Cogent Biosciences Announces Phase 3 PEAK Trial in Patients with Gastrointestinal Stromal Tumors (GIST) Has Completed Enrollment and Advanced Past Interim Futility Analysis
Cogent Biosciences (Nasdaq: COGT) has announced significant progress in its clinical trials for bezuclastinib, a potential best-in-class KIT mutant inhibitor. The Phase 3 PEAK trial for gastrointestinal stromal tumors (GIST) has completed enrollment with 413 patients, exceeding the target. The trial has also advanced past the interim futility analysis with no modifications recommended. Additionally, the SUMMIT trial for nonadvanced systemic mastocytosis (NonAdvSM) is now expected to complete enrollment in Q1 2025, earlier than initially projected. Top-line results for both trials are anticipated in the second half of 2025. The company also announced the appointment of Darara Dibabu as Vice President of Marketing.
Cogent Biosciences (Nasdaq: COGT) ha annunciato progressi significativi nei suoi studi clinici per il bezuclastinib, un potenziale inibitore di classe leader per le mutazioni del KIT. Lo studio di Fase 3 PEAK trial per i tumori stromali gastrointestinali (GIST) ha completato l'arruolamento con 413 pazienti, superando l'obiettivo. Lo studio ha inoltre superato l'analisi intermedia di inutilità senza raccomandazioni di modifiche. Inoltre, il SUMMIT trial per la mastocitosi sistemica non avanzata (NonAdvSM) è ora previsto per completare l'arruolamento nel Q1 2025, prima del previsto inizialmente. I risultati preliminari di entrambi gli studi sono attesi per la seconda metà del 2025. L'azienda ha anche annunciato la nomina di Darara Dibabu come Vicepresidente Marketing.
Cogent Biosciences (Nasdaq: COGT) ha anunciado avances significativos en sus ensayos clínicos para el bezuclastinib, un potencial inhibidor líder de mutaciones del KIT. El ensayo de Fase 3 PEAK trial para tumores estromales gastrointestinales (GIST) ha completado su inscripción con 413 pacientes, superando el objetivo. Además, el ensayo ha avanzado más allá del análisis intermedio de futilidad sin recomendaciones de modificaciones. Adicionalmente, se espera que el SUMMIT trial para mastocitosis sistémica no avanzada (NonAdvSM) complete su inscripción en Q1 2025, antes de lo previsto inicialmente. Los resultados preliminares de ambos ensayos se anticipan para la segunda mitad de 2025. La compañía también anunció el nombramiento de Darara Dibabu como Vicepresidente de Marketing.
Cogent Biosciences (Nasdaq: COGT)는 KIT 변이 억제제인 bezuclastinib의 임상 시험에서 중요한 진전을 발표했습니다. 위장관간 질환 스트로마종(GIST)에 대한 3상 PEAK trial의 등록이 413명의 환자로 완료되어 목표를 초과했습니다. 이 시험은 또한 중간 비효율 분석을 통과하여 수정 권고가 없었습니다. 게다가 비전이 있는 전신 비판막증(nonadvanced systemic mastocytosis, NonAdvSM)에 대한 SUMMIT trial의 등록은 이제 2025년 1분기에 완료될 것으로 예상되며, 처음 예측한 것보다 빠릅니다. 두 시험의 최종 결과는 2025년 하반기에 예상됩니다. 회사는 또한 Darara Dibabu를 마케팅 부사장으로 임명했다고 발표했습니다.
Cogent Biosciences (Nasdaq: COGT) a annoncé des progrès significatifs dans ses essais cliniques pour le bezuclastinib, un inhibiteur potentiel de référence des mutations KIT. L'essai de Phase 3 PEAK trial pour les tumeurs stromales gastro-intestinales (GIST) a complété son inscription avec 413 patients, dépassant l'objectif. L'essai a également franchi l'analyse intermédiaire de futilité sans recommandation de modifications. De plus, l'essai SUMMIT pour la mastocytose systémique non avancée (NonAdvSM) devrait désormais compléter son inscription au Q1 2025, plus tôt que prévu initialement. Les résultats préliminaires des deux essais sont attendus dans la deuxième moitié de 2025. La société a également annoncé la nomination de Darara Dibabu en tant que vice-président du marketing.
Cogent Biosciences (Nasdaq: COGT) hat bedeutende Fortschritte in seinen klinischen Studien zu Bezuclastinib, einem potenziellen Spitzeninhibitor für KIT-Mutationen, bekannt gegeben. Die Phase-3-Studie PEAK trial für gastrointestinalen Stromatumoren (GIST) hat die Einschreibung mit 413 Patienten abgeschlossen und damit das Ziel überschritten. Die Studie hat zudem die interimistische Nichtigkeitsanalyse bestanden, ohne dass Änderungen empfohlen wurden. Darüber hinaus wird erwartet, dass die SUMMIT trial für nicht fortgeschrittene systemische Mastocytose (NonAdvSM) die Einschreibung im Q1 2025 abschließen wird, früher als ursprünglich prognostiziert. Die Ergebnisse beider Studien werden in der zweiten Hälfte von 2025 erwartet. Das Unternehmen gab auch die Ernennung von Darara Dibabu zum Marketing-Vizepräsidenten bekannt.
