Press Releases April 21, 2026 08:00 AM

Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Positive Phase 3 PEAK trial results in GIST presented at ASCO 2026, supporting regulatory progress and clinical pipeline expansion

By Priya Menon COGT

Cogent Biosciences announced the oral presentation of positive Phase 3 PEAK trial results combining bezuclastinib and sunitinib for advanced gastrointestinal stromal tumors (GIST) at ASCO 2026. The trial showed promising efficacy in patients previously treated with imatinib. The company has submitted a New Drug Application (NDA) under the FDA's RTOR program and plans to initiate a Phase 2 trial in first-line GIST patients with exon 9 mutations. This highlights Cogent's progress in developing precision therapies targeting KIT mutations.

Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
COGT

Key Points

  • Phase 3 PEAK trial data indicates improved outcomes for bezuclastinib + sunitinib vs sunitinib alone in advanced GIST after imatinib.
  • Submission of NDA via FDA's Real-Time Oncology Review program accelerates potential approval timeline.
  • Planned Phase 2 trial targeting first-line GIST patients with exon 9 mutations expands clinical development pipeline.

WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, May 29-June 2, 2026. The presentation will feature data from the positive trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Top line results were reported in November 2025, and the New Drug Application was submitted under the Real-Time Oncology Review (RTOR) program in March 2026.

Oral Presentation Details

Abstract Title: Primary Results of the Phase 3 Peak Study of bezuclastinib + sunitinib vs sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors (GIST)
Abstract Number for Publication: 11500
Presenter: Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School
Session Date and Time: May 30, 2026, 3:00 PM-6:00 PM CT (4:00 PM-7:00 PM ET)
Session Title: Oral Abstract Session - Sarcoma 
Location: South Building, Floor 1, Grand Ballroom, S100bc - McCormick Place Convention Center, Chicago, IL

Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

Contact:
Christi Waarich
Senior Director, Investor Relations
[email protected]
617-830-1653


Risks

  • Regulatory approval is not guaranteed despite positive phase 3 results and NDA submission, impacting biotech sector sentiment.
  • Clinical trial outcomes in subsequent studies may differ, affecting commercial viability and investor confidence.
  • Competition from other targeted therapies in oncology could limit market share for bezuclastinib combination.

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