Merck to stop phase 3 trial of Keytruda plus Lynparza for lung cancer patients
Rahway: Merck, known as MSD outside of the United States and Canada, has 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.
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