BioXcel reports overall survival results from Phase 2 trial of BXCL701

BioXcel Therapeutics announced positive overall survival data from its Phase 2 trial of BXCL701, the Company’s investigational oral innate immune activator, in combination with KEYTRUDA in patients with metastatic castration-resistant prostate cancer of adenocarcinoma phenotype, the most common form of the disease. As of a September 6, 2023 data cutoff, evaluable patients with adenocarcinoma showed a median OS of 15.5 months, and a 12-month survival rate of 59%. “Patients with mCRPC who have failed androgen deprivation and taxane-based chemotherapy have few remaining treatment options and, unfortunately, KEYTRUDA to date has not shown additional benefit in this setting,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “Therefore, we are highly encouraged by these combination data bearing in mind historical data with checkpoint inhibitor monotherapy. In addition, we now have a second positive dataset in a separate cold tumor histology, further increasing our belief that BXCL701 has the potential to inflame the tumor microenvironment of cold tumors, thereby sensitizing them to checkpoint inhibition. We believe the data warrant further evaluation of BXCL701 in this setting and look forward to determining the development path for this program following our end of Phase 2 meeting with the FDA scheduled for December.”