56% ORR in TKI-naïve patients, including 86% ORR by PPR criteria and 100% ORR in APEX patients treated at 100 mg BID with exposures consistent with go-forward dose
Nearly all patients achieved at least 50% improvement in key biomarkers of disease burden: serum tryptase reduction (94%), KIT D816V VAF reduction (93%), and bone marrow mast cell burden (97%)
Encouraging safety and tolerability profile with no related cognitive impairment or bleeding events reported
Cogent to host investor webcast today at
“Advanced systemic mastocytosis is a serious and life-threatening disease,” said
“We are pleased that today’s data reinforce bezuclastinib’s differentiated safety and tolerability profile while still delivering impactful clinical outcomes,” said
Patient Demographics
APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. As of the data cutoff date of
Safety Data
As of the data cutoff date of
Clinical Activity Data
As of the data cutoff date of
- 52% ORR (CR+CRh+PR) per mIWG-MRT-ECNM criteria, including 56% ORR for TKI-treatment-naïve patients
- 100% of patients treated with 100 mg BID achieved PR or better and all remain on study
- 150 mg QD optimized formulation dose selected for APEX Part 2 is expected to deliver patient exposures consistent with this cohort
- 150 mg QD optimized formulation dose selected for APEX Part 2 is expected to deliver patient exposures consistent with this cohort
- 100% of patients treated with 100 mg BID achieved PR or better and all remain on study
- 75% ORR (CR+PR) per pure pathological response (PPR) criteria, including 86% ORR for TKI-treatment-naïve patients
- Nearly all patients demonstrated a significant improvement in biomarkers associated with disease burden
- 94% of patients achieved ≥50% reduction in serum tryptase levels
- 100% of patients receiving ≥2 cycles achieved ≥50% reduction
- 53% of patients achieved reduction of serum tryptase below 20 ng/mL
- 93% of KITD816V-positive patients achieved ≥50% reduction in KIT D816V variant allele fraction (VAF)
- 97% of patients achieved a ≥50% reduction in bone marrow mast cell burden
- 79% achieved complete clearance of mast cell aggregates by central review
- 94% of patients achieved ≥50% reduction in serum tryptase levels
Bezuclastinib Clinical Development
Cogent continues to actively enroll Part 2 of the APEX trial which is expected to include approximately 65 AdvSM patients and is on track to complete enrollment by the end of 2024.
Cogent reported positive initial Part 1a data on
In Gastrointestinal Stromal Tumors (GIST), Cogent is actively enrolling patients in Part 2 of the Phase 3 registration-enabling PEAK trial and remains on track to complete enrollment by the end of 2024, with over 100 active sites globally.
Webcast Information and ASH Poster
Cogent will host a webcast today,
The APEX poster to be presented will be available in the Posters and Publications section of the Cogent website. Details of the poster are as follows.
- Poster Title: Safety and Efficacy of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM): Results From Part 1 of the Phase 2 Apex Trial
Date:Monday, December 11, 2023
Time:6:00 p.m. –8:00 p.m. PT /9:00 p.m. –11:00 p.m. ET
Presenter: Dr.Pankit Vachhani ,University of Alabama at Birmingham ,Birmingham, AL
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 potential of bezuclastinib to become a new treatment option patients with AdvSM; the expectation for the company to complete enrollment of approximately 65 patients in Part 2 of APEX by the end of 2024; that the 150 mg QD optimized formulation dose selected for APEX Part 2 is expected to deliver patient exposures consistent with the 100 mg BID Part 1 cohort; plans to initiate SUMMIT Part 2 in the first half of 2024; plans to present data from the completed SUMMIT Part 1 trial (1a and 1b) in the first quarter of 2024; and plans to complete enrollment in PEAK by the end of 2024 with over 100 active sites globally. 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:
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