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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR TECENTRIQ


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Melanoma 11
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Condition MeSH

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

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

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

Sponsor Type for TECENTRIQ
Sponsor Trials
Other 284
Industry 251
NIH 67
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TECENTRIQ Market Analysis and Financial Projection

Last updated: February 8, 2026

What Is the Current Status of TECENTRIQ in Clinical Trials?

TECENTRIQ (atezolizumab) is an immunotherapy drug developed by Roche for multiple cancer indications. As of 2023, it has received regulatory approval in several countries for specific cancers, including non-small cell lung carcinoma (NSCLC), small cell lung cancer (SCLC), and urothelial carcinoma.

Key ongoing trials focus on expanding its indications and combination therapies:

  • Lung Cancer: Trials assess efficacy in first-line treatments, including combinations with chemotherapy (IMpower110) and targeted agents.
  • Breast Cancer: Studies for triple-negative breast cancer (TNBC), notably IMpassion130 and IMpassion131.
  • Other Cancers: Gliomas, colorectal, and liver cancers, with several phase 1 and 2 trials evaluating safety, dosage, and efficacy.

Notably, the IMpower trials have contributed to its regulatory approvals. Current trials span phase 1 to 3, with a focus on combination strategies and biomarker-driven patient selection.

How Does TECENTRIQ Market Presence Compare to Competitors?

Market Adoption and Regulatory Approvals

  • Regulatory Approvals: As of 2023, TECENTRIQ is approved in over 50 countries, including the U.S., EU, China, and Japan, for five main indications:

    • NSCLC
    • SCLC
    • Urothelial carcinoma
    • Small cell lung cancer with brain metastases
    • Triple-negative breast cancer (TNBC)
  • Market Share: It holds an estimated 11% of the global immune checkpoint inhibitor market, trailing Keytruda (pembrolizumab) and Opdivo (nivolumab). Its primary competitors in the PD-L1 inhibitor category include:

Drug Year of FDA Approval Main Indications Market Share (2023) Pricing (per dose)
Tecentriq 2016 Bladder, lung, breast, other cancers 11% ~$10,000 (USD) for a 1200 mg dose
Keytruda 2014 Melanoma, lung, head & neck, others 35% ~$12,500 (USD) for 200 mg dose
Opdivo 2015 Lung, kidney, melanoma, others 24% ~$15,000 (USD) for 240 mg dose

Revenue Performance

Roche reported TECENTRIQ sales of CHF 2.65 billion ($2.88 billion) in 2022, up from CHF 2.15 billion ($2.35 billion) in 2021. The growth reflects increased approvals and expanding indications, particularly in combination therapies.

Market Penetration Challenges

  • Competition from pembrolizumab (Keytruda) dominates in lung cancer.
  • Pricing pressures exist due to multiple high-cost immunotherapies.
  • Limited approval for some tumor types constrains market expansion.

What Are the Future Market Projections for TECENTRIQ?

Projected Growth (2023–2028)

Expected compound annual growth rate (CAGR) for TECENTRIQ revenues is approximately 12% driven by:

  • Expanded use in earlier treatment lines.
  • Off-label use for emerging indications based on ongoing trial results.
  • Superior combination regimens showing improved patient outcomes.

Market Size Estimates

By 2028, the global immune checkpoint inhibitor market could reach approximately $60 billion, with Roche's TECENTRIQ accounting for a significant segment due to ongoing approvals.

Key Drivers of Growth

  • Approval of TECENTRIQ in first-line NSCLC and breast cancer.
  • Acceptance in combination with chemotherapy and targeted therapies.
  • Advancements in biomarker-based patient selection.

Regulatory and Scientific Milestones Expected

  • FDA review of TECENTRIQ in combination with chemotherapy for earlier-stage NSCLC (expected in 2024).
  • New therapy approvals in China, especially for gastric and esophageal cancers.
  • Updated guidelines incorporating TECENTRIQ as a standard of care for select indications.

What Are the Challenges and Risks Facing TECENTRIQ?

  • Competition: Keytruda maintains market dominance with broader approvals.
  • Clinical Trial Failures: Some trials, like IMpassion131 in breast cancer, do not meet endpoints, affecting further development.
  • Pricing and reimbursement pressures in major markets.
  • Potential safety concerns, such as immune-related adverse events, require careful patient management.

Key Takeaways

  • TECENTRIQ is approved for multiple cancers, with ongoing trials targeting expansion.
  • It holds an 11% share of the immune checkpoint inhibitor market, trailing Keytruda and Opdivo.
  • Revenue growth remains strong but faces stiff competition and pricing challenges.
  • Future growth depends on regulatory approvals and successful trial outcomes, especially in lung and breast cancers.
  • The global market for immunotherapies is expanding at a CAGR of about 12%, with TECENTRIQ positioned as a key player.

FAQs

1. What are the main indications for TECENTRIQ today?
Approved for non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, and triple-negative breast cancer.

2. How does TECENTRIQ compare in efficacy with competitors?
Efficacy varies by indication. In trials like IMpower130, TECENTRIQ combined with chemotherapy demonstrated comparable outcomes to rivals like Keytruda, but head-to-head data is limited.

3. What upcoming trial results could influence TECENTRIQ’s market?
Results from phase 3 trials evaluating TECENTRIQ in previously untreated NSCLC and in combination with targeted agents in gastrointestinal cancers.

4. How does the pricing impact market penetration?
High per-dose costs (~$10,000–$15,000 USD) limit affordability, especially in emerging markets, potentially slowing penetration despite clinical efficacy.

5. What are the main risks for Roche regarding TECENTRIQ's future?
Failure to secure additional approvals, competition from other immunotherapies, and safety concerns could impair growth.


Sources:

[1] Roche Annual Report 2022.
[2] U.S. FDA Label for TECENTRIQ.
[3] IQVIA Sales Data 2023.
[4] ClinicalTrials.gov database.
[5] Market research reports from GlobalData and Grand View Research.

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