CheckMate 817: Safety of flat-dose nivolumab (nivo) plus weight-based ipilimumab (ipi) for the first lie (1 L) treatment of advanced non-small cell lung cancer (NSCLC)

JR Fischer, L Paz-Ares,L Urban, C Audigier-Valette,F Grossi, K Jao, JS Aucoin,H Linardou, E Vladimirovna Poddubskaya, A Cuiioni Fontecedro,HJM Groen,K Vermaelen, M Bourhaba, D Kowalski, R Narayana Pillai,DR Spigel,S Ahmed, W Hu, D Vickery,J Fiore, N Ready

60. Kongress der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e. V.Pneumologie（2019）

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摘要

Background CheckMate (CM) 227 demonstrated significant, clinically meaningful progression-free survival benefit with 1 L nivo 3 mg/kg Q2W plus low-dose ipi 1 mg/kg Q6W vs. chemotherapy in patients (pts) with advanced NSCLC and tumor mutational burden (TMB) ≥ 10 mutations/Mb. Dose and schedule for this combination were optimized for 1 L NSCLC in CM 012 and further validated in CM 568 and CM 227. Flat dosing of nivo (240 mg Q2W) may simplify treatment while providing comparable exposure, and was recently approved for previously treated NSCLC. CM 817 (NCT02869789) is a multi-cohort, open-label phase 3b/4 study of the safety and efficacy of flat-dose nivo plus weight-based low-dose ipi in recurrent/metastatic NSCLC. We report safety results of this regimen in the 1 L setting from cohort A

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