December 6, 2022

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FDA grants Nemvaleukin fast track designation for melanoma

FDA grants Nemvaleukin fast track designation for melanoma

FDA grants Nemvaleukin fast track designation for melanoma.  Nemvaleukin is an engineered interleukin-2 (IL-2) variant immunotherapy.

Mucosal melanoma is a subtype of melanoma. The incidence is related to race. The incidence of colored people is significantly higher than that of whites (approximately 20% and 1% of all melanomas). The main parts of the disease include: head and neck (nasal cavity, sinuses, nasopharynx and other parts), digestive tract (esophagus, rectum, anal canal, etc.) and genitourinary tract (vagina, cervix, urethra, etc.).

Alkermes announced that the FDA has granted Nemvaleukin alfa (Nemvaleukin) fast track designation for the treatment of mucosal melanoma patients who have previously received anti-PD-L1 therapy.

Nemvaleukin is an engineered interleukin-2 (IL-2) variant immunotherapy, which has been awarded the title of orphan drug for the treatment of mucosal melanoma. Recruitment for the global Phase 2 ARTISTRY-6 (NCT04830124) trial has begun, which will study the anti-tumor activity, safety and tolerability of Nemvaleukin alfa in mucosal melanoma patients who have previously received anti-PD-L1 therapy.

Dr. Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research and Development of Alkermes, said: “The fast track qualification of Nemvaleukin for the treatment of mucosal melanoma is an important milestone in the development of this drug, showing the potential clinical utility of Nemvaleukin in the treatment of mucosal melanoma.”

The trial is currently still recruiting and plans to recruit 110 patients. In this non-randomized parallel trial, patients with cutaneous melanoma received Nemvaleukin subcutaneously every 7 days, while patients with mucosal melanoma received intravenous Nemvaleukin 30 minutes a day for 5 days.

The primary endpoint of this study is the overall response rate 2 years after the first medication. The secondary endpoints are duration of remission, progression-free survival, and disease control rate.

Hopkinson said: “We are committed to advancing this important research on mucosal melanoma. Mucosal melanoma is a rare and aggressive melanoma with very limited treatment options, especially for patients previously treated with checkpoint inhibitors. “

The ARTISTRY trial is evaluating the application of Nemvaleukin as a single agent and combination therapy in some tumor types. For example, researchers are currently using intravenous and subcutaneous doses of Nemvaleukin in combination with anti-PD-1 therapy pembrolizumab (pembrolizumab, Keytruda) to treat patients with solid tumors.

Let us look forward to the good news from clinical trials as soon as possible and bring hope to more patients.

(source:internet, reference only)


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