'Breakthrough' status for bempegaldesleukin combo with Opdivo

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for investigational agent bempegaldesleukin (NKTR-214), from Nektar Therapeutics (Nasdaq: NKTR), in combination with Bristol-Myers Squibb's (NYSE: BMY) Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.

Nektar’s shares were up 4.5% at $29.75 pre-market following release of the news.

The designation is based on clinical data which was recently reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase I/II clinical study.