U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden =10 mut/Mb

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy(ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019.

Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, "Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients. We look forward to working with the FDA throughout the review process to bring this important treatment option to patients."

The application was based on results from Part 1 of CheckMate -227, the first and only global Phase 3 study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum. These data were presented at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine.

About CheckMate -227

CheckMate -227 is an ongoing, multi-part, open-label global Phase 3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer across squamous and non-squamous tumor histologies.

Part 1a: Opdivo plus low-dose Yervoy or Opdivo monotherapy versus chemotherapy in patients whose tumors express PD-L1

Part 1b: Opdivo plus low-dose Yervoy or Opdivo plus chemotherapy versus chemotherapy in patients whose tumors do not express PD-L1

Part 2: Opdivo plus chemotherapy versus chemotherapy, regardless of PD-L1 or tumor mutational burden (TMB) status

There are two co-primary endpoints in Part 1 for Opdivo plus low-dose Yervoy versus chemotherapy: overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a, which continues to final analysis) and progression-free survival (PFS) in patients with TMB ≥10 mut/Mb across the PD-L1 spectrum (assessed in patients enrolled across Parts 1a and 1b). TMB status was assessed using the validated assay, FoundationOne CDx.