Cogent Biosciences Announces Updated Clinical Results from SUMMIT, Showcasing Powerful Symptomatic Improvement in NonAdvanced Systemic Mastocytosis Patients
Cogent Biosciences (NASDAQ: COGT) announced updated clinical results from the SUMMIT trial's Open Label Extension (OLE) evaluating bezuclastinib in nonadvanced systemic mastocytosis patients. The data showed significant improvements with 56% mean improvement in Total Symptom Score at 24 weeks, and 76% of patients achieving at least 50% reduction in symptoms.
The study demonstrated rapid pharmacodynamic response with 89% of patients showing >50% decrease in serum tryptase by week 4, and 95% achieving tryptase levels below 20 ng/ml by week 24. The safety profile was favorable with mostly low-grade, reversible adverse events.
SUMMIT Part 2 enrollment completed ahead of schedule with 179 patients enrolled, with top-line results expected in July 2025.
Cogent Biosciences (NASDAQ: COGT) ha annunciato risultati clinici aggiornati dalla fase di estensione in aperto (OLE) dello studio SUMMIT che valuta il bezuclastinib nei pazienti con mastocitosi sistemica non avanzata. I dati hanno mostrato miglioramenti significativi con un miglioramento medio del 56% nel punteggio totale dei sintomi a 24 settimane, e 76% dei pazienti che hanno raggiunto almeno una riduzione del 50% dei sintomi.
Lo studio ha dimostrato una rapida risposta farmacodinamica con il 89% dei pazienti che mostrano una diminuzione >50% della triptasi sierica entro la settimana 4, e il 95% che raggiungono livelli di triptasi al di sotto di 20 ng/ml entro la settimana 24. Il profilo di sicurezza è stato favorevole, con eventi avversi per lo più di grado basso e reversibili.
Il reclutamento per la Parte 2 dello studio SUMMIT è stato completato in anticipo, con 179 pazienti arruolati, e i risultati preliminari sono attesi per luglio 2025.
Cogent Biosciences (NASDAQ: COGT) anunció resultados clínicos actualizados de la extensión abierta (OLE) del ensayo SUMMIT que evalúa el bezuclastinib en pacientes con mastocitosis sistémica no avanzada. Los datos mostraron mejoras significativas con un mejoramiento medio del 56% en la puntuación total de síntomas a las 24 semanas, y el 76% de los pacientes logran al menos una reducción del 50% en los síntomas.
El estudio demostró una respuesta farmacodinámica rápida con el 89% de los pacientes mostrando una disminución >50% en la triptasa sérica para la semana 4, y el 95% alcanzando niveles de triptasa por debajo de 20 ng/ml para la semana 24. El perfil de seguridad fue favorable, con la mayoría de los eventos adversos de bajo grado y reversibles.
La inscripción para la Parte 2 del SUMMIT se completó antes de lo previsto, con 179 pacientes inscritos, y se esperan resultados preliminares en julio de 2025.
코겐트 바이오사이언스(COGT: NASDAQ)는 비진전성 전신 비만세포증 환자에서 베주클라스티닙을 평가하는 SUMMIT 시험의 개방형 연장(OLE)에서 업데이트된 임상 결과를 발표했습니다. 데이터는 24주차 총 증상 점수에서 평균 56% 개선과 76%의 환자가 증상을 50% 이상 감소시켰음을 보여주었습니다.
연구는 환자의 89%가 4주차에 혈청 트립타아제 수치가 50% 이상 감소하는 빠른 약리역학적 반응을 보였으며, 24주차에 95%가 트립타아제 수치를 20 ng/ml 이하로 유지했다고 보고했습니다. 안전성 프로파일은 대부분 경미하고 되돌릴 수 있는 부작용으로 우호적이었습니다.
SUMMIT 파트 2의 등록이 예정보다 일찍 완료되었으며, 179명의 환자가 등록되었습니다. 주요 결과는 2025년 7월에 발표될 예정입니다.
