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The Phase III study will evaluate nemvaleukin alfa, Alkermes' novel investigational engineered interleukin-2 variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in patients with platinum-resistant ovarian cancer.
Merck, known as MSD outside of the United States and Canada, and Alkermes, a biopharmaceutical company headquartered in Ireland, announced on April 7, 2021 that they have entered into a collaboration and supply agreement to conduct a Phase III study to evaluate nemvaleukin alfa, Alkermes' novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in patients with platinum-resistant ovarian cancer.
The combination is currently being evaluated in two 1/2 phase studies, ARTISTRY-1 and ARTISTRY-2, to determine its safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic effects, Alkermes said in a company press release.
"We are pleased to collaborate with [Merck] 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, PhD, 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 III 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."