On February 17, 2022 Alkermes plc (Nasdaq: ALKS) reported that 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 (Press release, Alkermes, FEB 17, 2022, View Source [SID1234608217]). The data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place Feb. 17-19, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (Free ASCO Whitepaper) 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 (Tregs).
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.

Details of the presentation are available on the ASCO (Free ASCO Whitepaper) GU website at View Source

Abstract: 330
Title: Nemvaleukin Alfa in Patients With Advanced Renal Cell Carcinoma: ARTISTRY-1
Presenter: Emiliano Calvo, M.D., Ph.D., Medical Oncologist and Director of Clinical Research at the START Madrid-Centro Integral Oncológico Clara Campal Hospital, Madrid, Spain
Presentation Date: The poster, along with a pre-recorded presentation, will be available on the ASCO (Free ASCO Whitepaper) GU virtual meeting platform beginning Feb. 17, 2022.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.