Priority Review Granted by FDA to Immunotherapy Combination in Lung Cancer
Posted: Wednesday, January 22, 2020
On January 15, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration has accepted its supplemental biologics license application for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) in the first-line treatment of patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This application is based on results from Part 1 of the phase III CheckMate 227 study.
In the two-part, open-label CheckMate 227 clinical trial, the combination of nivolumab and ipilimumab versus platinum-doublet chemotherapy was evaluated in patients with previously untreated advanced NSCLC across nonsquamous and squamous tumor histologies. The dual immunotherapy combination demonstrated significant improvement in overall survival over chemotherapy alone. The safety profile of these two agents was consistent with previously reported studies, and no new safety signals were observed.
Part 1a focused on the use of low-dose ipilimumab or nivolumab monotherapy versus chemotherapy in patients whose tumors express PD-L1. Part 1b focused on the use of low-dose ipilimumab or nivolumab plus chemotherapy versus chemotherapy alone in patients whose tumors do not express PD-L1. Part 2 of the trial is evaluating nivolumab plus chemotherapy versus chemotherapy alone, regardless of PD-L1 expression.
Part 1 met both its co-primary endpoints of progression-free survival with the immunotherapy combination versus chemotherapy in patients whose tumors have a high (≥ 10 mutations/megabase) tumor mutation burden, regardless of PD-L1 expression and of overall survival, demonstrating a benefit with nivolumab plus low-dose ipilimumab versus chemotherapy in the first-line treatment of patients NSCLC whose tumors express PD-L1 ≥ 1%. Part 2 did not meet its primary endpoint of overall survival for nivolumab plus chemotherapy versus chemotherapy alone in patients with nonsquamous NSCLC.