Keytruda and Lynparza early findings for treatment of prostate cancer.- Merck Inc.

Merck Inc., announced the presentation of interim data from the Phase 1b/II KEYNOTE-365 umbrella trial investigating Keytruda, Merck�s anti-PD-1 therapy, in combination with various agents for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). These early findings show anti-tumor activity across three cohorts of the study, which investigated Keytruda in combination with Lynparza (Cohort A, Abstract #145); docetaxel and prednisone (Cohort B, Abstract #170); and enzalutamide (Cohort C, Abstract #171) � with a safety profile consistent with each therapy alone. These results are being presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco.

Based on the findings, Merck is initiating three new pivotal Phase III trials with Keytruda in combination with Lynparza (KEYLYNK-010, NCT03834519), docetaxel and prednisone (KEYNOTE-921, NCT03834506) and enzalutamide (KEYNOTE-641, NCT03834493).

Merck�s existing clinical development program in metastatic prostate cancer includes studies evaluating Keytruda and Lynparza as monotherapy and in combination with other anti-cancer therapies with various mechanisms of action. Ongoing trials include the Phase II KEYNOTE-199 trial for Keytruda monotherapy and, in collaboration with AstraZeneca, the Phase III trials PROfound evaluating Lynparza monotherapy and PROPEL evaluating Lynparza in combination with abiraterone as a first-line therapy in patients with mCRPC. With the initiation of KEYLYNK-010, KEYNOTE-921 and KEYNOTE-641, Merck now has the largest clinical program with an anti-PD-1 therapy in prostate cancer and the only program to evaluate overall survival (OS) as a co-primary endpoint across three Phase III trials.