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BioXcel Therapeutics Announces Positive Full Data from Phase 2 Trial of BXCL701 in Rare, Aggressive Form of Prostate Cancer; to be Presented at 2023 ASCO Genitourinary Cancers Symposium
BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrated composite response rate of 25% in patients with metastatic SCNC-variant castration-resistant prostate
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrated composite response rate of 25% in patients with metastatic SCNC-variant castration-resistant prostate cancer Company plans to initiate randomized trial evaluating BXCL701 plus pembrolizumab versus BXCL701 monotherapy NEW HAVEN, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced full data from its Phase 2a trial of BXCL701, the Company's investigational, oral innate immune activator, in combination with KEYTRUDA® (pembrolizumab) in small cell neuroendocrine (SCNC) variant metastatic castration-resistant prostate cancer (mCRPC) patients after at least one prior line of chemotherapy for locally advanced or metastatic prostate cancer. Results will be presented in a rapid abstract presentation and a poster presentation at the 2023 American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) Symposium on February 16, 2023. “These data support the further study of BXCL701 plus pembrolizumab in a Phase 2b trial for the potential treatment of small cell neuroendocrine prostate cancer,” said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Associate Professor of Medicine at the University of California San Francisco (UCSF). “Against a challenging treatment landscape for neuroendocrine prostate cancer after first-line chemotherapy with no FDA-approved therapies and increasing incidence of disease following androgen signaling inhibition, the durability of responses observed is particularly encouraging for physicians and patients who have exhausted all therapeutic options. I look forward to further clinical studies evaluating BXCL701 in this high-risk disease setting.” KEY SCNC FINDINGS In the evaluable patient cohort (n = 28), 7 (25%) patients achieved a composite response, the primary endpoint of the trial.In patients with RECIST 1.1-defined measurable disease (n = 25), partial response (PR) was observed in 5 (20%) patients (4 confirmed PR, 1 unconfirmed PR). The disease control rate, defined as complete response + partial response + stable disease, was 48% (12 patients).The median duration of resp...