Opdivo + Yervoy success in Phase III CHECKMATE 227 study for NSCLC patients with high tumor mutational burden.- BMS.
Bristol-Myers Squibb Company has announced initial results from the pivotal Phase III study, CheckMate -227 , evaluating the Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) greater than 10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival (PFS) versus chemotherapy (HR 0.58; 97.5% CI: 0.41 to 0.81; p=0.0002). The PFS benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumor histology. Additionally, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB greater than 10 mut/Mb (HR 0.79; 95% CI: 0.56 to 1.10). These data were featured during the official press program at the American Association for Cancer Research (AACR) Annual Meeting 2018 in Chicago (Abstract #CT077). Findings will be presented at 11:35-11:55 AM CDT during the Clinical Trials Plenary Session, Immunotherapy Combinations: The New Frontier in Lung Cancer, and simultaneously published in The New England Journal of Medicine.
Grade 3-4 treatment-related adverse events (AEs) with the combination were skin reactions (34%), endocrine (23%), gastrointestinal (18%), hepatic (15%), pulmonary (8%), hypersensitivity (4%) and renal (4%) events. Overall, treatment-related deaths occurred in 1% of patients treated in both the combination and chemotherapy arms.
See- "Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden"- Matthew D. Hellmann, M.D., Tudor-Eliade Ciuleanu, M.D., Adam Pluzanski, M.D., Jong Seok Lee, M.D., Gregory A. Otterson, M.D., Clarisse Audigier-Valette, M.D., Elisa Minenza, M.D., Helena Linardou, M.D., Sjaak Burgers, M.D., Pamela Salman, M.D., Hossein Borghaei, D.O., Suresh S. Ramalingam, M.D., et al.-April 16, 2018 DOI: 10.1056/NEJMoa1801946.
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