The Phase III KEYLYNK-006 trial evaluating Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, in combination with maintenance Lynparza (olaparib), a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
The KEYLYNK-006 trial enrolled 1,005 patients with metastatic non-squamous NSCLC with no EGFR, ALK or ROS1 genomic tumour aberrations. Subjects initially received Keytruda in combination with pemetrexed plus investigator’s choice of platinum chemotherapy. The 672 patients who achieved a complete or partial response, or had stable disease, were subsequently randomized in the maintenance portion of the study to receive Keytruda plus either UK pharma major AstraZeneca’s (LSE: AN) Lynparza or pemetrexed.
The US pharma giant explained that, in the KEYLYNK-006 trial, Keytruda in combination with chemotherapy followed by Keytruda plus maintenance Lynparza did not meet the study’s pre-specified statistical criteria for OS or PFS compared to Keytruda in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by Keytruda plus maintenance chemotherapy (pemetrexed).
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