Cogent Biosciences (NASDAQ: COGT) a annoncé des résultats cliniques mis à jour de l'extension ouverte (OLE) de l'essai SUMMIT évaluant le bezuclastinib chez des patients atteints de mastocytose systémique non avancée. Les données ont montré des améliorations significatives avec une amélioration moyenne de 56% du score total des symptômes à 24 semaines, et 76% des patients atteignant au moins 50% de réduction des symptômes.
L'étude a montré une réponse pharmacodynamique rapide avec 89% des patients montrant une diminution >50% de la tryptase sérique d'ici la semaine 4, et 95% atteignant des niveaux de tryptase inférieurs à 20 ng/ml d'ici la semaine 24. Le profil de sécurité était favorable, avec principalement des événements indésirables de bas grade et réversibles.
L'inscription à la Partie 2 de l'étude SUMMIT a été achevée plus tôt que prévu, avec 179 patients inscrits, et les résultats préliminaires sont attendus pour juillet 2025.
Cogent Biosciences (NASDAQ: COGT) gab aktualisierte klinische Ergebnisse von der offenen Verlängerung (OLE) der SUMMIT-Studie bekannt, die Bezuclastinib bei Patienten mit nicht fortgeschrittener systemischer Mastocytose bewertet. Die Daten zeigt signifikante Verbesserungen mit einem mittleren Anstieg von 56% im Gesamtsymptomscores nach 24 Wochen, und 76% der Patienten erreichten mindestens eine 50%ige Reduzierung der Symptome.
Die Studie zeigte eine schnelle pharmakodynamische Reaktion mit 89% der Patienten, die bis Woche 4 einen >50%-igen Rückgang der SerumtrypTASE zeigten, und 95% erreichten bis Woche 24 Tryptasewerte unter 20 ng/ml. Das Sicherheitsprofil war günstig, mit hauptsächlich niedriggradigen, reversiblen unerwünschten Ereignissen.
Die Rekrutierung für Teil 2 der SUMMIT-Studie wurde vorzeitig abgeschlossen, mit 179 eingeschriebenen Patienten, und die ersten Ergebnisse werden im Juli 2025 erwartet.
- 56% mean improvement in Total Symptom Score (TSS) at 24 weeks
- 76% of patients achieved >50% reduction in symptoms
- 89% of patients showed >50% decrease in serum tryptase by week 4
- 95% of patients achieved target tryptase levels by week 24
- Early completion of enrollment with 179 patients
- 31% of patients reduced or discontinued supportive care medications
- Some patients experienced treatment-related adverse events including hair discoloration and transaminase elevations
- Two patients discontinued treatment due to adverse events
Insights
The updated SUMMIT trial results for bezuclastinib demonstrate remarkable efficacy in treating NonAdvanced Systemic Mastocytosis. The
The safety profile appears manageable, with mostly low-grade reversible adverse events and no treatment-related bleeding or cognitive issues. The early completion of SUMMIT Part 2 enrollment with 179 patients, significantly ahead of schedule, indicates strong investigator confidence and patient demand. This accelerated timeline, with top-line results expected in July 2025, positions bezuclastinib favorably in the competitive landscape for systemic mastocytosis treatments.
The accelerated enrollment and positive clinical data significantly enhance Cogent's market position. With 179 patients enrolled in SUMMIT Part 2 (six months ahead of schedule), the company has reduced development timeline risks and potentially accelerated time-to-market. The robust efficacy data, particularly the
The safety profile appears competitive, which could support broad market adoption. The fact that
SUMMIT Part 2 enrollment completed early; surpassing original enrollment target with 179 patients enrolled, top-line results now expected in July 2025
Cogent to host investor webcast today, Monday, December 9 at 8:00 a.m. ET
WALTHAM, Mass. and BOULDER, Colo., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced updated clinical results from the Open Label Extension (OLE) portion of SUMMIT, a clinical trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). The OLE data are being presented at the 66th American Society of Hematology (ASH 2024) Annual Meeting & Exposition taking place December 7-10, 2024 in San Diego, CA.
“The rapid, deep, and sustained symptomatic improvement reported by SUMMIT patients receiving bezuclastinib is very impressive,” said Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. “Coupled with its favorable tolerability profile, bezuclastinib has clear potential to establish itself as the best-in-class KIT inhibitor for systemic mastocytosis patients.”
