Global Clinical Development Program for Bempegaldesleukin in Combination With Nivolumab Will Be Discontinued

The companies have decided to unblind the trial and perform no additional analyses for the OS endpoint because there was no clinical benefit observed in the doublet therapy arm.

Following the results from pre-planned analyses of 2 late-stage clinical studies of bempegaldesleukin (Bempeg) in combination with nivolumab (Opdivo) in renal cell carcinoma (RCC) and bladder cancer, Nektar Therapeutics and Bristol Myers Squibb announced these studies and other ongoing studies surrounding these drugs will be discontinued.

For the phase 3 PIVOT-09 study in patients with previously untreated advanced or metastatic RCC, an independent Data Monitoring Committee informed Nektar and Bristol Myers Squibb that a final analysis of objective response rate (ORR) showed that bempegaldesleukin in combination with nivolumab did not meet the prespecified boundary for statistical significance in comparison to the tyrosine kinase inhibitor control arm. Further, an interim analysis of overall survival (OS) did not meet the prespecified boundary for statistical significance in either of these populations.

The companies have decided to unblind the trial and perform no additional analyses for the OS endpoint because there was no clinical benefit observed in the doublet therapy arm.

Meanwhile, in a separate phase 2 PIVOT-10 study of the bempegaldesleukin/nivolumab doublet in patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer, a final analysis showed that bempegaldesleukin in combination with nivolumab did not reach an efficacy threshold to support continuing the program in urothelial carcinoma.

All other studies of bempegaldesleukin in combination with nivolumab will be discontinued, including a pivotal study in muscle-invasive bladder cancer (CA045-009), a phase 1/2 study of the doublet in combination with TKI therapy in 1L RCC (CA045-011), and a phase 1/2 study in recurrent and/or refractory pediatric tumors (CA045-020).

“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,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb, in a press release. “We are immensely grateful to the patients and investigators who participated in these studies.”

REFERENCE

Nektar and Bristol Myers Squibb Announce Update on Clinical Development Program for Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab). April 14, 2022. Accessed April 15, 2022. https://news.bms.com/news/corporate-financial/2022/Nektar-and-Bristol-Myers-Squibb-Announce-Update-on-Clinical-Development-Program-for-Bempegaldesleukin-BEMPEG-in-Combination-with-Opdivo-nivolumab/default.aspx