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January 15, 2020
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FDA grants priority review to Opdivo-Yervoy combination for first-line non-small cell lung cancer

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The FDA granted priority review to the combination of nivolumab plus ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK mutations, according to a press release from the agents’ manufacturer.

The supplemental biologics license application for nivolumab (Opdivo, Bristol-Myers Squibb), an anti-PD-1 antibody, plus ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody, is based on data from part 1 of the phase 3 CheckMate-227 trial.

In part 1a, patients with advanced squamous or nonsquamous NSCLC and PD-L1 expression received first-line treatment with nivolumab plus ipilimumab or nivolumab alone vs. chemotherapy. In part 1b, which included patients whose tumors did not express PD-L1, patients received nivolumab plus ipilimumab or nivolumab plus chemotherapy vs. chemotherapy alone.

As Healio previously reported, data showed that the first part of the trial’s two co-primary endpoints — OS among patients with PD-L1 expression of 1% or greater and PFS among patients with a tumor mutational burden of at least 10 mutations/Mb, regardless of PD-L1 status — were met in the comparison of nivolumab-ipilimumab vs. chemotherapy.

Part 2 of the study — which evaluated the addition of nivolumab to chemotherapy, regardless of PD-L1 expression — did not meet its primary endpoint of OS for patients with nonsquamous NSCLC.

Researchers reported no new safety signals for the combination.

“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 the 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 3 trial, which further validates the immunologic rationale for dual immuno-oncology therapy.”

The FDA is expected to make a decision on this application by May 15.