On April 7, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), Alkermes’ novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with MSD’s KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer (Press release, Alkermes, APR 7, 2021, View Source [SID1234577695]). Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.
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"We are pleased to collaborate with MSD to evaluate nemvaleukin in combination with KEYTRUDA in patients with platinum-resistant ovarian cancer, a patient population for which there are limited treatment options available and overall survival remains low. Importantly, there are no anti-PD-1 treatments currently approved for this tumor type," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "Nemvaleukin in combination with KEYTRUDA has demonstrated antitumor activity in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study, with durable and deepening responses observed. We look forward to initiating this phase 3 study to further evaluate the potential clinical utility of this combination in this tumor type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer."
About nemvaleukin alfa
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 selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.
About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin in patients with advanced solid tumors.
ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days, followed by an off-treatment period. In the ongoing phase 2 efficacy expansion stage of ARTISTRY-2, nemvaleukin is administered subcutaneously once every seven days.
ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of intravenous nemvaleukin monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.