Merck discontinues trial evaluating Keytruda combination in NSCLC

Merck will stop the Phase 3 KEYLYNK-008 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with maintenance Lynparza, a PARP inhibitor, for the treatment of patients with metastatic squamous non-small cell lung cancer, or NSCLC. Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee. At the interim analysis 3, Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not demonstrate an improvement in overall survival, one of the study’s dual primary endpoints, compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo. The study’s other dual primary endpoint, progression-free survival, was not statistically significant at the second interim analysis, but there was a numerical improvement compared to the control arm. The safety profile in this trial was consistent with that observed in previously reported studies for the individual therapies and no new safety signals were identified.