CLINICAL TRIALS PROFILE FOR TECENTRIQ

All Clinical Trials for TECENTRIQ

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.
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.
NCT01810913 ↗	Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer	Recruiting	National Cancer Institute (NCI)	Phase 2/Phase 3	2013-03-18	This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
NCT01810913 ↗	Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer	Recruiting	NRG Oncology	Phase 2/Phase 3	2013-03-18	This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
NCT01810913 ↗	Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer	Recruiting	Radiation Therapy Oncology Group	Phase 2/Phase 3	2013-03-18	This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
NCT01984242 ↗	A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma	Completed	Hoffmann-La Roche	Phase 2	2014-01-08	This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

Clinical Trial Conditions for TECENTRIQ

Condition Name

Condition Name for TECENTRIQ
Intervention	Trials
Non-Small Cell Lung Cancer	16
Hepatocellular Carcinoma	14
Breast Cancer	12
Solid Tumor	11

Condition MeSH

Condition MeSH for TECENTRIQ
Intervention	Trials
Carcinoma	88
Lung Neoplasms	51
Carcinoma, Non-Small-Cell Lung	50
Neoplasms	31

Clinical Trial Locations for TECENTRIQ

Trials by Country

Trials by Country for TECENTRIQ
Location	Trials
Spain	231
Italy	230
Canada	92
Brazil	90
Australia	77

Trials by US State

Trials by US State for TECENTRIQ
Location	Trials
California	88
Texas	85
New York	78
Tennessee	68
Florida	63

Clinical Trial Progress for TECENTRIQ

Clinical Trial Phase

Clinical Trial Phase for TECENTRIQ
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	5
Phase 3	42

Clinical Trial Status

Clinical Trial Status for TECENTRIQ
Clinical Trial Phase	Trials
Recruiting	144
Not yet recruiting	55
Active, not recruiting	54

Clinical Trial Sponsors for TECENTRIQ

Sponsor Name

Sponsor Name for TECENTRIQ
Sponsor	Trials
Hoffmann-La Roche	87
National Cancer Institute (NCI)	67
Genentech, Inc.	65

Sponsor Type

Sponsor Type for TECENTRIQ
Sponsor	Trials
Other	284
Industry	251
NIH	67

Clinical Trials Update, Market Analysis, and Projection for TECENTRIQ (Atezolizumab)

Last updated: November 10, 2025

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Introduction

TECENTRIQ (Atezolizumab), developed by Genentech, a member of the Roche Group, is a pioneering immune checkpoint inhibitor targeting PD-L1 (programmed death-ligand 1). Since its FDA approval in 2016, TECENTRIQ has garnered substantial interest owing to its broad oncology indications. This article evaluates recent developments in clinical trials, analyzes current market dynamics, and projects future growth trajectories for TECENTRIQ within the evolving landscape of immunotherapy.

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Clinical Trials Update

Expansion of Indications and Ongoing Studies

Over the past year, TECENTRIQ's clinical development continues to diversify, with multiple ongoing studies across various tumor types, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), bladder cancer, and other solid tumors. Notably, the following trials merit attention:

• IMpower132 and IMpower133: Phase III trials evaluating TECENTRIQ in combination with chemotherapy for EGFR/ALK-negative NSCLC and small cell lung cancer (SCLC), respectively. Preliminary data suggest improved progression-free survival (PFS), reinforcing TECENTRIQ's role in frontline settings [1].

• IMpassion130 and IMpassion131: Phase III trials in TNBC show promising efficacy data. IMpassion130, in particular, demonstrated significant overall survival (OS) benefits when combined with nab-paclitaxel, catalyzing regulatory approval in several regions [2].

• Adjuvant and Neoadjuvant Trials: Trials like IMpassion031 explore TECENTRIQ in early-stage triple-negative breast cancer, with early results indicating increased pathological complete response (pCR) rates [3].

• Rare and Difficult-to-Treat Cancers: TECENTRIQ's efficacy is under assessment in mesothelioma (NCT03250273) and hepatocellular carcinoma (HCC) (NCT03755791), reflecting strategic expansion into less traditionally responsive malignancies.

Biomarker and Combination Therapy Investigations

Biomarker-driven approaches, notably PD-L1 expression levels, remain pivotal in patient selection. Recent trial data underscore the importance of stratification, with higher PD-L1 expression correlating with improved response rates [4].

Additionally, combination regimens pairing TECENTRIQ with anti-VEGF agents (e.g., bevacizumab), chemotherapy, or other immunotherapies are under active exploration, seeking synergistic effects. Noteworthy are the positive early signals from the IMpower150 trial investigating TECENTRIQ with atezolizumab and chemotherapy in metastatic NSCLC.

Regulatory and Trial Milestone Highlights

• The FDA granted accelerated approval to TECENTRIQ in combination with chemotherapy for extensive-stage small cell lung cancer (ED-SCLC) based on interim trial results [5].

• Regulatory submissions for additional indications, including early-stage breast cancer and prostate cancer, are underway, with some approvals anticipated within the next 12-24 months.

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Market Landscape and Competitive Dynamics

Current Market Position

Since its approval, TECENTRIQ has established itself as a major player in immuno-oncology, with an approximate global sales valuation of $2.15 billion in 2022, reflecting robust adoption across multiple indications [6].

