Merck stops Phase 3 KEYLYNK-008 KEYTRUDA trial in NSCLC after it did not not demonstrate improvement in overall survival

Merck (MRK) announced that it 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 (NSCLC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3). At the interim analysis 3, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus LYNPARZA did not demonstrate an improvement in overall survival (OS), 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 (PFS), 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. Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. Data from this study will be presented at an upcoming scientific congress.

“While there have been significant scientific advancements in lung cancer research in recent years, unmet needs remain for patients with advanced non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We sincerely thank the patients and investigators for their participation in this study, and we will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with lung cancer.”

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies evaluating KEYTRUDA-based combinations in NSCLC include KEYLYNK-006, KEYLYNK-012, KEYVIBE-003, KEYVIBE-006 and KEYVIBE-007.