FDA Grants Fast Track Designation to Mucosal Melanoma Treatment Nemvaleukin Alfa

The FDA has granted a fast track designation for nemvaleukin alfa, an interleukin-2 variant immunotherapy, for the treatment of mucosal melanoma.

The FDA has granted a fast track designation for nemvaleukin alfa (ALKS 4230), an interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma, according to a press release by Alkermes plc.

Nemvaleukin alfa is a fusion protein consisting of modified IL-2 and the high-affinity IL-2 alpha receptor chain. This combination is designed to expand tumor-destroying immune cells while not activating immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The agent’s selectivity is meant to mitigate limitations while boosting the anti-tumor effects of IL-2 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," said Craig Hopkinson, MD, chief medical officer and executive vice president of research & development at Alkermes in a press release. "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."

Currently, a phase 2 study, ARTISTRY-6 (NCT04830124), is underway to determine the efficacy of the agent as a monotherapy in patients with advanced cutaneous melanoma or advanced mucosal melanoma. The non-randomized, parallel assignment, open-label study has an estimated enrollment of 110 participants and an estimated completion date of September 2025.

The primary end point of the study is overall response rate. Secondary end points include duration of response, progression-free survival, disease control rate, time to response, and treatment-emergent adverse events.

The study has 2 arms. In arm 1, patients with advanced cutaneous melanoma receive an injection of the agent every 7 days. In arm 2, patients with advanced mucosal melanoma receive the study drug as an infusion over 30 minutes given daily for 5 consecutive days.

In order to participate, patients must have received anti-PD-(L)1 therapy, with or without anti-CTLA-4 therapy, and 1 or less other prior regimen of systemic anti-neoplastic therapy. Patients must also have measurable disease based on RECEIST1.1 and an ECOG performance status of 0 or 1. Patients with uveal melanoma, who receive prior IL-2 based or IL-15 based cytokine therapy, who require systemic corticosteroids, undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant, who are currently pregnant or breastfeeding, active central nervous system metastases, or an uncontrollable bleeding disorder are not eligible to participate.

ARTISTRY-6 is currently recruiting in Kentucky and Minnesota. However, a source from Alkermes informed Targeted Oncology that the company is working to expand the study beyond those 2 states.

Earlier in 2021, nemvaleukin alfa was also granted an orphan drug designation. In addition to being studied as a monotherapy, it is also being evaluated in combination with pembrolizumab (Keytruda) in patients with advanced solid tumors.

Alkermes receives FDA fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma. News release. Alkermes. August 2, 2021. https://bit.ly/3xmdaLr.