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Last Updated: March 31, 2025

CLINICAL TRIALS PROFILE FOR ATEZOLIZUMAB


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All Clinical Trials for atezolizumab

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for atezolizumab

Condition Name

444129240051015202530354045Non-Small Cell Lung CancerHepatocellular CarcinomaBreast CancerUrothelial Carcinoma[disabled in preview]
Condition Name for atezolizumab
Intervention Trials
Non-Small Cell Lung Cancer 44
Hepatocellular Carcinoma 41
Breast Cancer 29
Urothelial Carcinoma 24
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Condition MeSH

151116110660020406080100120140160CarcinomaLung NeoplasmsCarcinoma, Non-Small-Cell LungBreast Neoplasms[disabled in preview]
Condition MeSH for atezolizumab
Intervention Trials
Carcinoma 151
Lung Neoplasms 116
Carcinoma, Non-Small-Cell Lung 110
Breast Neoplasms 66
[disabled in preview] 0
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Clinical Trial Locations for atezolizumab

Trials by Country

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Trials by Country for atezolizumab
Location Trials
Italy 547
Spain 502
China 87
Ukraine 81
Belgium 78
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Trials by US State

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Trials by US State for atezolizumab
Location Trials
California 187
New York 166
Texas 154
Tennessee 135
Florida 131
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Clinical Trial Progress for atezolizumab

Clinical Trial Phase

21.1%73.7%0050100150200250300Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for atezolizumab
Clinical Trial Phase Trials
Phase 4 7
Phase 3 88
Phase 2/Phase 3 15
[disabled in preview] 308
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Clinical Trial Status

48.9%22.7%18.5%9.9%0406080100120140160180200220240260280300RecruitingNot yet recruitingActive, not recruiting[disabled in preview]
Clinical Trial Status for atezolizumab
Clinical Trial Phase Trials
Recruiting 286
Not yet recruiting 133
Active, not recruiting 108
[disabled in preview] 58
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Clinical Trial Sponsors for atezolizumab

Sponsor Name

trials020406080100120140160180200Hoffmann-La RocheGenentech, Inc.National Cancer Institute (NCI)[disabled in preview]
Sponsor Name for atezolizumab
Sponsor Trials
Hoffmann-La Roche 183
Genentech, Inc. 116
National Cancer Institute (NCI) 75
[disabled in preview] 37
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Sponsor Type

51.7%42.2%6.1%00100200300400500600700OtherIndustryNIH[disabled in preview]
Sponsor Type for atezolizumab
Sponsor Trials
Other 639
Industry 522
NIH 75
[disabled in preview] 1
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Atezolizumab: Clinical Trials Update, Market Analysis, and Projections

Introduction to Atezolizumab

Atezolizumab, marketed under the brand name Tecentriq, is a groundbreaking immunotherapy drug developed by Roche. It works by targeting the PD-L1 protein on the surface of cancer cells, thereby blocking the interaction between PD-L1 and PD-1 on immune cells, which allows T-cells to recognize and destroy cancer cells[3].

Clinical Trials Update

Recent Trial Outcomes: SKYSCRAPER-01

A significant recent update comes from the phase 3 SKYSCRAPER-01 trial, which investigated the combination of tiragolumab and atezolizumab in patients with PD-L1–high non-small cell lung cancer (NSCLC). Although the second interim analysis showed promising results with a median overall survival (OS) of 22.9 months for the combination versus 16.7 months for atezolizumab alone, the final analysis failed to confirm these positive trends. The combination did not significantly improve OS compared to atezolizumab alone, and the safety profile remained consistent with previous reports[1].

Approval for Advanced Alveolar Soft Part Sarcoma

In a notable development, atezolizumab was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults and children 2 years and older with advanced alveolar soft part sarcoma (ASPS). This approval resulted from a phase 2 clinical trial led by the National Cancer Institute (NCI), which showed that about a third of the patients experienced tumor shrinkage, and most others had stable disease. The trial highlighted the drug's efficacy in a rare and understudied cancer type[4].

Market Analysis

Current Market Performance

As of 2023, the global sales of Tecentriq (atezolizumab) stood at USD 4,191.99 million, with a historical Compound Annual Growth Rate (CAGR) of 13% between 2020 and 2023[5].

Projected Market Growth

The atezolizumab market is expected to continue its upward trajectory. By 2025, the market is projected to reach over $5 billion, driven by increasing cancer incidence rates, advancements in immunotherapy, and growing investments in cancer research. The rising demand for effective treatment options, particularly in the context of personalized medicine, is a key driver of this growth[3].

