Bristol Myers Ends Clinical Program for Combination Drug Therapy

Bristol Myers Squibb and Nektar Therapeutics recently ended the global clinical development program for their combination drug therapy, bempegaldesleukin (BEMPEG) and Opdivo (nivolumab), in renal cell carcinoma (RCC) and bladder cancer.

First, the Phase 3 PIVOT-09 study found that the combination treatment did not meet the prespecified boundary for statistical significance compared to the tyrosine kinase inhibitor (TKI) control group in previously untreated advanced or metastatic RCC.

And an interim analysis of overall survival (OS) also did not meet the prespecified boundary for statistical significance in either of these populations. Therefore, the companies unblinded the trial and will not perform additional analyses for the OS endpoint.

Additionally, a separate Phase 2 PIVOT-10 study did not reach an efficacy threshold to support continuing the treatment for patients with cisplatin-ineligible, a locally advanced or metastatic urothelial cancer.

The companies will review the data for both studies and plan to share the results with the scientific community.

All other studies of BEMPEG combined with Opdivo, including a pivotal study in muscle-invasive bladder cancer, a Phase 1/2 study of the doublet in combination with TKI therapy in 1L RCC, and a Phase 1/2 study in recurrent and/or refractory pediatric tumors, will be discontinued.

“As a leader in developing innovative therapies for patients with cancer, we are committed to continuing to explore novel combinations and pathways and advancing research that may help cancer patients achieve better outcomes,” Jonathan Cheng, senior vice president and head of oncology development at Bristol Myers Squibb, said in the announcement.

“We are immensely grateful to the patients and investigators who participated in these studies,” Cheng continued.

Last month, Bristol Myers Squibb and Nektar Therapeutics discontinued two pivotal melanoma studies based on the Phase 3 PIVOT IO-001 study in metastatic melanoma. 

Both studies evaluating BEMPEG combined with Opdivo compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma did meet the primary endpoints of progression-free survival (PFS) or objective response rate (ORR).