Alkermes (ALKS) will have a solid presence at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually June 4-8, 2021, explains John McCamant, biotech sector specialist and editor of The Medical Technology Stock Letter.
The company will present two abstracts related to nemvaleukin alfa (nemvaleukin), the company’s novel interleukin-2 (IL-2) variant immunotherapy, and new data from the Phase 1/2 ARTISTRY-1 clinical trial evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA) will be shared in a poster discussion session.
In addition, data supporting the recommended Phase 2 dose (RP2D) for nemvaleukin administered subcutaneously from the Phase 1/2 ARTISTRY-2 clinical trial will be shared in a separate poster.
ALKS also announced the initiation of ARTISTRY-6, a global Phase II (110 patients) trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin alfa (nemvaleukin) monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy.
The study will evaluate intravenously administered (IV) nemvaleukin in patients with mucosal melanoma and subcutaneously administered (SC) nemvaleukin in patients with advanced cutaneous melanoma. Nemvaleukin was granted Orphan Drug designation for the treatment of mucosal melanoma by the FDA in March 2021.
In April 2021, the company entered into a clinical trial collaboration and supply agreement with PDL-I leader Merck for a Phase III trial to evaluate nemvaleukin in combination with KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer.
The study is planned to initiate in the second half of 2021. ALKS is doing a good job of positioning nemvaleukin for value creation with both monotherapy trials, ARTISTRY-6 and the upcoming Phase III combo trial with Merck’s Keytruda. In our view, the details of the upcoming ASCO abstracts could serve a s a strong catalyst for the stock.
The next big event for ALKS is the potential FDA approval for LYBALVI. The company continues to prepare for a potential 2021 launch ahead of the June 1st PDUFA date and noted that they continue to have label discussions with the FDA.
ALKS reiterated guidance of a second half 2021 launch of the drug. In our view, the recent de-scheduling of the drug by the DEA is a significant positive and de-risks the upcoming PDUFA.