Dominance in NSCLC Market

In the non-small cell lung cancer (NSCLC) market, atezolizumab is one of the leading immunotherapies. By 2025, immunotherapies, including atezolizumab, are expected to account for approximately 65% of the total NSCLC market, with sales projected to reach $17.5 billion. Atezolizumab, specifically, is anticipated to contribute $2.8 billion to this total[2].

Mechanism of Action and Therapeutic Applications

How Atezolizumab Works

Atezolizumab blocks the interaction between PD-L1 on cancer cells and PD-1 on immune cells, thereby reactivating T-cells to recognize and destroy cancer cells. This mechanism is crucial in enhancing the immune system's ability to combat cancer[3].

Therapeutic Applications

Atezolizumab is primarily used for treating various types of cancer, including NSCLC, bladder cancer, and triple-negative breast cancer. The recent FDA approval for advanced alveolar soft part sarcoma expands its therapeutic applications to rare cancer types as well[4].

Combination Therapies and Future Directions

Research into Combination Therapies

Studies are ongoing to evaluate the effectiveness of atezolizumab in combination with other treatments such as chemotherapy and targeted therapies. These combination therapies have shown promise in enhancing overall survival rates and improving patient outcomes, making them a focus for ongoing research[3].

Strategic Collaborations

Partnerships between pharmaceutical companies and research institutions are vital for advancing atezolizumab research. These collaborations aim to explore new applications, improve delivery methods, and enhance patient access to this therapy, further solidifying its place in oncology[3].

Regulatory Landscape and Market Competitiveness

Regulatory Approvals and Indications

The regulatory landscape for atezolizumab is evolving with new indications being approved for various cancers. Recent approvals have expanded its use in previously treated patients and in combination with other agents, broadening the potential patient population and increasing market competitiveness[3].

Support from Regulatory Bodies

Regulatory bodies are increasingly supportive of immunotherapies like atezolizumab, recognizing their potential to improve patient outcomes. Favorable health policies promoting innovative treatments are expected to continue driving the market growth for atezolizumab[3].

Market Barriers and Challenges

Patent Expirations and Generic Competition

While the atezolizumab market is growing, it faces challenges such as patent expirations of other blockbuster drugs in the NSCLC market. The uptake of generics, particularly for drugs like Tarceva and Alimta, is expected to negatively impact the growth of the NSCLC market, although atezolizumab's unique mechanism and ongoing research mitigate some of these risks[2].

Key Takeaways

  • Atezolizumab's market is projected to reach over $5 billion by 2025, driven by increasing cancer incidence and advancements in immunotherapy.
  • The drug has been approved for various cancers, including a recent approval for advanced alveolar soft part sarcoma.
  • Combination therapies with atezolizumab are being explored to enhance patient outcomes.
  • Strategic collaborations between pharmaceutical companies and research institutions are crucial for advancing atezolizumab research.
  • Regulatory bodies continue to support the use of atezolizumab, recognizing its potential to improve patient outcomes.

FAQs

What is the mechanism of action of atezolizumab?

Atezolizumab works by blocking the interaction between PD-L1 on cancer cells and PD-1 on immune cells, thereby reactivating T-cells to recognize and destroy cancer cells[3].

Which cancers is atezolizumab primarily used to treat?

Atezolizumab is primarily used for treating non-small cell lung cancer (NSCLC), bladder cancer, and triple-negative breast cancer, among other malignancies[3].

What is the recent update on the SKYSCRAPER-01 trial for atezolizumab?

The final analysis of the SKYSCRAPER-01 trial failed to confirm the positive trend for overall survival seen in the second interim analysis, showing that the combination of tiragolumab and atezolizumab did not significantly improve OS compared to atezolizumab alone[1].

How is the market for atezolizumab expected to grow by 2025?

The atezolizumab market is projected to reach over $5 billion by 2025, driven by increasing cancer incidence rates, advancements in immunotherapy, and growing investments in cancer research[3].

What are the potential side effects of atezolizumab?

Serious side effects of atezolizumab include anemia, diarrhea, rash, dizziness, hyperglycemia, and pain in the extremities, although no patients in the recent ASPS trial discontinued treatment due to side effects[4].

Sources

  1. Tiragolumab Plus Atezolizumab Fails to Meet OS End Point in PD-L1–High NSCLC. Onclive.
  2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. Drug Development.
  3. Atezolizumab Market Size And Projection - Market Research Intellect. Market Research Intellect.
  4. Clinical trial leads to atezolizumab approval for advanced alveolar soft part sarcoma. Medical Xpress.
  5. The Global Drug sales of Tecentriq (2020 - 2026, USD Millions). GlobalData.

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