Merck Stoping Phase 3 KEYLYNK-010 Trial Investigating KEYTRUDA In Combination With LYNPARZA

(RTTNews) - Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Tuesday that it will stop the Phase 3 KEYLYNK-010 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with LYNPARZA, a PARP inhibitor, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.

Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC) after the DMC reviewed data from a planned interim analysis.

At the interim analysis, the combination of KEYTRUDA and LYNPARZA did not demonstrate a benefit in overall survival (OS), one of the study's dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide.

The trial's other dual primary endpoint, radiographic progression free survival (rPFS), was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm.

Merck has an extensive clinical development program in prostate cancer evaluating KEYTRUDA as monotherapy and in combination with LYNPARZA and other anti-cancer therapies. Ongoing trials evaluating KEYTRUDA include the Phase 2 trials KEYNOTE-199 and KEYNOTE-365, and Phase 3 registrational trials KEYNOTE-641, KEYNOTE-921 and KEYNOTE-991.