FDA Grants Priority Review to Nivolumab/Ipilimumab in First-Line Treatment of Lung Cancer
Posted: Wednesday, April 15, 2020
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted a supplemental biologics license application for the PD-1 inhibitor nivolumab (Opdivo) plus the monoclonal antibody ipilimumab (Yervoy) with a limited course of chemotherapy. The drug combination is intended as a first-line regimen for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The Priority Review designation was based on results from the open-label, multicenter phase III CheckMate 9LA clinical trial. Patients enrolled in the study had metastatic NSCLC, regardless of PD-L1 expression and histology. The patients were randomly assigned to receive either 360 mg every 3 weeks of nivolumab plus 1 mg/kg every 6 weeks of ipilimumab combined with two cycles of chemotherapy for 2 years or until disease progression or unacceptable toxicity or four cycles of chemotherapy followed by optional pemetrexed maintenance therapy if eligible until disease progression or toxicity.
The trial met its primary endpoint of improved overall survival in the experimental arm compared with the control arm. Nivolumab has been associated with immune-mediated adverse events, such as pneumonitis, colitis, hepatitis, neuropathies, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions and dermatitis, and encephalitis. Immune-mediated adverse reactions associated with ipilimumab include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.
