Bempegaldesleukin Plus Nivolumab Granted Breakthrough Designation in Melanoma by the FDA

Source: Targeted Oncology, September 2019

The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.

The combination of  bempegaldesleukin and nivolumab led to an overall response rate (ORR) of 53% by independent radiology review, which included a 34% complete response (CR) rate, in this patient population in a cohort of the ongoing phase I/II PIVOT-02 trial, which is the basis for the FDA deisgination.

“In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients,” Stephen Doberstein, PhD, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics, stated in a press release. “Our teams are encouraged by the deepening of responses we observed in patients with previously untreated advanced melanoma who received the doublet therapy in our PIVOT-02 study. We look forward to continuing to provide updated results at a future medical meeting as the data mature further from this ongoing cohort of melanoma patients.”