Nektar and Bristol Myers Squibb Announce Update on Clinical Development Program for Bempegaldesleukinin Combination with Opdivo

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Nektar Therapeutics and Bristol Myers Squibb, on Thursday, announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer.

The companies have jointly decided to end the global clinical development program for ‘bempegaldesleukin’ in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued.

“We thank BMS for their collaboration on the studies of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune disease.”

Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics

In the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk or all-risk populations, the Phase 3 PIVOT-09 study found that bempegaldesleukin in combination with Opdivo did not meet the prespecified boundary for statistical significance in comparison to the tyrosine kinase inhibitor (TKI) control arm in patients with previously untreated advanced or metastatic RCC.

In a separate Phase 2 PIVOT-10 study of the bempegaldesleukin/Opdivo doublet in patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer, a final ORR analysis assessed by BICR revealed that bempegaldesleukin in combination with Opdivo did not reach an efficacy threshold to support the program’s continuation in urothelial carcinoma.

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

Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb

Both experiments’ data will be reviewed by the firms, and the results will be shared with the scientific community. All other studies of bempegaldesleukin in combination with Opdivo will be stopped allowing patients and their doctors to consider standard of care treatment options for their specific conditions.

Based on the results of the Phase 3 PIVOT IO-001 study in metastatic melanoma, the firms had stated in March that two key melanoma studies will be stopped. The firms will collaborate in the coming months to end the clinical trial for bempegaldesleukin in conjunction with Opdivo.

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