- Nektar Therapeutics (NASDAQ:NKTR) and Bristol Myers Squibb Co (NYSE:BMY) have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.
- The decision follows the results from pre-planned analyses of two late-stage studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer.
- A preplanned interim analysis found that the investigational combination failed to improve on the overall survival achieved by the TKIs in either population.
- Given that there was no clinical benefit in the doublet therapy arm compared to the TKI arm, the companies have decided to unblind the trial and perform no additional analyses for the OS endpoint.
- Related: Bristol Myers, Nektar Melanoma Doublet Therapy Trial Fails To Show Clinical Benefit
- In another Phase 2 PIVOT-10 study of the bempegaldesleukin / Opdivo doublet in cisplatin-ineligible, locally advanced, or metastatic urothelial cancer patients, a final ORR analysis showed that the combo therapy did not reach an efficacy threshold.
- These studies and all other ongoing studies in the program will be discontinued.
- The studies now winding down include a pivotal program in muscle-invasive bladder cancer and a pair of phase 1/2 trials in RCC and pediatric tumors.
- In 2018, the companies established a broad joint clinical development plan combining NKTR-214 with Opdivo and Opdivo plus Yervoy (ipilimumab) in registration-enabling trials in more than 20 indications across nine tumors.
- Price Action: NKTR shares are 33.9% lower at $4.07 premarket on the last check Monday.
