FDA Accepts Application for First-Line Combination Immunotherapy in Subgroup With NSCLC
Posted: Tuesday, July 3, 2018
Recently, the U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with tumor mutational burden ≥ 10 mutations/megabase.
The application was based on results from Part 1 of the CheckMate-227 study, an ongoing, multipart, open-label global phase III trial evaluating nivolumab-based regimens versus platinum-doublet chemotherapy in the first-line treatment of patients with advanced NSCLC across squamous and nonsquamous tumor histologies.
A total of 1,096 patients were grouped to receive nivolumab plus ipilimumab (n = 550) or sunitinib (n = 546). At a median follow-up of 25.2 months in intermediate- and poor-risk patients, the 18-month overall survival rate was 75% with nivolumab plus ipilimumab and 60% with sunitinib. The objective response rate was 42% versus 27%, and the complete response rate was 9% versus 1%, respectively. The median progression-free survival was 11.6 months and 8.4 months, respectively. Treatment-related adverse events occurred in 93% of patients in the nivolumab/ipilimumab group and 97% of the sunitinib group; grade 3 or 4 events occurred in 46% and 63%, respectively.
These data were presented at the 2018 American Association for Cancer Research Annual Meeting (Abstract CT077), simultaneously published in The New England Journal of Medicine, and covered by JNCCN 360.
