![]() Treatment-related grade 3 to 5 adverse events were less frequent with pembrolizumab compared with chemotherapy (31.2% v 53.3%, respectively).ĬONCLUSION With prolonged follow-up, first-line pembrolizumab monotherapy continues to demonstrate an OS benefit over chemotherapy in patients with previously untreated, advanced NSCLC without EGFR/ALK aberrations, despite crossover from the control arm to pembrolizumab as subsequent therapy. As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapydespite substantial crossover to the immunotherapy groupin previously untreated patients with nonsmall cell lung cancer (NSCLC) and a PD. When adjusted for crossover using the two-stage method, the hazard ratio for OS for pembrolizumab versus chemotherapy was 0.49 (95% CI, 0.34 to 0.69) results using rank-preserving structural failure time and inverse probability of censoring weighting were similar. Eighty-two patients assigned to chemotherapy crossed over on study to receive pembrolizumab. Median OS was 30.0 months (95% CI, 18.3 months to not reached) with pembrolizumab and 14.2 months (95% CI, 9.8 to 19.0 months) with chemotherapy (hazard ratio, 0.63 95% CI, 0.47 to 0.86). ![]() At data cutoff (Jmedian follow-up, 25.2 months), 73 patients in the pembrolizumab arm and 96 in the chemotherapy arm had died. RESULTS Three hundred five patients were randomly assigned (pembrolizumab, n = 154 chemotherapy, n = 151). Crossover adjustment analysis was done using the following three methods: simplified two-stage method, rank-preserving structural failure time, and inverse probability of censoring weighting. The primary end point was progression-free survival OS was an important key secondary end point. Patients assigned to chemotherapy could cross over to pembrolizumab upon meeting eligibility criteria. PATIENTS AND METHODS Patients were randomly assigned to pembrolizumab 200 mg every 3 weeks (for up to 2 years) or investigator's choice of platinum-based chemotherapy (four to six cycles). We report an updated OS and tolerability analysis, including analyses adjusting for potential bias introduced by crossover from chemotherapy to pembrolizumab. PURPOSE In the randomized, open-label, phase III KEYNOTE-024 study, pembrolizumab significantly improved progression-free survival and overall survival (OS) compared with platinum-based chemotherapy in patients with previously untreated advanced non-small-cell lung cancer (NSCLC) with a programmed death ligand 1 tumor proportion score of 50% or greater and without EGFR/ALK aberrations.
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