Bristol Myers, Nektar Melanoma Doublet Therapy Trial Fails To Show Clinical Benefit

Bristol Myers Squibb Co BMY and Nektar Therapeutics NKTR have an update following the first analysis of the Phase 3 PIVOT IO-001 study of bempegaldesleukin combined with Opdivo (nivolumab) in previously untreated unresectable or metastatic melanoma patients.
The review by an independent Data Monitoring Committee (DMC) suggested that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR).
The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance.
The companies have decided to unblind the trial and perform no additional analyses for the OS endpoint.
The companies have decided to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma, which evaluates bempegaldesleukin plus Opdivo compared to Opdivo in high-risk patients for recurrence after complete resection of melanoma.
The other four studies ongoing for bempegaldesleukin plus Opdivo in renal cell carcinoma and bladder cancer are continuing, with initial results expected in 1H of 2022.
Price Action: NKTR shares are down 56.1% at $4.67, and BMY stock is up 1.34% at $69.80 during the market session on the last check Monday.