Nektar Therapeutics and Bristol-Myers Squibb were granted Breakthrough Therapy Designation by the U.S. FDA for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. 
 
The Breakthrough Therapy Designation is based on clinical data from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase 1/2 clinical study. A Phase 3 clinical trial evaluating bempegaldesleukin in combination with nivolumab versus nivolumab in first-line advanced melanoma patients is currently recruiting patients.
 
“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,” said Dr. Stephen Doberstein, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics. “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 in this ongoing cohort of melanoma patients.”