Two Phase III studies of NKTR-214 in combination with Opdivo in melanoma failed (PIVOT IO-001)

Based on data from the ongoing Phase I/II clinical study PIVOT-02 in patients with metastatic (Phase IV) melanoma presented at the 2019 American Society of Clinical Oncology ( ASCO

On March 14, Biomys Squibb and Nektar Therapeutics jointly announced that bempegaldesleukin (NKTR-214) in combination with nivolumab compared with nivolumab alone in previously untreated unresectable or metastatic melanoma.

Bempegaldesleukin (BEMPEG/NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to consist of IL-2 conjugated to an average of six polyethylene glycol (PEG) chains, designed to Provides rapid and sustained signaling by binding to IL-2Rβγ receptors without binding to immune-suppressing regulatory T cell IL-2Rαβγ receptors, selectively stimulating and expanding specific anticancer T cells and natural killer (NK) cells

In addition, based on the results of the independent Data Monitoring Committee (DMC) review of the PIVOT IO-001 study, the companies also decided to discontinue enrollment and unblind the ongoing Phase III PIVOT-12 study in adjuvant melanoma, which is designed to evaluate Adjuvant immunotherapy efficacy of NKTR-214 plus nivolumab versus nivolumab alone after complete resection of melanoma in patients at high risk of recurrence

NKTR-214 was originally developed by Nektar Therapeutics, and Bristol-Myers Squibb signed a cooperative development agreement with a down payment of $1.