{"id":538914,"date":"2021-09-15T18:09:07","date_gmt":"2021-09-15T22:09:07","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bioxcel-therapeutics-presents-results-from-ongoing-phase-2-trial-of-bxcl701-in-combination-with-keytruda-in-aggressive-forms-of-prostate-cancer-at-esmo\/"},"modified":"2021-09-15T18:09:07","modified_gmt":"2021-09-15T22:09:07","slug":"bioxcel-therapeutics-presents-results-from-ongoing-phase-2-trial-of-bxcl701-in-combination-with-keytruda-in-aggressive-forms-of-prostate-cancer-at-esmo","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bioxcel-therapeutics-presents-results-from-ongoing-phase-2-trial-of-bxcl701-in-combination-with-keytruda-in-aggressive-forms-of-prostate-cancer-at-esmo\/","title":{"rendered":"BioXcel Therapeutics Presents Results from Ongoing Phase 2 Trial of BXCL701 in Combination with KEYTRUDA\u00ae in Aggressive Forms of Prostate Cancer at ESMO"},"content":{"rendered":"
\n

\n BXCL701 plus KEYTRUDA\u00ae (pembrolizumab) demonstrates encouraging anti-tumor activity in heavily pre-treated mCRPC patients with adenocarcinoma<\/em>
\n \n <\/p>\n

\n BXCL701 combination continues to exhibit favorable safety profile; patient enrollment continues as per protocol<\/em>\n <\/p>\n

NEW HAVEN, Conn., Sept. 15, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced data from its ongoing Phase 1b\/2 trial of BXCL701, the Company’s investigational, oral innate immunity activator, in metastatic castration-resistant prostate carcinoma (mCRPC) in a poster presentation at the 2021 European Society for Medical Oncology (ESMO) Congress.<\/p>\n

\u201cThese data lay a strong foundation for the broad potential of BXCL701 in combination with pembrolizumab, including for heavily pre-treated mCRPC patients with adenocarcinoma, an aggressive tumor for which there are few available treatment options,\u201d said Vincent J. O\u2019Neill, M.D., Senior Vice President and Chief Medical Officer of BioXcel. \u201cThe study demonstrated that 26% of patients in the adenocarcinoma cohort achieved a composite response, and all responders experienced a decrease in tumor size. Further, the majority of these responders who received BXCL701 in combination with pembrolizumab did not have strong predictive markers of pembrolizumab response. We believe BXCL701 has the potential to be the most advanced orally available innate immune activator and to inflame the tumor micro-environment, thus making tumors more responsive to immunotherapies, including the PD-1 inhibitor, pembrolizumab. We look forward to the continued evaluation of BXCL701 in mCRPC in our adenocarcinoma cohort, as well as in our small-cell neuroendocrine carcinoma (SCNC) cohort, which both continue to enroll patients.\u201d<\/p>\n

The Phase 1b\/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab, in men with mCRPC adenocarcinoma and SCNC phenotypes. Eligibility criteria include progression as defined by PCWG3 criteria and at least 1 line of taxane chemotherapy for inclusion in the adenocarcinoma cohort, or at least 1 prior line of chemotherapy for inclusion in the SCNC cohort. 32 eligible mCRPC patients received 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of Cycle 1) plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary endpoint of the trial is composite response rate, with a target of achieving >15% response. Secondary endpoints include duration of response, progression-free survival, and overall survival.<\/p>\n

\n KEY FINDINGS \u2013 ADENOCARCINOMA <\/strong>\n <\/p>\n