FDA News

FDA grants breakthrough therapy designation to NKTR-214 in combination with Opdivo for advanced melanoma

The FDA granted breakthrough therapy designation to bempegaldesleukin in combination with nivolumab for initial treatment of unresectable or metastatic melanoma.

Bempegaldesleukin (NKTR-214, Nektar Therapeutics) is an investigational CD122-preferential IL-2 pathway agonist. Nivolumab (Opdivo, Bristol-Myers Squibb) is a PD-1 immune checkpoint inhibitor that is approved in the United States for treatment of several cancers, including certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma or urothelial carcinoma.

The FDA based the breakthrough designation on results from a cohort of patients with metastatic melanoma who received the doublet therapy in the ongoing phase 1/phase 2 PIVOT-02 trial, results of which were presented at this year’s ASCO Annual Meeting.

“In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients,” Stephen Doberstein, senior vice president for research and development and chief research and development officer at Nektar Therapeutics, said in a company-issued press release. “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. We look forward to continuing to provide updated results at a future medical meeting as the data mature further from this ongoing cohort of [patients with melanoma].”

Enrollment is underway for a phase 3 trial to evaluate the bempegaldesleukin-nivolumab combination as first-line treatment of advanced melanoma.

The FDA granted breakthrough therapy designation to bempegaldesleukin in combination with nivolumab for initial treatment of unresectable or metastatic melanoma.

Bempegaldesleukin (NKTR-214, Nektar Therapeutics) is an investigational CD122-preferential IL-2 pathway agonist. Nivolumab (Opdivo, Bristol-Myers Squibb) is a PD-1 immune checkpoint inhibitor that is approved in the United States for treatment of several cancers, including certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma or urothelial carcinoma.

The FDA based the breakthrough designation on results from a cohort of patients with metastatic melanoma who received the doublet therapy in the ongoing phase 1/phase 2 PIVOT-02 trial, results of which were presented at this year’s ASCO Annual Meeting.

“In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients,” Stephen Doberstein, senior vice president for research and development and chief research and development officer at Nektar Therapeutics, said in a company-issued press release. “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. We look forward to continuing to provide updated results at a future medical meeting as the data mature further from this ongoing cohort of [patients with melanoma].”

Enrollment is underway for a phase 3 trial to evaluate the bempegaldesleukin-nivolumab combination as first-line treatment of advanced melanoma.

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