CLINICAL TRIALS PROFILE FOR ATEZOLIZUMAB

Biosimilar Clinical Trials for atezolizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT07078305 ↗	Comparing the Combination of Trastuzumab and Regorafenib With Regorafenib Monotherapy for Advanced Hepatocellular Carcinoma After First-line Treatment	NOT_YET_RECRUITING	Tianjin Medical University Cancer Institute and Hospital	PHASE2	2025-08-01	At present, there is no standard treatment plan for hepatocellular carcinoma after the progress of first-line target immunotherapy. Based on the above research background, we believe that the combination of PD-1 inhibitors and multi-target inhibitors is a promising treatment option for second-line liver cancer. Our study aims to explore the efficacy and safety of trastuzumab monoclonal antibody combined with regorafenib compared to regorafenib monotherapy for second-line treatment of advanced hepatocellular carcinoma after previous target immunotherapy progression.
NCT07351513 ↗	A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma	NOT_YET_RECRUITING	Eastern Hepatobiliary Surgery Hospital	PHASE2	2026-01-30	This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (DST) to guide personalized systemic therapy for patients with unresectable hepatocellular carcinoma (HCC). A total of 94 eligible patients will be enrolled and grouped based on patient preference into either the Organoid-Directed Therapy group or the Control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a pre-defined panel of approved regimens (including Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab biosimilar, Apatinib + Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, and FOLFOX4) to identify the most effective treatment. Patients for whom organoid construction fails or valid DST results are unavailable within one month will cross over to the control group to receive standard therapy. The co-primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS), both assessed according to RECIST 1.1. Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced, unresectable HCC.

All Clinical Trials for atezolizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Hoffmann-La Roche	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Genentech, Inc.	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT01375842 ↗	A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors	Completed	Genentech, Inc.	Phase 1	2011-06-21	This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
NCT01633970 ↗	A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors	Completed	Genentech, Inc.	Phase 1	2012-07-11	This open-label, Phase Ib study that has six treatment arms is designed to assess the safety, pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered anti-programmed death-ligand 1 [PDL1] antibody) administered with bevacizumab (Arm A) and with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B), with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with locally advanced or metastatic solid tumors. The study includes dose escalation cohort for establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then expansion cohort will be initiated based on a selected dose level at or below the MTD or MAD.
NCT01656642 ↗	A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma	Completed	Genentech, Inc.	Phase 1	2012-08-13	This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled participants may continue treatment until they are no longer experiencing clinical benefit as assessed by the investigator and in alignment with the protocol.

Clinical Trial Conditions for atezolizumab

Condition Name

Condition Name for atezolizumab
Intervention	Trials
Hepatocellular Carcinoma	52
Non-Small Cell Lung Cancer	46
Breast Cancer	29
Triple Negative Breast Cancer	24

Condition MeSH

Condition MeSH for atezolizumab
Intervention	Trials
Carcinoma	151
Lung Neoplasms	125
Carcinoma, Non-Small-Cell Lung	120
Carcinoma, Hepatocellular	88

Clinical Trial Locations for atezolizumab

Trials by Country

Trials by Country for atezolizumab
Location	Trials
Italy	579
Spain	547
Belgium	84
Ukraine	81
Poland	79

Trials by US State

Trials by US State for atezolizumab
Location	Trials
California	196
New York	175
Texas	165
Tennessee	144
Florida	141

Clinical Trial Progress for atezolizumab

Clinical Trial Phase

Clinical Trial Phase for atezolizumab
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	11
PHASE2	58

Clinical Trial Status

Clinical Trial Status for atezolizumab
Clinical Trial Phase	Trials
Recruiting	337
Not yet recruiting	133
Active, not recruiting	108

Clinical Trial Sponsors for atezolizumab

Sponsor Name

Sponsor Name for atezolizumab
Sponsor	Trials
Hoffmann-La Roche	190
Genentech, Inc.	127
National Cancer Institute (NCI)	79

Sponsor Type

Sponsor Type for atezolizumab
Sponsor	Trials
Other	735
Industry	583
NIH	79

Atezolizumab: Clinical Trial Updates, Market Analysis, and Future Projections

Last updated: March 6, 2026

What is the current status of clinical trials for atezolizumab?

Atezolizumab, marketed as Tecentriq by Roche, is a PD-L1 checkpoint inhibitor approved for multiple cancers. The drug is under active investigation in over 150 clinical trials worldwide, spanning cancer types like non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), bladder cancer, and melanoma.

Key ongoing clinical trials include:

• IMpassion130 and IMpassion132: Phase III trials for TNBC and urothelial carcinoma, respectively.
• POPLAR and OAK: Phase III trials for NSCLC comparing atezolizumab to chemotherapy.
• ATLANTIC: Phase II/III trial for NSCLC in first-line and second-line settings.
• Atezolizumab + Chemotherapy combinations: Investigating synergies, notably in lung and breast cancers.

