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FDA accepts application for Opdivo-Yervoy, first immuno-oncology combination for lung cancer
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The FDA accepted the application for nivolumab plus low-dose ipilimumab for the treatment of first-line advanced non-small cell lung cancer with high tumor mutational burden.
This marks the first application accepted by the FDA for a combination of two immuno-oncology agents for the treatment of lung cancer.
Researchers defined high tumor mutational burden by at least 10 mutations per megabase.
The FDA based this acceptance on results from part 1 of the CheckMate-227 study, a global phase 3 study of nivolumab (Opdivo, Bristol-Myers Squibb) plus low-dose ipilimumab (Yervoy, Bristol-Myers Squibb) compared with chemotherapy.
As HemOnc Today previously reported, researchers presented results from part 1 of CheckMate-227 at the American Association for Cancer Research Annual Meeting, as well as in The New England Journal of Medicine.
Among patients with tumor mutational burden of at least 10 mutations per megabase, those assigned nivolumab plus ipilimumab achieved significantly longer PFS than those assigned chemotherapy (HR = 0.58; 97.5% CI, 0.41-0.81).
The immunotherapy combination also appeared associated with a higher objective response rate (45.3% vs. 26.9%) and longer median duration of response (not reached vs. 5.4 months). Median time to response was 2.7 months with the nivolumab-ipilimumab combination and 1.5 months with chemotherapy.
“Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients,” Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb, said in a press release. “We look forward to working with the FDA throughout the review process to bring this important treatment option to patients.”
The FDA set an action date of Feb. 20, 2019.
Nivolumab plus ipilimumab is indicated for unresectable or metastatic melanoma and intermediate or poor-risk, previously untreated advanced renal cell carcinoma.