CLINICAL AND REGULATORY
Combination of Bempeg and Opdivo failed in Phase 3 melanoma trial
BMS and Nektar Therapeutics announced 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. Following a review of the study for efficacy and safety by an independent Data Monitoring Committee, BMS and Nektar were informed that the study did not meet the primary endpoints of PFS and ORR as assessed by Blinded Independent Central Review.
The DMC notified the companies that the third primary endpoint of 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, which is evaluating the doublet therapy of bempeg in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma. Patients in both studies will be counseled on their treatment options, and permitted to continue treatment if agreed to with their physician. The companies will review the data and plan to share the results with the scientific community. The other four studies ongoing for bempegaldesleukin plus Opdivo in renal cell carcinoma and bladder cancer are continuing.