Bempegaldesleukin With Nivolumab Granted Breakthrough Therapy Designation in Melanoma
Posted: Monday, August 5, 2019
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for the investigational agent bempegaldesleukin (NKTR-214) in combination with nivolumab for the treatment of patients with previously untreated unresectable or metastatic melanoma. The designation is based on datarecently reported at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract 2623) from a cohort of patients with metastatic melanoma who were treated with the doublet therapy in the ongoing PIVOT-02 phase I/II clinical study.
Bempegaldesleukin is an investigational CD122-preferential interleukin 2–pathway agonist designed to provide activation and proliferation of CD8-positive effector T cells and natural killer cells. A phase III clinical trial (ClinicalTrials.gov identifier NCT03635983) evaluating first-line bempegaldesleukin in combination with nivolumab vs nivolumab in advanced melanoma is currently recruiting patients.