on Day 1, paclitaxel protein-bound 100 mg/m²on Days 1, 8, and 15, and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles followed by TECENTRIQ 1200 mg once every 3 weeks until disease progression or unacceptable toxicity, or
Paclitaxel protein-bound 100 mg/m²on Days 1, 8 and 15 and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for a maximum of 4 or 6 cycles followed by best supportive care or pemetrexed.

Tumor assessments were conducted every 6 weeks for the first 48 weeks, then every 9 weeks thereafter. Major efficacy outcome measures were PFS by RECIST v1.1 and OS in the subpopulation of patients evaluated for and documented to have no EGFR or ALK genomic tumor aberrations (ITT-WT).

A total of 724 patients were enrolled; of these, 681 (94%) were in the ITT-WT population. The median age was 64 years (range: 18 to 86) and 59% were male. The majority of patients were white (90%), 2% of patients were Asian, 5% were Hispanic, and 4% were Black. Baseline ECOG performance status was 0 (41%) or 1 (58%). Most patients were current or previous smokers (90%). PD-L1 tumor expression was TC0/1/2 and IC0/1 in 73%; TC3 and any IC in 14%; and TC0/1/2 and IC2/3 in 13%.

Efficacy results for the ITT-WT population are presented in Table 27and Figure 4.

Table 27: Efficacy Results from IMpower130
	TECENTRIQ with Paclitaxel Protein-Bound and Carboplatin	Paclitaxel Protein-Bound and Carboplatin
CI=confidence interval
Overall SurvivalBased on OS interim analysis	n=453	n=228
Deaths (%)	228 (50%)	131 (57%)
Median, months	18.6	13.9
(95% CI)	(15.7, 21.1)	(12.0, 18.7)
Hazard ratioStratified by sex and PD-L1 tumor expression on tumor cells (TC) and tumor infiltrating cells (IC)(95% CI)	0.80 (0.64, 0.99)
p-valueBased on the stratified log-rank test	0.0384Compared to the allocated α=0.0428 (two sided) for this interim analysis
Progression-Free Survival As determined by independent review facility (IRF) per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1)	n=453	n=228
Number of events (%)	330 (73%)	177 (78%)
Median, months	7.2	6.5
(95% CI)	(6.7, 8.3)	(5.6, 7.4)
Hazard ratio (95% CI)	0.75 (0.63, 0.91)
p-value	0.0024Compared to the allocated α=0.006 (two sided) for the final PFS analysis
Overall Response Rate ^,Confirmed response	n=453	n=228
Number of responders (%)	207 (46%)	74 (32%)
(95% CI)	(41, 50)	(26, 39)
Complete Response	22 (5%)	2 (1%)
Partial Response	185 (41%)	72 (32%)
Duration of Response ^,	n=207	n=74
Median, months	10.8	7.8
(95% CI)	(9.0, 14.4)	(6.8, 10.9)

Figure 4: Kaplan-Meier Curves for Overall Survival in IMpower130

Referenced Image

Figure 4

Previously Treated Metastatic NSCLC

OAK

The efficacy of TECENTRIQ was evaluated in a multicenter, international, randomized (1:1), open-label study (OAK; NCT02008227) conducted in patients with locally advanced or metastatic NSCLC whose disease progressed during or following a platinum-containing regimen. Patients with a history of autoimmune disease, symptomatic or corticosteroid-dependent brain metastases, or requiring systemic immunosuppression within 2 weeks prior to enrollment were ineligible. Randomization was stratified by PD-L1 expression tumor-infiltrating immune cells (IC), the number of prior chemotherapy regimens (1 vs. 2), and histology (squamous vs. non-squamous).

