BioXcel Therapeutics Unveils Complete Data From BXCL701/Keytruda Combo Study In Prostate Cancer Subtype

BioXcel Therapeutics Inc BTAI announced full data from its Phase 2a trial of BXCL701 in combination with Merck & Co Inc's MRK Keytruda (pembrolizumab) in small cell neuroendocrine (SCNC) variant metastatic castration-resistant prostate cancer (mCRPC) patients.
The trial included patients after at least one prior line of chemotherapy for locally advanced or metastatic prostate cancer.
In the evaluable patient cohort (n = 28), 7 (25%) patients achieved a composite response, the trial's primary endpoint.
Partial response (PR) was observed in 5 (20%) patients (4 confirmed PR, one unconfirmed PR). The disease control rate was 48% (12 patients).
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The median duration of response for both composite responses and partial responses was 6+ months as of the data cutoff on December 19, 2022.
6 out of 34 patients (18%) in the safety population experienced serious adverse events (SAEs) possibly related to or related to BXCL701 or pembrolizumab, and 6 (18%) patients discontinued any drug due to a treatment-related AE.
The company plans to initiate a randomized trial evaluating BXCL701 plus pembrolizumab versus BXCL701 monotherapy.
Price Action: BTAI shares are up 2.82% at $33.55 on the last check Tuesday.