FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma


Immunotherapy agent nemvaleukin alfa was granted an FDA fast track designation for the treatment of patient’s mucosal melanoma for previously undergone treatment with an anti-PD-L1 therapy.

Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.1

Nemvaleukin is an engineered interleukin-2 (IL-2) variant immunotherapy that was previously granted for orphan drug designation for mucosal melanoma.2 Additionally, enrollment has begun for the global phase 2 ARTISTRY-6 (NCT04830124) trial, which will investigate the anti-tumor activity, safety, and tolerability of nemvaleukin alfa in patients with mucosal melanoma that have previously undergone treatment with anti-PD-L1 therapy.

"Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin’s potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, said in a press release.

Investigators plan to enroll approximately 110 patients on ARTISTRY-6 trial , which is still currently recruiting. In this a non-randomized parallel assessment, patients with cutaneous melanoma with be treated with nemvaleukin subcutaneously every 7 days, and patients with mucosal melanoma with be treated with nemvaleukin intravenously for 30 minutes for 5 consecutive days.

The primary outcomes of this study are overall response rate assessed from 2 years after the first dose. Secondary end points are duration of response, progression-free survival, and disease control rate.

"We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors,” Hopkinson said.

A number of ARTISTRY trials are evaluating nemvaleukin both as a single agent and combination regimen across a number of tumor types. For example, investigators are currently using intravenous and subcutaneous doses of nemvaleukin in combination with anti–PD-1 therapy pembrolizumab (Keytruda) for patients with solid tumors.


1. Alkermes receives FDA fast track designation for nemvaleukin alfa for the treat of mucosal melanoma. News Release. Alkermes. August 2, 2021. Accessed August 2, 2021. https://bit.ly/2V6rAm1

2. Alkermes announces FDA orphan drug designation for nemvaleukin alfa for treatment of mucosal melanoma. News Release. Alkermes. March 11, 2021. Accessed August 2, 2021. https://bit.ly/3C5f2M5

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