Patients were randomized to receive TECENTRIQ 1200 mg intravenously every 3 weeks until unacceptable toxicity, radiographic progression, or clinical progression or docetaxel 75 mg/m²intravenously every 3 weeks until unacceptable toxicity or disease progression. Tumor assessments were conducted every 6 weeks for the first 36 weeks and every 9 weeks thereafter. Major efficacy outcome measure was overall survival (OS) in the first 850 randomized patients and OS in the subgroup of patients with PD-L1-expressing tumors (defined as ≥ 1% PD-L1 expression on tumor cells [TC] or immune cells [IC]). Additional efficacy outcome measures were OS in all randomized patients (n = 1225), OS in subgroups based on PD-L1 expression, overall response rate (ORR), and progression free survival as assessed by the investigator per RECIST v.1.1.

Among the first 850 randomized patients, the median age was 64 years (33 to 85 years) and 47% were ≥ 65 years old; 61% were male; 70% were White and 21% were Asian; 15% were current smokers and 67% were former smokers; and 37% had baseline ECOG performance status (PS) of 0 and 63% had a baseline ECOG PS of 1. Nearly all (94%) had metastatic disease, 74% had non-squamous histology, 75% had received only one prior platinum-based chemotherapy regimen, and 55% of patients had PD-L1-expressing tumors.

Efficacy results are presented in Table 28and Figure 5.

Table 28: Efficacy Results in OAK
	TECENTRIQ	Docetaxel
CI=confidence interval; NE=not estimable
Overall Survival in first 850 patients
Number of patients	N=425	N=425
Deaths (%)	271 (64%)	298 (70%)
Median, months	13.8	9.6
(95% CI)	(11.8, 15.7)	(8.6, 11.2)
Hazard ratioStratified by PD-L1 expression in tumor infiltrating immune cells, the number of prior chemotherapy regimens, and histology(95% CI)	0.74 (0.63, 0.87)
p-valueBased on the stratified log-rank test	0.0004Compared to the pre-specified allocated α of 0.03 for this analysis
Progression-Free Survival
Number of Patients	N=425	N=425
Events (%)	380 (89%)	375 (88%)
Progression (%)	332 (78%)	290 (68%)
Deaths (%)	48 (11%)	85 (20%)
Median, months	2.8	4.0
(95% CI)	(2.6, 3.0)	(3.3, 4.2)
Hazard ratio (95% CI)	0.95 (0.82, 1.10)
Overall Response Rate Per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1)
Number of Patients	N=425	N=425
ORR, n (%)	58 (14%)	57 (13%)
(95% CI)	(11%, 17%)	(10%, 17%)
Complete Response	6 (1%)	1 (0.2%)
Partial Response	52 (12%)	56 (13%)
Duration of Response	N=58	N=57
Median, months	16.3	6.2
(95% CI)	(10.0, NE)	(4.9, 7.6)
Overall Survival in all 1225 patients
Number of patients	N=613	N=612
Deaths (%)	384 (63%)	409 (67%)
Median, months	13.3	9.8
(95% CI)	(11.3, 14.9)	(8.9, 11.3)
Hazard ratio (95% CI)	0.79 (0.69, 0.91)
p-value	0.0013Compared to the allocated α of 0.0177 for this interim analysis based on 86% information using O'Brien-Fleming boundary

Figure 5: Kaplan-Meier Curves of Overall Survival in the First 850 Patients Randomized in OAK

Referenced Image

Tumor specimens were evaluated prospectively using the VENTANA PD-L1 (SP142) Assay at a central laboratory and the results were used to define the PD-L1 expression subgroups for pre-specified analyses. Of the 850 patients, 16% were classified as having high PD-L1 expression, defined as having PD-L1 expression on ≥ 50% of TC or ≥ 10% of IC. In an exploratory efficacy subgroup analysis of OS based on PD-L1 expression, the hazard ratio was 0.41 (95% CI: 0.27, 0.64) in the high PD-L1 expression subgroup and 0.82 (95% CI: 0.68, 0.98) in patients who did not have high PD-L1 expression.

