FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
Opdivo and Yervoy are sponsored by Bristol-Myers Squibb Co.
FDA has also approved the PD-L1 IHC 28-8 pharmDx, sponsored by Agilent Technologies Inc., as a companion diagnostic device for selecting patients with NSCLC for treatment with nivolumab plus ipilimumab.
Efficacy was investigated in CHECKMATE-227 (NCT02477826), a randomized, open-label, multi-part trial in patients with metastatic or recurrent NSCLC and no prior anticancer therapy. In Part 1a of the trial, 793 patients with PD-L1 tumor expression ≥1% were randomized to receive either the combination of nivolumab plus with ipilimumab (n=396) or platinum-doublet chemotherapy (n=397).
The trial demonstrated a statistically significant improvement in overall survival for patients with PD-L1 tumor expression ≥1% receiving nivolumab plus ipilimumab compared to those treated with platinum-doublet chemotherapy. Median OS was 17.1 months (95% CI: 15, 20.1) versus 14.9 (95% CI: 12.7, 16.7) (HR 0.79; 95% CI: 0.67, 0.94; p=0.0066).
Median progression-free survival per blinded independent central review was 5.1 months (95% CI: 4.1, 6.3) in the nivolumab plus ipilimumab arm and 5.6 months (95% CI: 4.6, 5.8) in the platinum-doublet chemotherapy arm (HR 0.82; 95% CI: 0.69, 0.97). Confirmed overall response rate per BICR was 36% (95% CI: 31, 41) and 30% (95% CI: 26, 35), respectively. Median response duration was 23.2 months in the nivolumab plus ipilimumab arm and 6.2 months in the platinum-doublet chemotherapy arm.
