Dr. Lopes on the FDA Approval of Nivolumab/Ipilimumab in NSCLC

Gilberto De Lima Lopes, MD, associate professor of clinical oncology and associate director of global oncology, Sylvester Comprehensive Cancer Center, University of Miami Health System, discusses the FDA approval of nivolumab (Opdivo) and ipilimumab (Yervoy) in non–small cell lung cancer (NSCLC).

On May 15, 2020, the FDA approved the combination of nivolumab and ipilimumab for the first-line treatment of patients with metastatic or recurrent NSCLC that does not have EGFR or ALK genomic tumor aberrations.

The approval is based on findings from part 1 of the phase 3 CheckMate-227 trial, in which nivolumab combined with ipilimumab demonstrated a significant improvement in overall survival (OS) compared with chemotherapy alone in patients with previously untreated NSCLC. In a cohort of patients with PD-L1 expression ≥1%, the median OS with nivolumab and ipilimumab compared with chemotherapy was 17.1 months and 14.9 months, respectively (HR, 0.79; 97.72% CI, 0.65-0.96; P = .007). Moreover, the median OS was 17.1 months with the combination and 13.9 months with chemotherapy in all randomized patients, regardless of PD-L1 expression status (HR, 0.73; 95% CI, 0.64-0.84).

The safety profile of the combination was also consistent with previously reported trials. The approval provides another option for patients in the frontline setting, says Lopes. How the dual immunotherapy combination will compare with that of chemotherapy has yet to be fully discerned, concludes Lopes.