FDA grants priority review to first-line lung cancer regimen
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The FDA granted priority review to nivolumab plus ipilimumab combined with a limited chemotherapy course as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer.
The designation applies to use of the regimen for patients with no EGFR or ALK genomic tumor aberrations.
Nivolumab (Opdivo, Bristol-Myers Squibb) is an anti-PD-1 antibody, and ipilimumab (Yervoy, Bristol-Myers Squibb) is an anti-CTLA-4 antibody. The combination is approved in the United States for treatment of certain patients with melanoma, renal cell carcinoma, colorectal cancer and hepatocellular carcinoma.
The FDA granted priority review to the lung cancer indication based on results of the randomized phase 3 CheckMate -9LA trial, which assessed the combination as first-line treatment for patients with metastatic NSCLC regardless of PD-L1 expression or histology.
Researchers assigned patients in the experimental treatment group to nivolumab dosed at 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks, combined with two cycles of chemotherapy. Treatment continued for up to 2 years or until disease progression or unacceptable toxicity.
Patients in the control group received up to four cycles of chemotherapy alone, followed by optional pemetrexed maintenance therapy if eligible until disease progression or toxicity.
The study met its primary endpoint of improved OS in the intent-to-treat population.
The FDA is expected to make a decision on approval by Aug. 6.
“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for [patients with lung cancer],” Sabine Maier, MD, development lead for thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “We look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”