CLINICAL TRIALS PROFILE FOR TECENTRIQ

All Clinical Trials for TECENTRIQ

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

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

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Trials by Country for TECENTRIQ
Location	Trials
Spain	231
Italy	230
Canada	91
Brazil	90
Australia	77

Trials by US State

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−

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
Phase 4	5
Phase 3	42
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for TECENTRIQ
Clinical Trial Phase	Trials
Recruiting	143
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	283
Industry	251
NIH	67

TECENTRIQ: Clinical Trials Update, Market Analysis, and Projections

Introduction to Tecentriq

Tecentriq, also known as atezolizumab, is an immune checkpoint inhibitor developed by Genentech, a member of the Roche Group. It works by modulating the immune system to recognize and eliminate cancer cells, making it a significant player in the cancer immunotherapy market.

Clinical Trials Update

SKYSCRAPER-01 Study

The SKYSCRAPER-01 study is a global Phase III, randomized, double-blinded trial evaluating the efficacy of tiragolumab plus Tecentriq versus Tecentriq alone as a first-line treatment for patients with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). The second interim analysis, conducted in February 2023, showed promising results, although the median overall survival estimates were not yet mature. The analysis indicated a median overall survival of 22.9 months in the tiragolumab plus Tecentriq arm and 16.7 months in the Tecentriq monotherapy arm, with a hazard ratio of 0.81[1].

SKYSCRAPER-06 Study

In contrast, the SKYSCRAPER-06 study, which evaluated the combination of tiragolumab plus Tecentriq and chemotherapy versus pembrolizumab and chemotherapy in non-squamous NSCLC, did not meet its primary endpoints of progression-free survival and overall survival. The trial showed reduced efficacy in both PFS and OS compared to the comparator arm, leading to the decision to halt the study[4].

Acclaim-3 Clinical Trial

Genprex's Acclaim-3 clinical trial is investigating the combination of Reqorsa® Gene Therapy and Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). The Phase 1 dose escalation portion has been completed, and the Safety Review Committee has approved the advancement to the Phase 2 expansion portion. Preliminary data suggest that the combination may provide clinical benefit, with one patient showing a partial remission[3].

Market Analysis

Current Market Size and Growth

The Tecentriq market was valued at USD 2.68 billion in 2023 and is projected to reach USD 7.86 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 16.6% from 2024 to 2031. This growth is driven by the increasing incidence of various cancers and the expanding use of immunotherapy as a therapeutic option[5].

Segment Analysis

The market for Tecentriq is segmented based on type (Atezolizumab Injection, Tecentriq Biosimilar, Tecentriq Combination Therapy) and application (Cancer Immunotherapy, Oncology, Lung Cancer, Bladder Cancer), as well as geographical regions. The drug's clearance for multiple cancer indications, including urothelial carcinoma, triple-negative breast cancer, and NSCLC, has significantly contributed to its market expansion[5].

Regional Market Trends

The global NSCLC market, in which Tecentriq plays a crucial role, is expected to rise to $26.8 billion by 2025, with a CAGR of 15.7%. The China NSCLC market is forecast to grow most rapidly, while the market share in the US and Japan is expected to decrease, and the market share in the 5EU is expected to increase[2].

Projections and Future Outlook

Immunotherapy Dominance

Immunotherapies, including Tecentriq, are projected to dominate the NSCLC market by 2025, accounting for approximately 65% of total sales. Keytruda, Opdivo, and Tecentriq are expected to be major contributors, with projected sales of $5.2 billion, $5.5 billion, and $2.8 billion, respectively[2].

New Indications and Combination Therapies

Ongoing clinical trials investigating Tecentriq's potential in additional malignancies and combination therapies are expected to further drive market expansion. The drug's effectiveness in treating various types of cancer and its role as an immune checkpoint inhibitor continue to support its market growth[5].

Competitive Landscape

Tecentriq competes with other immune checkpoint inhibitors like Keytruda and Opdivo. However, its unique profile and ongoing approvals for new indications and combination regimens are expected to maintain its strong market position[2][5].

Key Takeaways

• Clinical Trials: Tecentriq is being evaluated in various clinical trials, including the SKYSCRAPER-01 and Acclaim-3 studies, which show promising results in certain settings.
• Market Growth: The Tecentriq market is expected to grow significantly, driven by the increasing use of immunotherapy and the drug's effectiveness in treating multiple cancer types.
• Segment Analysis: The market is segmented by type and application, with a strong presence in cancer immunotherapy and oncology.
• Regional Trends: The global NSCLC market, particularly in China and the 5EU, is expected to contribute significantly to Tecentriq's market growth.
• Future Outlook: Ongoing clinical trials and new indications are expected to further drive the market expansion of Tecentriq.

FAQs

What is Tecentriq used for?

Tecentriq (atezolizumab) is used to treat various types of cancer, including non-small cell lung cancer (NSCLC), urothelial carcinoma, and triple-negative breast cancer, by modulating the immune system to recognize and eliminate cancer cells.

How is Tecentriq performing in clinical trials?

Tecentriq has shown promising results in some clinical trials, such as the SKYSCRAPER-01 study, but has not met primary endpoints in others, like the SKYSCRAPER-06 study. The Acclaim-3 trial suggests potential clinical benefit when combined with gene therapy.

What is the projected market size for Tecentriq by 2031?

The Tecentriq market is projected to reach USD 7.86 billion by 2031, growing at a CAGR of 16.6% from 2024 to 2031.

How does Tecentriq compare to other immune checkpoint inhibitors?

Tecentriq competes with Keytruda and Opdivo but maintains a strong market position due to its unique profile and ongoing approvals for new indications and combination therapies.

What are the key drivers of the Tecentriq market growth?

The key drivers include the increasing incidence of various cancers, the growing use of immunotherapy, and the ongoing approval of new indications and combination regimens.

Sources

1. Genentech Press Release: "Genentech Provides Update on Phase III SKYSCRAPER-01 Study Evaluating Tiragolumab Plus Tecentriq in NSCLC" - August 22, 2023.
2. GlobalData: "NSCLC Market - Global Drug Forecast & Market Analysis to 2025".
3. Genprex Press Release: "Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Portion of Acclaim-3 Clinical Trial of Reqorsa Gene Therapy in Combination with Tecentriq in Extensive Stage Small Cell Lung Cancer" - December 16, 2024.
4. Genentech Press Release: "Genentech Provides Update on Phase II/III SKYSCRAPER-06 Study Evaluating Tiragolumab Plus Tecentriq and Chemotherapy in NSCLC" - July 3, 2024.
5. Market Research Intellect: "Tecentriq Market Size and Projections" - December 2024.