The Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.
Nemvaleukin alfa is an investigational engineered fusion protein composed of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain. By binding to the intermediate-affinity IL-2 receptor complex, nemvaleukin alfa is expected to selectively expand antitumor activity while avoiding the activation of immunosuppressive cells.
The antitumor activity and safety of nemvaleukin alfa plus pembrolizumab is being investigated in the open-label, randomized, phase 3 ARTISTRY-7 trial (ClinicalTrials.gov: NCT05092360), which is expected to enroll 376 patients with platinum-resistant ovarian cancer. Patients will be randomly assigned 3:1:1:3 to receive either: nemvaleukin plus pembrolizumab; pembrolizumab alone; nemvaleukin alone; or an investigator’s choice of chemotherapy.
“This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options,” said Craig Hopkinson, MD, Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. “We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease.”
The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin alfa for the treatment of mucosal melanoma.
Alkermes receives FDA Fast Track designation for nemvaleukin alfa in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer. News release. Alkermes plc. October 25, 2021. Accessed October 26, 2021. https://www.prnewswire.com/news-releases/alkermes-receives-fda-fast-track-designation-for-nemvaleukin-alfa-in-combination-with-pembrolizumab-for-the-treatment-of-platinum-resistant-ovarian-cancer-301407169.html.