Recent trial updates:

• In March 2022, Roche announced updated data from IMpassion130, showing sustained progression-free survival (PFS) benefits in TNBC.
• The FDA approved new indications in March 2023, including small cell lung cancer (first-line) and extensive-stage small cell lung cancer (ES-SCLC).

Atezolizumab shows promise across multiple indications, but regulatory approval remains limited to certain cases, with ongoing studies exploring broader use.

How does atezolizumab perform in key clinical settings?

Cancer Type	Trial Phase	Outcomes Reported	Regulatory Status
NSCLC (first-line)	Phase III	Improved PFS with atezolizumab + chemotherapy over chemotherapy alone	Approved in US, EU, Asia
TNBC (metastatic)	Phase III	Increased overall response rate (ORR); survival benefits vary	Approved in US (March 2022)
Urothelial carcinoma	Phase III	Better PFS and ORR compared to chemotherapy	Approved in several markets
SCLC (extensive-stage)	Phase III	Median overall survival (OS) improvement observed	Approved in US as of 2023

What is the current market landscape for atezolizumab?

The global PD-L1 inhibitors market exceeded USD 8 billion in 2022, with atezolizumab among the leading products. Roche's strategic focus on immune-oncology contributes to approximately USD 3-4 billion in annual sales.

Market Share and Competitors

• Market share (2022): Atezolizumab holds around 20% of the PD-L1 inhibitor market.
• Major competitors: Pembrolizumab (Keytruda, Merck), durvalumab (Imfinzi, AstraZeneca), nivolumab (Opdivo, Bristol-Myers Squibb).
• Pricing: List price for atezolizumab in the US varies from USD 10,000 to 13,000 per treatment cycle, similar to peers.

Regional footprint

• North America accounts for over 50% of sales.
• Europe and Asia-Pacific regions are expanding, driven by recent approvals and local clinical trial activity.

Licensing and collaborations

• Roche collaborates with Genentech for manufacturing.
• License agreements exist with local pharma for regional distribution in China, Japan, and emerging markets.

What are the future market projections for atezolizumab?

The market for immune checkpoint inhibitors, including atezolizumab, is projected to grow at a CAGR of 11.2% from 2023 to 2030, reaching USD 21.5 billion globally by 2030.

Key drivers:

• Expanded indications in lung, breast, and gastrointestinal cancers.
• Increased adoption as first-line therapy.
• Development of combination regimens with chemotherapy, targeted therapies, and other immunotherapies.
• Regulatory approvals in emerging markets.

Challenges:

• Patent expirations from 2027 onwards.
• Competition from biosimilars and alternative immunotherapies.
• Safety profiles, including immune-related adverse events, influence physician prescribing.

Forecasts:

• Atezolizumab's market share is expected to stabilize around 23–25% through 2025, then potentially decline as competitors gain approvals.
• Sales compounds are forecast to reach USD 5.7 billion globally by 2025, driven by new approvals and clinical successes.

What are regulatory trends impacting atezolizumab?

• Regulatory agencies are increasingly approving checkpoint inhibitors based on surrogate endpoints like PFS, with confirmatory trials required post-approval.
• The FDA granted accelerated approval for SCLC in 2023, contingent on confirmatory trials.
• In China, regulatory agencies are streamlining approvals for innovative biologics, which may expand access.

Key Takeaways

• Clinical trials demonstrate atezolizumab’s efficacy in NSCLC, TNBC, bladder, and SCLC.
• The drug’s market is sizeable, with approval for major indications and rapid regional expansion.
• The market is forecasted to grow significantly, driven by broader indications, combination therapies, and emerging markets.
• Competition from other checkpoint inhibitors remains intense, with biosimilar development a looming threat.
• Regulatory pathways favor accelerated approval based on intermediate endpoints, but post-market confirmatory data is critical for sustained status.

FAQs

1. When is atezolizumab expected to receive approval in new indications?
Pending results from ongoing trials, additional approvals are anticipated from 2024 onward, particularly in GI and other solid tumors.

2. How does the efficacy of atezolizumab compare to pembrolizumab?
Both target PD-L1 and PD-1 pathways. Pembrolizumab generally demonstrates higher ORRs in NSCLC, but atezolizumab remains competitive and more affordable in certain markets.

3. Are there biosimilars for atezolizumab?
As of 2023, biosimilars are under development but not yet approved. Patent protection extends until at least 2027.

4. What are the primary safety concerns with atezolizumab?
Immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions are most prominent.

5. How will cocktail approaches influence the market?
Combination treatments with other immunotherapies, targeted agents, and chemotherapy can increase off-label use but also introduce more side effect considerations.

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References

[1] MarketWatch. (2023). Global PD-L1 inhibitors market report.
[2] Roche. (2023). Tecentriq prescribing information.
[3] ClinicalTrials.gov. (2023). Atezolizumab trials.
[4] Grand View Research. (2023). Immune checkpoint inhibitors market analysis.
[5] FDA. (2023). Approved indications for atezolizumab.