Merck announces KEYNOTE-598 trial evaluating Keytruda plus ipilimumab versus Keytruda monotherapy for metastatic non-small cell lung cancer to stop for futility and patients to discontinue.

-Merck announced that it will be stopping KEYNOTE-598, a Phase III trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with ipilimumab (Yervoy), compared with Keytruda monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] greater than 50%) with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of Keytruda and ipilimumab showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the study’s dual primary endpoints, compared with Keytruda alone and crossed futility boundaries. No new safety signals for Keytruda monotherapy were observed, however the combination of Keytruda and ipilimumab was associated with a higher incidence of grade 3-5 adverse events (AEs), serious AEs, and AEs leading to discontinuation or death, compared with Keytruda monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study .