Alkermes' Nemvaleukin Shows Encouraging Anti-Tumor Activity In Pretreated Kidney Cancer

Alkermes plc ALKS presented new data from the ongoing phase 1/2 ARTISTRY-1 trial for nemvaleukin alfa, engineered interleukin-2 (IL-2) variant immunotherapy for advanced renal cell carcinoma (RCC).

• The data were presented at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium.
• The presentation includes updated efficacy and safety data from the monotherapy arm of ARTISTRY-1, in which anti-tumor activity was observed in RCC patients, including patients who were checkpoint inhibitor (CPI)-pretreated.
• Yesterday, the Company reported better than expected Q4 FY21 financial results.
• The ARTISTRY-1 monotherapy RCC cohort included 27 patients with advanced RCC, 56% of whom were CPI-pretreated. 
• Nemvaleukin monotherapy induced robust expansion of CD8+ T and natural killer (NK) cells, with minimal effect on regulatory T cells (Tregs).
• Among 23 evaluable patients, four patients 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.
• Regardless of causality, fever, chills, nausea, and anemia were the most frequently reported adverse events (AEs). There were no deaths due to treatment-related AEs. 
• Price Action: ALKS shares are down 7.05% at $24.90 during the market session on the last check Thursday.