- Bristol Myers Squibb Co (NYSE:BMY) and Nektar Therapeutics (NASDAQ: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.
