Policy & Regulation
Alkermes signs clinical trial collaboration and supply agreement with MSD
8 April 2021 -

Ireland-based Alkermes plc (Nasdaq: ALKS) has signed a clinical trial collaboration and supply agreement with United States-based MSD (a tradename of Merck & Co Inc, Kenilworth, NJ, USA) for a planning phase three study to assess nemvaleukin alfa, the company's novel investigational engineered interleukin-2 variant immunotherapy, in combination with MSD's KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer, it was reported on Wednesday.

According to the terms of the contract, Alkermes is responsible for conducting the phase three study that is scheduled to commence in the second half of 2021. The product is an investigational, novel, engineered fusion protein that includes modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, aimed at selectively expanding tumour-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

Jessicca Rege, PhD, vice president, head of Oncology at Alkermes, said, '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 tumour type. 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 tumour type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer.'



Related Headlines