BioXcel, keeping cards close to its chest, teases phase 2 Keytruda combination tri | BTAI Message Board Posts


BioXcel Therapeutics, Inc.

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Msg  36 of 42  at  1/12/2023 4:13:28 PM  by

jerrykrause


BioXcel, keeping cards close to its chest, teases phase 2 Keytruda combination tri

 
Pharma & Healthcare Monitor Worldwide
 

BioXcel, keeping cards close to its chest, teases phase 2 Keytruda combination trial data drop

 
 

BioXcel Therapeutics has reported promising top-line data including an encouraging response rate in its phase 2 Keytruda combination clinical trial. What is promising and encouraging about the data? That remains under wraps, with the biotech opting against providing even a smidgen of information ahead of the presentation of the full data next month.

The phase 2 clinical trial tested BXCL701, an oral innate immune activator, in combination with Merck & Co.s blockbuster checkpoint inhibitor Keytruda in people with small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC). BioXcel began studying the combination in light of evidence that BXCL701 may improve the effect of Keytruda in immunologically cold tumors by boosting levels of key proinflammatory cytokines and activating the inflammasome.

In an earlier interim analysis, BioXcel reported a 33% response rate in patients with SCNC, an aggressive form of prostate cancer. Most of the 15 people included in the interim analysis had previously received platinum chemotherapy. Now, the biotech has published an upbeat assessment of the full data without disclosing whether the trial hit its primary endpoint or sharing any results.

Vincent ONeill, M.D., chief R&D officer at BioXcels wholly owned subsidiary OnkosXcel Therapeutics, set out the little the company has revealedand what he thinks it meansin a statement on the study.

We are pleased that BXCL701 in combination with pembrolizumab has demonstrated an encouraging response rate in this difficult-to-treat cancer with no currently approved FDA therapies, ONeill said. BXCL701s promising profile as an oral innate immune activator with a large safety dataset and novel mechanism of action ... reinforces our confidence in BXCL701s potential to enable checkpoint inhibitor therapy in traditionally cold cancers.

BioXcel will present the full data next month at the American Society of Clinical Oncology Genitourinary Cancers Symposium. The data drop will reveal the outcomes seen in the 28 evaluable SCNC patients in a clinical trial that used a composite response rate as its primary endpoint.



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