Exploratory analyses showed that the subset of patients who were ADA positive by week 4 (21%) appeared to have less efficacy (effect on overall survival) as compared to patients who tested negative for treatment-emergent ADA by week 4 (79%)

[see Clinical Pharmacology (12.6)]

. ADA positive patients by week 4 appeared to have similar OS compared to docetaxel-treated patients. In an exploratory analysis, propensity score matching was conducted to compare ADA positive patients in the TECENTRIQ arm with a matched population in the docetaxel arm and ADA negative patients in the TECENTRIQ arm with a matched population in the docetaxel arm. Propensity score matching factors were: baseline sum of longest tumor size (BSLD), baseline ECOG, histology (squamous vs. non-squamous), baseline albumin, baseline LDH, gender, tobacco history, metastases status (advanced or local), metastatic site, TC level, and IC level. The hazard ratio comparing the ADA positive subgroup with its matched control was 0.89 (95% CI: 0.61, 1.3). The hazard ratio comparing the ADA negative subgroup with its matched control was 0.68 (95% CI: 0.55, 0.83).

Figure 5

)

for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. (
1.1 Non-Small Cell Lung Cancer
- TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA
  [see Clinical Studies (14.1)]
  non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  [see Dosage and Administration (2.1)].
- TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  [see Dosage and Administration (2.1)].
- TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
)
in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. (
1.1 Non-Small Cell Lung Cancer
- TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA
  [see Clinical Studies (14.1)]
  non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  [see Dosage and Administration (2.1)].
- TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  [see Dosage and Administration (2.1)].
- TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
)
in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations (
1.1 Non-Small Cell Lung Cancer
- TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA
  [see Clinical Studies (14.1)]
  non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  [see Dosage and Administration (2.1)].
- TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  [see Dosage and Administration (2.1)].
- TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
)
for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. (
1.1 Non-Small Cell Lung Cancer
- TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA
  [see Clinical Studies (14.1)]
  non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  [see Dosage and Administration (2.1)].
- TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  [see Dosage and Administration (2.1)].
- TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
)

Small Cell Lung Cancer (SCLC)

in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). (
1.2 Small Cell Lung Cancer
- TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
- TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.
)
in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. (
1.2 Small Cell Lung Cancer
- TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
- TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.
)

Hepatocellular Carcinoma (HCC)

in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. (
1.3 Hepatocellular Carcinoma
TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
)

Melanoma

in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. (
1.4 Melanoma
TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
[see Dosage and Administration (2.1)]
.
)

Alveolar Soft Part Sarcoma (ASPS)

for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS. (
1.5 Alveolar Soft Part Sarcoma
TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
)

Administer TECENTRIQ intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

NSCLC

In the adjuvant setting, administer TECENTRIQ following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks for up to 1 year. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

In the metastatic setting, administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Small Cell Lung Cancer

Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to chemotherapy when given on the same day. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Hepatocellular Carcinoma

Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Melanoma

Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

ASPS

Adults: Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Pediatric patients 2 years of age and older: 15 mg/kg (up to a maximum of 1200 mg), every 3 weeks (

2.2 Recommended Dosage

Table 1: Recommended Dosage of TECENTRIQ as a Single Agent
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
Metastatic NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
Adjuvant Treatment of NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Up to one year, unless there is disease recurrence or unacceptable toxicity
ASPS (adult)	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks	Until disease progression or unacceptable toxicity
ASPS (pediatric, 2 years of age and older)	15 mg/kg (up to a maximum 1200 mg) every 3 weeks	Until disease progression or unacceptable toxicity

Table 2: Recommended Dosage of TECENTRIQ in Combination with Other Therapeutic Agents
Indication	Recommended Dosage of TECENTRIQ	Duration of Therapy
NSCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
SCLC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to chemotherapy when given on the same day.
HCC	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.
Melanoma	840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily. Prior to initiating TECENTRIQ, patients should receive a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

)

Lactation

: Advise not to breastfeed. (

8.2 Lactation

Risk Summary

There is no information regarding the presence of atezolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise women not to breastfeed during treatment and for at least 5 months after the last dose.

Tecentriq

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