The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to bempegaldesleukin (NKTR-214; Nektar Therapeutics and Bristol-Myers Squibb) in combination with nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with previously untreated unresectable or metastatic melanoma. 

Bempegaldesleukin is an investigational CD122-preferential IL-2 pathway agonist designed to stimulate growth of CD8+ effector T cells and natural killer (NK) cells. The Breakthrough Therapy designation is supported by data from the ongoing PIVOT-02 phase 1/2 study which was recently presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from the cohort of patients (N=38) with metastatic melanoma that were treated with the doublet regimen. 

Results showed at 12.7 months, 53% of patients (N=20) achieved a complete or partial response, with 34% of patients (N=13) achieving complete response; 42% of patients (N=16) achieved a maximum reduction of 100% in target lesions. The median time to response was observed to be 2 months.

Regarding safety, the most common treatment-related adverse events were grade 1-2 fatigue, pyrexia, rash, pruritus, nausea, influenza-like illness, arthralgia, chills and myalgia.

“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,” said Dr Stephen Doberstein, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics. “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.”

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The Company is currently enrolling patients for a phase 3 clinical trial evaluating the efficacy, safety and tolerability of bempegaldesleukin in combination with nivolumab for patients with previously untreated melanoma that is either inoperable or metastatic. 

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