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FDA Grants Bempegaldesleukin Plus Nivolumab Breakthrough Designation in Melanoma

Gina Columbus @ginacolumbusonc
Published: Thursday, Aug 01, 2019

Stephen Doberstein, PhD, SVP

Stephen Doberstein, PhD, SVP

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

The ongoing phase III PIVOT 1O 001 trial is evaluating bempegaldesleukin in combination with nivolumab versus nivolumab alone as frontline therapy for patients with advanced melanoma (NCT03635983).


  1. Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with OPDIVO (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma. Nektar. Published August 1, 2019. Accessed August 1, 2019.
  2. Hurwitz ME, Cho DC, Balar AV, et al. Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab. J Clin Oncol. 2019;37(suppl; abstr 2623). doi: 10.1200/JCO.2019.37.15_suppl.2623.

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