- PEAK Phase 3 trial completed enrollment with 413 patients, exceeding the target
- PEAK trial advanced past interim futility analysis with no changes recommended
- SUMMIT trial enrollment expected to complete in Q1 2025, three months ahead of schedule
- Appointment of experienced industry professional Darara Dibabu as VP of Marketing
- None.
The completion of enrollment in the Phase 3 PEAK trial for bezuclastinib in GIST patients is a significant milestone for Cogent Biosciences. With 413 patients enrolled, exceeding the target, the study's statistical power is likely enhanced. The positive outcome of the interim futility analysis is encouraging, suggesting the drug's potential efficacy.
The acceleration of the SUMMIT trial in NonAdvSM, now expected to complete enrollment in Q1 2025, indicates strong patient interest and potentially faster time-to-market for bezuclastinib in this indication. These developments position Cogent well for potential dual regulatory submissions by late 2025 or early 2026, assuming positive trial outcomes.
While these updates are promising, investors should note that final results are still pending and success in Phase 3 trials is never guaranteed. The company's focus on precision therapies for genetically defined diseases aligns with current trends in oncology drug development.
Cogent's clinical trial progress could have significant financial implications. The accelerated enrollment in both PEAK and SUMMIT trials may lead to earlier-than-expected data readouts, potentially catalyzing stock movement. If successful, bezuclastinib could address substantial markets in GIST and NonAdvSM.
The appointment of Darara Dibabu as VP of Marketing signals preparation for potential commercialization. His experience with successful oncology drug launches could be valuable for bezuclastinib's market entry strategy.
Investors should consider the burn rate and cash position, as Phase 3 trials are expensive. While not mentioned in the release, funding through to data readouts will be crucial. Positive trial results could open doors for partnerships or licensing deals, potentially boosting Cogent's valuation. However, the biotech sector remains high-risk and trial failures could significantly impact the stock price.
413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025
PEAK interim futility analysis completed with no changes to study
Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025; top-line results expected 2H 2025
WALTHAM, Mass. and BOULDER, Colo., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided several updates from the company’s ongoing registration-directed clinical trials of its potential best-in-class KIT mutant inhibitor, bezuclastinib.
Patient enrollment is now complete in Cogent’s Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumors (GIST). Based on strong global patient interest, a total of 413 patients were enrolled in the study. In addition, Cogent recently completed a pre-planned interim futility analysis, and the Independent Data Monitoring Committee (IDMC) recommended continuing the PEAK study without modification. This pre-specified analysis was based on an assessment of progression-free survival (PFS) as determined by independent central review and did not include the option for early stopping due to efficacy.
Separately, based on significant patient interest in the ongoing SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM), Cogent also announced today that it expects to complete enrollment in this study during Q1 2025, approximately three months earlier than originally projected.
“We are excited to announce these important updates to the PEAK and SUMMIT studies today,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Strong continued interest from patients around the world to participate in our bezuclastinib trials has allowed us to accelerate development and surpass our original enrollment timelines. Completing enrollment in our Phase 3 PEAK trial of bezuclastinib and sunitinib for second-line GIST patients several months ahead of schedule represents a significant milestone for the program and we are extremely grateful to the patients, families, caregivers, advocacy groups and clinical investigators for their participation in, and support of, the PEAK trial.”
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. The primary endpoint of the trial is median progression free survival (mPFS). PEAK is a registration study intended to support a New Drug Application (NDA) in GIST.
SUMMIT is a randomized, blinded, global, registration-directed clinical trial evaluating bezuclastinib vs. placebo in NonAdvSM patients. The primary endpoint of the trial is mean improvement in patient symptoms measured at 24 weeks. SUMMIT is intended to be a registrational study designed to support a New Drug Application (NDA) in NonAdvSM.
Appointment of Darara Dibabu as Vice President of Marketing
In addition to the updates to PEAK and SUMMIT trials, Cogent announced today that Mr. Dibabu has joined Cogent as the VP of Marketing. Mr. Dibabu has 25 years of experience in the biopharmaceutical industry, most recently as the Global Brand Lead of TUKYSA at Pfizer and SeaGen, where he led the global launch and marketing strategy of the product for metastatic breast cancer patients. Previously, he served in various roles of increasing responsibility at Seagen, Bayer and Merck. Mr. Dibabu holds a bachelor's degree in Biology from the University of Southern California. In connection with Mr. Dibabu joining the company, he was granted an “inducement” equity award in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The award was approved by the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, as an inducement material to Mr. Dibabu’s employment. The award consists of nonqualified options to purchase 100,000 shares of Cogent common stock with a 10-year term, at an exercise price of
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 to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Kα. 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.
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 expectation to report top-line results from the PEAK trial by the end of 2025, the expectation to complete enrollment in SUMMIT Part 2 in Q1 2025, three months earlier than originally projected, and to report top-line results in the second half of 2025, the potential for bezuclastinib to be a best-in-class KIT mutant inhibitor, the expectation for PEAK to support an NDA in GIST and the intention for SUMMIT to be a registrational study designed to support an NDA in NonAdvSM. 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:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
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