Alkermes has initiated a global Phase II ARTISTRY-6 trial of its lead immuno-oncology candidate nemvaleukin alfa in melanoma patients who have previously received anti-PD-(L)1 therapy.
Nemvaleukin is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy.
ARTISTRY-6 will assess the anti-tumour activity, safety and tolerability of intravenous (IV) nemvaleukin in mucosal melanoma patients.
To establish monotherapy proof-of-concept with subcutaneous (SC) dosing, the trial will also analyse SC nemvaleukin in a cohort of advanced cutaneous melanoma patients.
The trial will have around 110 subjects who will be enrolled into one of two cohorts.
Advanced mucosal melanoma patients will be given 6µg/kg/day IV nemvaleukin for five days every three weeks, while those with advanced cutaneous melanoma will receive 3mg SC nemvaleukin once every seven days.
The centrally-assessed overall response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will form the trial’s primary endpoint with evaluation to be carried out separately for patients with mucosal or cutaneous melanoma.
Safety and tolerability, duration of response, progression-free survival, disease control rate and time to response based on RECIST 1.1, will form the secondary endpoints.
Furthermore, IV and SC nemvaleukin monotherapy’s effects on health-related quality of life, and pharmacokinetic and pharmacodynamics will be evaluated in the study.
Alkermes chief medical officer and executive vice-president Craig Hopkinson said: “The initiation of the ARTISTRY-6 study represents a significant milestone in the nemvaleukin development programme, building on the early signals of anti-tumour activity observed with IV nemvaleukin in melanoma.
“Consistent with our strategy to study nemvaleukin in difficult-to-treat cancers with clear unmet need, we look forward to further evaluating the potential clinical utility of nemvaleukin monotherapy in mucosal melanoma, a rare and aggressive form of melanoma that has very limited treatment options.”
Last month, the US Food and Drug Administration granted orphan drug designation to nemvaleukin for treating mucosal melanoma.