Overall, approximately 40% of patients had tumor PD-L1 expression < 1%. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.In the open-label trial, 719 patients from sites in 19 countries were randomly assigned between August 2017 and January 2019 to receive nivolumab/ipilimumab with two cycles of histology-based platinum doublet chemotherapy (n = 361) or four cycles of chemotherapy alone (control group, n = 358). The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc.
KEYNOTE 189 OVERALL SURVIVAL UPDATE FULL
For full disclosures of the study authors, visit. Reck, of the Lung Clinic Grosshansdorf, is the corresponding author for the Journal of Clinical Oncology article.ĭisclosure: The study was supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc. The investigators concluded, “Pembrolizumab provides a durable, clinically meaningful long-term overall survival benefit vs chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%.”ĭr. Exposure-adjusted adverse event rates in the total study population decreased over time in both treatment groups for treatment-related adverse events, immune-mediated adverse events, and infusion-related reactions. No new safety signals were identified in long-term follow-up. Five patients (41.7%) had treatment-related adverse events during the second course all were grade 1 or 2, including grade 1 hyperthyroidism in one patient. Objective response was observed in four patients and stable disease was observed in six. Among these patients, eight (66.7%) were alive at data cutoff five (41.7%) were alive without disease progression, and three (25.0%) had not received subsequent therapy. Median time from last dose of second course to data cutoff was 15.2 months (range = 0.4–29.6 months). Among patients who completed 35 cycles, treatment-related adverse events occurred in 87.2% (grade 3–4 in 15.4%), consistent with the overall as-treated population.Ī total of 12 patients received a second course of pembrolizumab on study after investigator-assessed disease progression. A total of 18 patients (46.2%) were alive without disease progression or subsequent therapy for NSCLC. At data cutoff, 32 were alive, and the overall survival rate at 36 months from completion of 35 cycles (approximately 5 years) was 81.4%. Estimated rates at 3, 4, and 5 years were 39.5% vs 15.0%, 31.4% vs 14.0%, and 26.3% vs 13.0%.Ī total of 39 patients (25.8%) in the pembrolizumab group completed 35 cycles of treatment. Median progression-free survival–2 (ie, time from randomization to subsequent disease progression after initiation of new anticancer therapy or death from any cause) was 24.1 months (95% CI = 15.0–31.4 months) in patients initially randomly assigned to pembrolizumab vs 8.5 months (95% CI = 7.3–11.4 months) among those initially randomly assigned to chemotherapy (HR = 0.51, 95% CI = 0.39–0.67). Martin Reck, MD, PhD, and colleagues Tweet this quote Pembrolizumab provides a durable, clinically meaningful long-term overall survival benefit vs chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%. Estimates of progression-free survival rates at 3, 4, and 5 years were 22.8% vs 4.1%, 16.4% vs 1.4%, and 12.8% vs no evaluable patients. Median progression-free survival was 7.7 months (95% CI = 6.1–10.2 months) in the pembrolizumab group vs 5.5 months (95% CI = 4.2–6.2 months) in the chemotherapy group (HR = 0.50, 95% CI = 0.39–0.65). Median overall survival was 26.3 months (95% confidence interval = 18.3–40.4 months) in the pembrolizumab group vs 13.4 months (95% CI = 9.4–18.3 months) in the chemotherapy group (hazard ratio = 0.62, 95% CI = 0.48–0.81). A total of 80 patients (52.9%) in the pembrolizumab group received additional anticancer therapy, including 12 who received a second course of pembrolizumab on study. Among patients initially assigned to chemotherapy, 99 (66.0%) received subsequent anti–PD-1 or PD-L1 therapy (including 83 who crossed over to pembrolizumab on study), representing a 66.0% effective crossover rate. Median time from random assignment to data cutoff in June 2020 was 59.9 months (range = 55.1–68.4 months). The primary endpoint was progression-free survival, with overall survival as a secondary endpoint. Patients with disease progression in the chemotherapy group could cross over to receive pembrolizumab. In the trial, 305 patients with TPS ≥ 50% and no sensitizing EGFR or ALK alterations were randomly assigned to receive pembrolizumab at 200 mg once every 3 weeks for up to 35 cycles (n = 154) or platinum-based chemotherapy (n = 151).
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