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Last Updated: May 24, 2025

Investigational Drug Information for Taselisib


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What is the drug development status for Taselisib?

Taselisib is an investigational drug.

There have been 10 clinical trials for Taselisib. The most recent clinical trial was a Phase 3 trial, which was initiated on April 9th 2015.

The most common disease conditions in clinical trials are Breast Neoplasms, Lung Neoplasms, and Carcinoma. The leading clinical trial sponsors are National Cancer Institute (NCI), Genentech, Inc., and Southwest Oncology Group.

Recent Clinical Trials for Taselisib
TitleSponsorPhase
Trial of Taselisib in OvergrowthCentre Hospitalier Universitaire DijonPhase 1/Phase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)National Cancer Institute (NCI)Phase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)National Cancer Institute (NCI)Phase 2

See all Taselisib clinical trials

Clinical Trial Summary for Taselisib

Top disease conditions for Taselisib
Top clinical trial sponsors for Taselisib

See all Taselisib clinical trials

Taselisib: Development Update and Market Projections

Introduction

Taselisib, also known as GDC-0032, is a small-molecule inhibitor of the phosphoinositide 3-kinase (PI3K) pathway, specifically targeting the PI3K alpha isoform (p110α). Here, we will delve into the development updates and market projections for this drug candidate.

Development History

Taselisib was developed by Roche as a potential treatment for various cancers, particularly those with PI3K pathway alterations. The drug showed promise in preclinical studies, especially when combined with other therapies such as letrozole, an aromatase inhibitor used in the treatment of hormone receptor-positive (HR+) breast cancer[1].

Clinical Trials

Taselisib was evaluated in several clinical trials, including the Phase III "Sandpiper" study. However, in June 2018, Roche announced that it would not pursue further development of taselisib based on the top-line results of this study. Despite this, ongoing clinical trials continued for patients who were benefiting from the treatment[4].

Mechanism of Action

Taselisib inhibits the PI3K pathway, which is crucial in cell signaling and is often dysregulated in cancer. The PI3K pathway is involved in cell proliferation, survival, and metabolism. By inhibiting this pathway, taselisib can reduce tumor cell viability and increase apoptosis, particularly in combination with other therapies like letrozole and CDK4/6 inhibitors[1].

Combination Therapies

One of the notable aspects of taselisib is its efficacy in combination therapies. When used with letrozole, taselisib showed significant reductions in cellular viability and increased apoptosis in breast cancer cells, even in models of acquired letrozole resistance. Additionally, combining taselisib with a CDK4/6 inhibitor like palbociclib (PD-0332991) further enhanced its anti-tumor effects[1].

Market Projections

Although taselisib itself is no longer in active development, the broader market for PI3K inhibitors remains promising.

PI3K Inhibitors Market

The PI3K inhibitors market is expected to witness remarkable growth driven by advancements in cancer treatment and the increasing prevalence of oncological disorders. By 2034, this market is projected to expand significantly, with new and improved therapies entering the market. Key drivers include the launch of new pipeline agents, strategic collaborations, and the exploration of combination therapies with other targeted therapies like immune checkpoint inhibitors[5].

Challenges and Opportunities

Despite the promising outlook, the PI3K inhibitors market faces several challenges, including high development costs, complex regulatory requirements, and the emergence of resistance to PI3K inhibitors. However, these challenges also present opportunities for innovation and collaboration between industry, academia, and regulatory bodies[5].

Conclusion

While taselisib itself is no longer being developed, the insights gained from its clinical trials and preclinical studies contribute to the broader understanding and development of PI3K inhibitors. The market for these inhibitors is poised for significant growth, offering new treatment options for cancer patients.

Key Takeaways

  • Development Halt: Roche ceased further development of taselisib following the Phase III "Sandpiper" study results.
  • Mechanism of Action: Taselisib inhibits the PI3K alpha isoform, reducing tumor cell viability and increasing apoptosis.
  • Combination Therapies: Taselisib showed efficacy in combination with letrozole and CDK4/6 inhibitors.
  • Market Growth: The PI3K inhibitors market is expected to grow significantly by 2034, driven by new therapies and combination approaches.

FAQs

What is taselisib?

Taselisib, or GDC-0032, is a small-molecule inhibitor of the PI3K alpha isoform (p110α) developed by Roche.

Why was the development of taselisib halted?

The development of taselisib was halted following the top-line results of the Phase III "Sandpiper" study, which did not meet the expected outcomes.

What are the potential benefits of taselisib in cancer treatment?

Taselisib has shown potential in reducing tumor cell viability and increasing apoptosis, especially when used in combination with other therapies like letrozole and CDK4/6 inhibitors.

What is the current market outlook for PI3K inhibitors?

The PI3K inhibitors market is projected to grow significantly by 2034, driven by new therapies, combination approaches, and strategic collaborations.

What are the main challenges facing the PI3K inhibitors market?

The main challenges include high development costs, complex regulatory requirements, and the emergence of resistance to PI3K inhibitors.

Which companies are key players in the PI3K inhibitors market?

Key players include Roche, Iovance Biotherapeutics, Bristol-Myers Squibb, and others that are investing heavily in research and development of PI3K inhibitors[5].

Sources

  1. Genes and Cancer: "The PI3K inhibitor taselisib overcomes letrozole resistance in a breast cancer cell line engineered to express aromatase."
  2. Roots Analysis: "TIL Therapy Market Size, Share & Growth Forecast [2035]"
  3. GlobeNewswire: "Plaque Psoriasis Drug Forecast and Market Analysis to 2030"
  4. Wikipedia: "Taselisib"
  5. PR Newswire: "PI3K Inhibitors Market to Observe Stunning Growth During the Study Period 2020-2034"
Last updated: 2024-12-31

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