FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden ≥ 10 mutations per megabase (mut/mb). The target FDA action date is February 20, 2019.

The application was based on results from part 1 of CheckMate-227, the first and only global phase III study to evaluate an immuno-oncology combination regimen vs chemotherapy in a population of first-line NSCLC patients with a tumor mutational burden ≥ 10 mut/mb, across squamous and nonsquamous tumor histologies and the programmed cell death ligand 1 (PD-L1) expression spectrum. These data were presented at the 2018 American Association for Cancer Research (AACR) Annual Meeting and published in The New England Journal of Medicine.

About CheckMate-227

CheckMate-227 is an ongoing, multipart, open-label, global phase III trial evaluating nivolumab-based regimens vs platinum-doublet chemotherapy in patients with first-line advanced NSCLC across squamous and nonsquamous tumor histologies. The study consists of the following parts:

  • Part 1a: nivolumab plus low-dose ipilimumab or nivolumab monotherapy vs chemotherapy in patients whose tumors express PD-L1
  • Part 1b: nivolumab plus low-dose ipilimumab or nivolumab plus chemotherapy vs chemotherapy in patients whose tumors do not express PD-L1
  • Part 2: nivolumab plus chemotherapy vs chemotherapy, regardless of PD-L1 or tumor mutational burden status.

There are two co-primary endpoints in part 1 for nivolumab plus low-dose ipilimumab vs chemotherapy: overall survival in patients whose tumors express PD-L1 (assessed in patients enrolled in part 1a, which continues to final analysis) and progression-free survival in patients with tumor mutational burden ≥ 10 mut/mb across the PD-L1 spectrum (assessed in patients enrolled across parts 1a and 1b). Tumor mutational burden was assessed using the validated assay FoundationOne CDx.

The primary endpoint in part 2 is overall survival, and the study is ongoing.

Nivolumab and ipilimumab are dosed as follows in this study: nivolumab, 3 mg/kg every 2 weeks, with low-dose ipilimumab, 1 mg/kg every 6 weeks.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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