The FDA accepted and granted priority review to the supplemental biologics license application for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations, according to Bristol-Myers Squibb (BMS).
The agency set a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020.
BMS based its supplemental biologics license application on data from part 1 of the multi-part, open-label phase III CheckMate -227 trial, designed to evaluate nivolumab in combination with ipilimumab, compared with chemotherapy, in patients with previously untreated NSCLC. In part 1, the researchers are evaluating 2 arms:
- Nivolumab plus low-dose ipilimumab or nivolumab monotherapy versus chemotherapy in patients whose tumors express PD-L1 (part 1a)
- Nivolumab plus low-dose ipilimumab or nivolumab plus chemotherapy versus chemotherapy in patients whose tumors express PD-L1 (part 1b)
In addition, part 2 of the study is evaluating nivolumab plus chemotherapy versus chemotherapy, regardless of PD-L1 status.
The co-primary endpoints in part 1 of the study were overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in part 1a) 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).
The combination demonstrated significant improvement in OS versus chemotherapy alone. Moreover, the safety profile of the regimen was consistent with previously reported studies and no new safety signals were observed.
Part 2 did not meet its primary endpoint for OS for nivolumab plus chemotherapy versus chemotherapy alone, in patients with non-squamous NSCLC.
“The FDA’s acceptance of our application for Opdivo plus Yervoy represents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year,” Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb, said in a press release. “Lung cancer is the third tumor type where the combination of Opdivo and Yervoy has demonstrated significant long-term overall survival benefit in a randomized phase III trial, which further validates the immunologic rationale for dual immuno-oncology therapy.”
Bristol-Myers Squibb. U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer. Available from: https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-1. Accessed: January 15, 2020.