Alkermes Presents New Nemvaleukin Alfa Monotherapy Data at the American Society of Clinical Oncology Genitourinary Cancers Symposium

- Data From ARTISTRY-1 Clinical Trial Highlight Single-Agent, Anti-Tumor Activity of Nemvaleukin in Patients With Renal Cell Carcinoma - 

DUBLIN, Feb. 17, 2022 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today presented new data from the ongoing phase 1/2 ARTISTRY-1 clinical trial for nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy. The data were presented at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place Feb. 17-19, 2022.

The presentation includes updated efficacy and safety data from the monotherapy arm of ARTISTRY-1, in which single-agent, anti-tumor activity of intravenous (IV) nemvaleukin was observed in patients with advanced renal cell carcinoma (RCC), including patients who were checkpoint inhibitor (CPI)-pretreated.

"Nemvaleukin's single-agent activity is an important differentiating feature in the IL-2 space and suggests that nemvaleukin may contribute clinical benefit when used in combination regimens with other cancer treatments like checkpoint inhibitors," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Together with the objective responses previously reported in the melanoma cohort of this study, these data in renal cell carcinoma show nemvaleukin's monotherapy activity in two tumor types where high-dose IL-2 is approved, thus validating its novel molecular design."

Data highlights from the ASCO GU poster presentation include:

ARTISTRY-1, IV Nemvaleukin (6 μg/kg) Monotherapy Arm, RCC Patients
The ARTISTRY-1 monotherapy RCC cohort included 27 patients with advanced RCC, 56% of whom were CPI-pretreated. As of the Oct. 29, 2021 data cutoff:

• Nemvaleukin monotherapy induced robust expansion of CD8⁺ T and natural killer (NK) cells, with minimal effect on regulatory T cells (T_regs).
• Among 23 evaluable patients (with at least one post-baseline scan):
• Four patients, all of whom were CPI-pretreated, achieved a partial response (one unconfirmed) and three of these patients continued on monotherapy.
• Decreases in target lesions of up to 60% were observed.
• Stable disease was observed in 10 patients.

Safety among these patients with advanced RCC was consistent with that which was previously reported for the IV nemvaleukin monotherapy-treated population in the ARTISTRY-1 study. Fever, chills, nausea and anemia were the most frequently reported adverse events (AEs), regardless of causality. Chills and anemia were the most commonly reported treatment-related AEs of grade ≥3. There were no deaths due to treatment-related AEs.