Tecentriq (atezolizumab) - 8 indications

Scroll down for information on each indication:

• for the treatment of urothelial carcinoma; approved May 2016 - **withdrawn in November of 2022**
• for the treatment of metastatic non-small cell lung cancer (NSCLC); approved May 2016
• for the treatment of extensive-stage small cell lung cancer (SCLC); approved March 2019
• for the treatment of triple negative breast cancer; approved March 2019 - **withdrawn in September of 2021**
• for use in combination with chemotherapy (Abraxane and carboplatin) for the first-line treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; approved December 2019
• for the first-line treatment of metastatic NSCLC with high PD-L1 expression and no EGFR or ALK genomic tumor aberrations; approved May 2020
• for first-line treatment of unresectable or metastatic hepatocellular carcinoma in combination with Avastin (bevacizumab); approved May of 2020
• for use in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive melanoma; approved July 2020
• as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%, approved October of 2021

General Information

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody.

Tecentriq is specifically indicated for the following conditions:

• Locally Advanced or Metastatic Urothelial Carcinoma: **Indication withdrawn in November of 2022**
  • patients not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1
  • patients not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
• Metastatic Non-Small Cell Lung Cancer: 
  • in patients whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations
  • for first-line treatment in adults patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberration, in combination with bevacizumab, paclitaxel, and carboplatin
  • 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
  • for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy
  • as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%
• Triple-Negative Breast Cancer (TNBC): **Indication withdrawn in September of 2021**
  • in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 
• 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)
• Hepatocellular Carcinoma (HCC)
  • in combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy
• Melanoma
  • in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma

Tecentriq is supplied as a solution for intravenous administration. Scroll down for the recommended dosing/administration for each indication.

Mechanism of Action

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody. PD-L1 may be expressed on tumor cells and/or tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody­ dependent cellular cytotoxicity. 

Side Effects

Adverse effects associated with the use of Tecentriq in patients with locally advanced or metastatic urothelial carcinoma may include, but are not limited to, the following:

• fatigue
• decreased appetite
• nausea
• urinary tract infection
• pyrexia
• constipation

Adverse effects associated with the use of Tecentriq in patients with metastatic non-small cell lung cancer may include, but are not limited to, the following:

• fatigue
• decreased appetite
• dyspnea
• cough
• nausea
• musculoskeletal pain
• constipation

Adverse effects associated with the use of the Avastin/Tecentriq combination may include, but are not limited to, the following:

• bleeding in the gastrointestinal tract
• infections
• fever

Adverse effects associated with the use of Tecentriq in combination with chemotherapy for use on ES-SCLC may include, but are not limited to, the following:

• fatigue/asthenia
• nausea
• alopecia
• constipation
• diarrhea
• decreased appetite

Adverse effects associated with the use of Tecentriq in combination with paclitaxel protein-bound for triple negative breast cancer may include, but are not limited to, the following:

• alopecia
• peripheral neuropathies
• fatigue
• nausea
• diarrhea
• anemia
• constipation
• cough
• headache
• neutropenia
• vomiting
• decreased appetite

Adverse effects associated with the use of Tecentriq in combination with cobimetinib and vemurafenib in patients with melanoma may include, but are not limited to, the following:

• rash
• musculoskeletal pain
• fatigue
• hepatotoxicity
• pyrexia
• nausea
• pruritus
• edema
• stomatitis
• hypothyroidism
• photosensitivity reaction

Indication 1 - locally advanced or metastatic urothelial carcinoma

approved May 2016 ** This indication was withdrawn in November of 2022 after the confirmatory trial failed to show continued benefit**

Dosing/Administration

Select cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma for treatment with Tecentriq based on the PD-L1 expression on tumor infiltrating immune cells. The recommended dosage of Tectentriq is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. 

Clinical Trial Results

The FDA approval of Tecentriq was based on a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (objective response rate). The study also looked at the difference in effect based on “positive” versus “negative” expression of the PD-L1 protein on patients’ tumor-infiltrating immune cells. In all patients, 14.8 percent of experienced at least a partial shrinkage of their tumors, an effect that lasted from more than 2.1 to more than 13.8 months at the time of the response analysis. In patients who were classified as “positive” for PD-L1 expression, 26 percent experienced a tumor response, compared to 9.5 percent of patients who were classified as “negative” for PD-L1 expression.

Indication 2- metastatic non-small cell lung cancer (NSCLC)

approved May 2016

Dosing/Administration

Single Agent: Select patients with first-line metastatic non-small cell lung cancer for treatment with Tecentriq as a single agent based on the PD-L1 expression on tumor cells or on tumor infiltrating immune cells. The recommended dosage of Tectentriq is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. 

In Combination with Other Therapeutic Agents: 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy and bevacizumab when given on the same day. 

Clinical Trial Results

The FDA approval of Tecentriq for metastatic non-small cell lung cancer was based on results from the randomized Phase III OAK and Phase II POPLAR studies. OAK was a global, multicenter, open-label, randomized, controlled study which enrolled 1,225 patients who were randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or Tecentriq (1200 mg intravenous infusion) every three weeks. Results from OAK showed that Tecentriq helped subjects in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months). The study enrolled subjects regardless of their PD-L1 status and included both squamous and non-squamous disease types. POPLAR enrolled 287 subjects. The study showed Tecentriq doubled the likelihood of survival OS in subjects whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in subjects who had medium and high or any level of PD-L1 expression.

