Merck presents data from new Phase 3 trials to treat mCRPC patients

Pharmaceutical major Merck & Co Inc., has apparently announced the launch of three late-stage studies for KEYTRUDA – its cancer immunotherapy. Trusted reports cite that these studies are being introduced as a combination treatment for the much-dreaded prostate cancer after the supposed drug depicted anti-tumor activity in an early-stage trial.

As per sources familiar with the knowledge of the matter, the findings of the Phase 1b/2 KEYNOTE-365 trial, investigating Merck’s anti-PD-1 therapy KEYTRUDA, in combination with myriad agents for treating patients suffering from mCRPC (metastatic castration-resistant prostate cancer), depicted anti-tumor activity across three study cohorts. One of these cohorts investigated KEYTRUDA in combination with LYNPARZA, the second cohort investigated KEYTRUDA in combination with docetaxel and prednisone, while the third cohort did so in conjunction with enzalutamide.

For the record, these results were presented at the 2019 ASCO GU (Genitourinary Cancers Symposium) in San Francisco.

According to an official press release by the company, Dr. Roy Baynes, Senior VP & chief medical officer, Merck, was quoted stating that at the very epicenter of the firm’s research program lies its commitment to investigate the massive potential of KEYTRUDA as a monotherapy and as a combination therapy to cater to the requirement of fundamental treatment in cancers that demand the deployment of additional therapies. The data presented at ASCO GU in conjunction with the unmet medical needs in patients with mCRPC encouraged the firm to initiate three new Phase 3 trials to analyze the KEYTRUDA combination regimens, Baynes added.

Incidentally, Merck’s current clinical development program in metastatic prostate cancer is inclusive of studies that evaluate KEYTRUDA and LYNPARZA as a monotherapy and in combination with anti-cancer therapies with other mechanisms of action. The present trials in existence include the Phase 3 trials PROfound analyzing LYNPARZA monotherapy in collaboration with AstraZeneca, PROPEL analyzing LYNPARZA in combination with abiraterone (as a first-line therapy) in mCRPC patients, and the Phase 2 KEYNOTE-199 trial for KEYTRUDA monotherapy.