FDA approves immunotherapy combination for first-line treatment of metastatic NSCLC
The FDA approved nivolumab plus ipilimumab for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1.
The approval applies to use of the agents for patients with PD-L1 expression of at least 1% as determined by an FDA-approved test who have no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Nivolumab (Opdivo, Bristol-Myers Squibb) is an anti-PD-1 antibody. Ipilimumab (Yervoy, Bristol-Myers Squibb) is an anti-CTLA-4 antibody.
The FDA based the approval on results of the randomized CHECKMATE-227 trial, which included patients with metastatic or recurrent NSCLC who received no prior anticancer therapy.
One part of the open-label trial included 793 patients with PD-L1 tumor expression of 1% or greater.
Researchers randomly assigned 396 patients to nivolumab dosed at 3 mg/kg every 2 weeks plus ipilimumab dosed at 1 mg/kg every 6 weeks. The other 397 patients received platinum-doublet chemotherapy.
Results showed significantly longer median OS in the nivolumab-ipilimumab group (17.1 months vs. 14.9 months; HR = 0.79; 95% CI, 0.67-0.94).
The combination also appeared associated with a higher confirmed overall response rate by blinded independent central review (36% vs. 30%) and longer median response duration (23.2 months vs. 6.2 months).
The most common adverse reactions among patients assigned the nivolumab-ipilimumab combination included fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, dyspnea, cough, pruritis, nausea and hepatitis.
The FDA previously granted priority review to the nivolumab-ipilimumab combination for this indication.
The agency also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies Inc.) as a companion diagnostic device to guide selection of patients with NSCLC who are appropriate for treatment with the nivolumab-ipilimumab combination.