This is an archive of papers published by the staff and faculty of Fox Chase Cancer Center. For questions about content, please contact Talbot Research Library
Last updated on
Awad MM , Gadgeel SM , Borghaei H , Patnaik A , Yang JC , Powell SF , Gentzler RD , Martins RG , Stevenson JP , Altan M , Jalal SI , Panwalkar A , Gubens M , Sequist LV , Saraf S , Zhao B , Piperdi B , Langer CJ
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC
J Thorac Oncol. 2021 jan;16(1) :162-168
PMID: 33069888 URL: https://www.ncbi.nlm.nih.gov/pubmed/33069888
AbstractINTRODUCTION: In cohort G of KEYNOTE-021 (NCT02039674), first-line pembrolizumab plus pemetrexed-carboplatin significantly improved the objective response rate and progression-free survival versus chemotherapy alone with manageable toxicity in advanced nonsquamous NSCLC. We report the long-term outcomes from this study. METHODS: Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR or ALK alterations were randomly assigned 1:1 to receive open-label pemetrexed 500 mg/m(2) plus carboplatin at area under the concentration-time curve of 5 mg/mL/min (four cycles) with or without pembrolizumab 200 mg (up to 2 years), with optional pemetrexed maintenance, each administered every 3 weeks. Eligible patients could crossover from the chemotherapy arm to pembrolizumab monotherapy after progression. Responses were assessed per the Response Evaluation Criteria in Solid Tumors version 1.1. RESULTS: After the median time of 49.4 months from randomization to data cutoff, objective response rate (58% versus 33%) and progression-free survival (median: 24.5 versus 9.9 mo; hazard ratio: 0.54; 95% confidence interval: 0.35‒0.83) remained improved with pembrolizumab combination (n = 60) versus chemotherapy (n = 63), regardless of programmed death ligand 1 status. Median overall survival was 34.5 versus 21.1 months (hazard ratio: 0.71; 95% confidence interval: 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒programmed death (ligand) 1 therapy. Among the 12 patients who completed 2 years of pembrolizumab, 92% were alive at data cutoff; the estimated 3-year duration of response rate was 100%. Grade 3 to 5 treatment-related adverse events occurred in 39% of patients receiving pembrolizumab combination and 31% receiving chemotherapy. CONCLUSIONS: First-line pembrolizumab plus pemetrexed-carboplatin continued to show improved response and survival versus chemotherapy alone in advanced nonsquamous NSCLC, with durable clinical benefit in patients who completed 2 years of therapy. No new safety signals were observed with longer follow-up.
Notes1556-1380 Awad, Mark M Gadgeel, Shirish M Borghaei, Hossein Patnaik, Amita Yang, James Chih-Hsin Powell, Steven F Gentzler, Ryan D Martins, Renato G Stevenson, James P Altan, Mehmet Jalal, Shadia I Panwalkar, Amit Gubens, Matthew Sequist, Lecia V Saraf, Sanatan Zhao, Bin Piperdi, Bilal Langer, Corey J Journal Article United States J Thorac Oncol. 2021 Jan;16(1):162-168. doi: 10.1016/j.jtho.2020.09.015. Epub 2020 Oct 15.