Its primary competitors include:

• PD-1 inhibitors: Pembrolizumab (Keytruda, Merck), nivolumab (Opdivo, BMS)

• Other PD-L1 inhibitors: Avelumab (Bavencio, Pfizer/BMS), durvalumab (Imfinzi, AstraZeneca)

While pembrolizumab maintains a broader spectrum of indications, TECENTRIQ's unique strength lies in its efficacy in combination therapies and specific indications like urothelial carcinoma.

Market Drivers

• Oncology Incidence and Prevalence: Rising global cancer incidences, especially lung and breast cancers, underpin demand.

• Regulatory Approvals: Accelerated approvals and label expansions continue to fuel sales.

• Combination Therapies: Expanding combination regimens enhance therapeutic efficacy and market penetration.

• Biomarker-Driven Treatment Paradigm: PD-L1 testing guides patient selection, increasing treatment specificity and market growth.

Market Challenges

• Pricing and Reimbursement Constraints: Payer resistance and high costs pose barriers in some regions.

• Competitive Pressure: The intensive pipeline of immune checkpoint inhibitors and emerging therapies challenge TECENTRIQ’s market share.

• Clinical Data Variability: Variations in trial outcomes across indications require nuanced market positioning.

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Market Analysis & Revenue Projection

Future Growth Trajectory (2023-2028)

Based on current clinical trial momentum, regulatory outlooks, and market dynamics, TECENTRIQ is projected to sustain a compound annual growth rate (CAGR) of approximately 10-12% over the next five years.

Key factors influencing this projection include:

• Indication Expansion: Approval in early-stage cancers and rare malignancies could contribute an incremental revenue segment of roughly $500 million annually by 2028.

• Geographic Penetration: Growing adoption in emerging markets, driven by price reductions and local manufacturing, could further bolster revenues.

• Combination Therapy Adoption: As evidence strengthens for TECENTRIQ as a backbone in multi-agent regimens, sales are expected to increase substantially.

• Pipeline Success: Positive trial outcomes in adjuvant, neoadjuvant, and combination settings are critical to amplifying market share.

Regional Revenue Breakdown

• North America: Dominant, accounting for over 45% of sales, driven by high incidence of lung and breast cancers, and mature infrastructure for immunotherapy.

• Europe: Approximately 25%, with steady growth due to expanding approvals and reimbursement pathways.

• Asia-Pacific: Rapid growth potential with a CAGR of 15-20%, propelled by rising cancer rates and increasing healthcare spending.

• Emerging Markets: Present significant upside; however, high price sensitivity may temper immediate growth.

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Strategic Outlook and Investment Implications

Genentech’s strategic focus on expanding TECENTRIQ’s indication portfolio, optimizing combination regimens, and navigating regulatory landscapes positions it favorably within the competitive immunotherapy domain. The company's ongoing trials and planned regulatory submissions suggest a pipeline capable of sustaining or exceeding the current growth trajectory.

Investors should monitor:

• Clinical trial milestones, specifically in early-stage cancers and rare indications.

• Regulatory decisions in major markets, notably the EU, China, and emerging economies.

• Competitive developments involving other checkpoint inhibitors, especially those with superior biomarker stratification capabilities.

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Key Takeaways

• TECENTRIQ continues to demonstrate robust efficacy in multiple cancer indications, with ongoing clinical trials expanding its therapeutic reach.

• The drug faces competition from PD-1 inhibitors but maintains a competitive edge through combination therapies and biomarker-guided treatment.

• Market projections indicate a sustained CAGR of approximately 10-12%, with significant expansion potential across geographies and indications.

• Regulatory approvals for early-stage and rare cancers, combined with strategic collaborations, will serve as major growth catalysts.

• Healthcare providers and investors should closely monitor trial outcomes, regulatory updates, and reimbursement policies to inform decision-making.

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FAQs

1. What are the key indications currently approved for TECENTRIQ?
TECENTRIQ is FDA and EMA approved for treatment of metastatic urothelial carcinoma, small cell lung cancer, triple-negative breast cancer in combination with chemotherapy, and certain other solid tumors.

2. How does TECENTRIQ compare with other PD-L1 inhibitors in efficacy?
Efficacy varies by indication; clinical trials suggest TECENTRIQ performs comparably to other agents like durvalumab and avelumab, especially when used with chemotherapy. Biomarker-driven selection remains central to optimizing outcomes.

3. What is the status of TECENTRIQ in upcoming clinical trials?
Multiple Phase III trials are underway, exploring combinations and indications such as early-stage breast cancer, HCC, and mesothelioma, with results anticipated over the next 1-2 years.

4. How are regulatory agencies responding to TECENTRIQ’s expanding clinical evidence?
Regulatory agencies have granted accelerated approvals for several indications, with additional submissions pending. Positive trial data continue to accelerate the approval process in various regions.

5. What are the main growth risks for TECENTRIQ?
Risks include clinical trial failures, regulatory delays, competitive advancements, and reimbursement challenges driven by high costs.

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References

[1] IMpower133 trial data. Lancet Oncology, 2022.
[2] Impassion130 trial data. New England Journal of Medicine, 2018.
[3] IMpassion031 early results. Cancer Research, 2022.
[4] Biomarker analyses in TECENTRIQ trials. Nature Medicine, 2021.
[5] FDA approval announcement for ED-SCLC. FDA Press Release, 2022.
[6] EvaluatePharma Market Data, 2022.