Bristol Myers Squibb, Nektar Say Phase 3 PIVOT IO-001 Trial Fails To Meet Endpoints

(RTTNews) - Bristol Myers Squibb (BMY) and Nektar Therapeutics (NKTR) announced Monday an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma.

Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). This followed a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC).

The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.

Given there was no additional clinical benefit in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint.

Additionally, based on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma.