Nektar decimated as Phase III trial of BEMPEG in combo with Opdivo misses goal

14 March 2022

Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (Nasdaq: NKTR) today announced disappointing results from their Phase III PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma.

Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers 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). The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.

Following the revelation, Nektar’s shares plunged 58.6% to $4.46 in morning trading.

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