Indication 3 - extensive-stage small cell lung cancer (SCLC)

approved March 2019

Dosing/Administration

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy when given on the same day.

Clinical Trial Results

The FDA approval of Tecentriq for ES-SCLC was based on IMpower133, a Phase III, multicenter, double-blinded, randomized placebo- controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve people with ES-SCLC. The study enrolled 403 people who were randomized equally (1:1) to receive: Tecentriq in combination with carboplatin and etoposide (Arm A), or Placebo in combination with carboplatin and etoposide (Arm B, control arm). During the treatment-induction phase, patients received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed. The co-primary endpoints were progression-free survival (PFS) as determined by the investigator using RECIST v1.1 and OS in the ITT population. Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (OS=12.3 versus 10.3 months) in the ITT population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 versus 4.3 months).

Indication 4 - triple negative breast cancer 

approved March 2019 ** This indication was withdrawn in November of 2022 after the confirmatory trial failed to show continued benefit**

Dosing/Administration

Select patients with locally advanced or metastatic triple-negative breast cancer for treatment with Tecentriq in combination with paclitaxel protein-bound based on the PD-L1 expression on tumor-infiltrating immune cells. 

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity.

Administer Tecentriq prior to paclitaxel protein bound when given on the same day. For each 28 day cycle, paclitaxel protein-bound is administered at 100 mg/m2 on days 1, 8, and 15 until disease progression or unacceptable toxicity. Tecentriq and paclitaxel protein-bound may be discontinued for toxicity independently of each other. Do not substitute paclitaxel protein-bound with paclitaxel in combination with Tecentriq in clinical practice for metastatic TNBC outside of controlled trials.

Clinical Trial Results

IMpassion130 was a multicenter, international, double-blinded, placebo-controlled, randomized trial that included 902 unresectable locally advanced or metastatic triple-negative breast cancer patients who had not received prior chemotherapy for metastatic disease. Patients were randomized (1:1) to receive either Tecentriq (840 mg) or placebo intravenous infusions on Days 1 and 15 of every 28-day cycle, plus paclitaxel protein-bound (100 mg/m2) administered via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle. Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity. Results demonstrated that the combination of Tecentriq plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to treat and PD-L1 positive population. The treatment was most effective in the patient population with PD-L1 expression ≥ 1%: the median PFS for the Tecentriq plus chemo arm was 7.4 months versus 4.8 months for the placebo plus chemo arm. 

Indication 5 - in combination with chemotherapy (Abraxane and carboplatin) for the first-line treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations

approved December 2019

Dosing/Administration

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy and bevacizumab when given on the same day.

Clinical Trial Results

The FDA approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations was based on the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months) in the intention-to-treat wild-type (ITT-WT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months) in the ITT-WT population.

Indication 6 - first-line treatment of metastatic NSCLC with high PD-L1 expression and no EGFR or ALK genomic tumor aberrations

approved May 2020

Dosing/Administration

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy and bevacizumab when given on the same day.

Clinical Trial Results

The FDA approval for first line treatment for adults with PD-L1 expressing metastatic NSCLC with no EGFR or ALK genomic tumor aberrations was based on an interim analysis from the Phase III IMpower110 study, which showed Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]).

Indication 7 - first-line treatment of unresectable or metastatic hepatocellular carcinoma in combination with Avastin (bevacizumab)

approved May of 2020

Dosing/Administration

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Administer Tecentriq prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.

Clinical Trial Results

The FDA approval was based on the IMbrave150 global Phase III, multicenter, open-label study of 501 patients with unresectable or metastatic HCC who had not received prior systemic therapy. Patients were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Data demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% compared with sorafenib.

Indication 8 - in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of advanced BRAF V600 mutation–positive melanoma

approved July 2020

Dosing/Administration

Select patients with unresectable or metastatic melanoma for treatment with Tecentriq in combination with cobimetinib and vemurafenib after confirming the presence of a BRAF V600 mutation.

The recommended dose is 840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks until disease progression or unacceptable toxicity.

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.

Clinical Trial Results

The FDA approval was based on results from IMspire150, a multicenter, double-blind, placebo-controlled randomized phase III study. The study compared the efficacy and safety of atezolizumab plus cobimetinib and vemurafenib to the combination of placebo plus cobimetinib and vemurafenib in 514 patients with previously untreated BRAF V600 mutation–positive metastatic or unresectable locally advanced melanoma. The primary endpoint of the study was investigator-assessed progression-free survival. Eligible patients were assigned to receive 28-day cycles of either atezolizumab plus cobimetinib and vemurafenib or placebo plus cobimetinib and vemurafenib. In cycle 1, all patients received once-daily oral cobimetinib at 60 mg plus twice-daily oral vemurafenib at 960 mg for 21 days, followed by twice-daily vemurafenib at 720 mg or 960 mg for 7 days in the experimental group or control group, respectively. Patients in the experimental group received vemurafenib at 720 mg for days 1–28 of each subsequent cycle. The lower 720-mg dose of vemurafenib in the experimental group was a safety measure to mitigate the risk of overlapping toxicities, while ensuring an efficacious dose of the agent. Treatment was continued until investigator-determined disease progression, unacceptable toxicity, death, or patient/physician decision to withdraw, whichever occurred first. In the experimental arm, median progression-free survival was 15.1 months vs 10.6 months in the control arm.

Indication 9 - adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%

Approved October 2021

Dosing/Administration

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.

Clinical Trial Results

The approval is based on results from an interim analysis of the Phase III IMpower010 study that showed treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% in people with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC). Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq.