![]() ![]() The estimated OS rate at 12 months was 69.2% in the pembrolizumab group vs 49.4% in the placebo group (hazard ratio for death, 0.49 95% CI, 0.38-0.64 P<.001). LG We saw an improvement in OS with pembrolizumab vs placebo. H&O What did you and your colleagues find? The primary endpoints were overall survival (OS) and progression-free survival (PFS). Crossover from the chemotherapy/placebo arm to the chemotherapy/pembrolizumab arm was allowed if confirmed progression occurred. Patients with EGFR or ALK mutations, who are candidates for oncogene-directed therapy, were excluded from the trial. ![]() We randomly assigned 616 patients with metastatic nonsquamous NSCLC in a 2:1 ratio to receive either standard platinum/pemetrexed chemotherapy plus pembrolizumab or platinum/pemetrexed plus placebo. The majority of the sites were in Europe. LG KEYNOTE-189 is a randomized, placebo-controlled trial that was conducted in 16 countries. H&O Can you describe the design of the KEYNOTE-189 trial? Pemetrexed (Alimta, Lilly) and platinum have been shown to decrease myeloid-derived suppressor cells (MDSCs), enhance T-cell activation, and promote the T-cell infiltration of tumors. Given the disappointing results with chemotherapy alone and immunotherapy alone, we wanted to see if chemotherapy could make tumors more immunogenic and responsive to a programmed death 1 (PD-1) inhibitor like pembrolizumab (Keytruda, Merck). ![]() Second, only a small subset-approximately 20%-of patients with NSCLC benefit from immunotherapy as a single agent. First, the benefits of chemotherapy alone in these patients are modest. LG KEYNOTE-189 (Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer) looked at adding immunotherapy to chemotherapy in the first-line treatment of patients who have advanced non–small cell lung cancer (NSCLC) without actionable mutations. H&O What made you and your colleagues decide to undertake the KEYNOTE-189 trial? ![]()
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