- Bezuclastinib + sunitinib combination therapy reached median progression free survival (mPFS) of 19.4-months and 33% ORR in subset of advanced GIST patients with one prior treatment
- Encouraging long-term safety and tolerability with combination bezuclastinib and sunitinib therapy in Part 1
- PEAK Phase 3 guidance accelerated with enrollment completion now expected in 3Q 2024
- Company announces new advanced GIST clinical trial sponsored by the Sarcoma Alliance for Research through Collaboration (SARC) and in collaboration with
The Life Raft Group andDana-Farber Cancer Institute
“These data presented today reinforce our excitement that the combination of bezuclastinib and sunitinib has the potential to become a new standard of care for advanced GIST patients,” said
“We are also excited today to announce a collaboration with SARC,
“There is tremendous need for additional treatment options for GIST patients,” said
PEAK Trial Update
PEAK is a randomized, open-label, global, Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs sunitinib alone in GIST patients previously treated with imatinib. In the updated lead-in data being presented at ASCO, as of the cutoff date,
Safety Data
As of the data cutoff, the combination of bezuclastinib and sunitinib does not appear to add to the severity of adverse events known to be associated with sunitinib monotherapy and is well-tolerated. The majority of treatment-emergent adverse events (TEAEs) were low-grade and reversible. No additional serious adverse reactions or discontinuations due to TEAEs have been reported since the last presentation of data in
ASCO Poster Details
Title: Peak part 1 summary: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST)
Session Type and Title: Poster Session – Sarcoma
Session Date and Time:
The poster will be available in the Posters and Publications portion of the Cogent website at approximately
Phase 2 SARC Trial
The open label, single arm Phase 2 trial sponsored by SARC and in collaboration with
Enrollment continues in the Phase 3 registration-enabling PEAK study, which will include approximately 388 second-line, post imatinib GIST patients. Due to rapid enrollment, the Company now expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results still expected by the end of 2025. Cogent remains on-track to complete enrollment in APEX in patients with advanced systemic mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025 and complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025.
Cogent will participate in the
About
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the long-term safety and tolerability profile of the combination of bezuclastinib and sunitinib therapy, the potential for the combination of bezuclastinib and sunitinib to become a new standard of care for advanced GIST patients, the updated guidance that the Company now expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results still expected by the end of 2025, the expectation that PEAK will include approximately 388 second-line post imatinib GIST patients, the expectation to complete enrollment in APEX by the end of 2024 and to report top-line results mid-2025 and the expectation to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and to report top-line results by the end of 2025. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Contact:
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
Source:
2024 GlobeNewswire, Inc., source