“The SUMMIT data reported today are encouraging to thousands of NonAdvSM patients around the world who are waiting for a novel treatment that can rapidly and meaningfully improve a wide variety of symptoms that impact their daily lives,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We set out earlier this year to enroll our registration-directed SUMMIT Part 2 trial, and I’m excited to announce that based on the overwhelming demand from investigators and patients around the world, we’ve completed enrollment in the study with 179 patients more than six months ahead of schedule. Top-line results are now expected in July 2025, meaning we have dramatically accelerated our timeline as we aim to make bezuclastinib available to all NonAdvSM patients.”
Patient Demographics
SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM. In SUMMIT Part 1, patients received bezuclastinib or placebo for a 12-week period to determine the recommended dose for use in the pivotal portion of the trial, SUMMIT Part 2. Earlier this year, Cogent announced that the recommended go-forward dose was selected at once-daily 100 mg. After the initial 12-week period, all patients were given the opportunity to receive bezuclastinib in the SUMMIT Open Label Extension (OLE). The clinical results presented today focus on 27 patients in the OLE who were treated with the once-daily 100 mg dose of bezuclastinib. The median age of patients at study entry was 52 years (ranging from 36-76 years). One patient had received prior avapritinib.
Patient Reported Outcomes (PRO) Data
SUMMIT patients were evaluated for signs of clinical activity over 24 weeks using multiple PRO measures, including the Mastocytosis Symptom Severity Daily Diary (MS2D2) and the Mastocytosis Quality-of-Life (MC-QoL) scale. Updated clinical data presented today show:
56% mean improvement in Total Symptom Score (TSS) at 24 weeks76% of patients demonstrated >50% reduction from baseline in MS2D2 Total Symptom Score (TSS) with88% of patients exceeding30% reduction from baseline after 24 weeks49% mean improvement in MC-QoL Total Score at 24 weeks
At 24 weeks of treatment,
Pharmacodynamic Data
Bezuclastinib showed rapid, deep, and sustained reductions in serum tryptase over the course of 24 weeks of treatment including:
89% of patients had >50% decrease in serum tryptase levels by four weeks of treatment95% of patients with baseline tryptase ≥20ng/mL achieved <20ng/mL by week 2484% of patients with baseline serum tryptase >11.4ng/ml achieved <11.4ng/mL by week 24
Safety Data
As of the data cutoff, August 29, 2024, the median duration of bezuclastinib treatment was 56 weeks for patients in the active arm and 40 weeks for placebo patients who crossed over to the OLE. The majority of treatment emergent adverse events were low grade and reversible with no treatment-related bleeding or cognitive impairment events reported. The most common treatment related adverse events were hair discoloration and transaminase elevations. All patients experiencing elevated transaminases were asymptomatic and reversible: five patients resolved without any dose modifications and remain on study; two patients resolved with dose reduction and remain on study, one of whom re-escalated to original dose; and two patients resolved following discontinuation, one of whom was presented previously at ASH 2023. There were no other discontinuations due to adverse events.
SUMMIT Enrollment Update
Cogent also announced today that enrollment in the registration-directed SUMMIT Part 2 study is now complete. In the nine months between February and October 2024, 265 NonAdvSM patients were screened for SUMMIT Part 2 at 70 clinical sites, concentrated predominantly in the U.S. and Western Europe. More than
Webcast Information and ASH Poster
Cogent will host a webcast today, Monday, December 9, 2024, at 8:00 a.m. ET to discuss these updated SUMMIT clinical results. The live event will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days. The ASH poster is available to registered conference attendees and is also in the Posters and Publications section of Cogent’s website at www.cogentbio.com/research.
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, PI3Kα and KRAS. 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 company’s expectation to present top-line results from SUMMIT Part 2 in July 2025; the potential for bezuclastinib to establish itself as the best-in-class KIT inhibitor for systemic mastocytosis patients; and the company’s goal of making bezuclastinib available to all NonAdvSM patients. 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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