Nemvaleukin Achieves FDA Expedited Designation for Platinum-Resistant Ovarian Cancer
The accelerated designation was granted by the FDA to the experimental engineer of the interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (formerly ALKS 4230), for use in combination with pembrolizumab (Keytruda ) as a treatment for patients with platinum resistant ovaries. cancer, according to a press release from Alkemes plc.1
Nemvaleukin has been designed to increase tumor-killing immune cells and limit activation of immunosuppressive cells to promote anti-tumor activity. The agent will be studied in the ARTISTRY-7 Phase 3 clinical trial (NCT05092360).
“This accelerated 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 remains. a significant need for new treatment options, ”said Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes. “We are delighted to launch our planned Phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin to potential registration and seek to help patients living with this disease. “
In the multicenter, open-label, randomized study, approximately 376 patients with platinum-resistant epithelial cancer of the ovary, fallopian tubes or primary peritoneum will be recruited and assigned 3: 1: 1: 3 to receive nemvaleukin ether 6 µg / kg / day in combination with pembrolizumab 200 mg in arm 1, pembrolizumab alone in arm 2, nemvaleukin alone in arm 3, or chemotherapy at the choice of the investigator in arm 4.2
In the experimental arms, nemvaleukin will be administered on days 1 to 5 of the 21-day cycles by infusion (IV). Pembrolizumab is given on day 1 of the 21-day cycles, also by IV infusion. In the control arm, chemotherapy options include pegylated liposomal doxorubicin 40 mg / m2 given on day 1 of 28-day cycles, paclitaxel 80 mg / m2 given on days 1, 8, 15 and 22 of the 28-day cycles, topotecan 4 mg / m2 given on days 1, 8 and 15 of the 28-day cycles, or gemcitabine 1000 mg / m2 administered on days 1 and 2 of the 21-day cycles. All chemotherapy is given by IV infusion in the study.
ARTISTRY-7 primarily studies progression-free survival with nemvaleukin in combination with pembrolizumab, nemvaleukin monotherapy, and pembrolizumab monotherapy versus chemotherapy in patients with platinum-resistant ovarian cancer. Secondary endpoints explored in the study included objective response rate, overall survival rate, disease control rate, duration of response, time to response, response to drug antigen. cancer 125 and the incidence of treatment-related adverse events.
Patients eligible for inclusion in the study are those aged 18 years or older with histologically confirmed disease that is platinum resistant or refractory and who have received at least 1 prior line of systemic cancer therapy as part of platinum sensitivity. Patients cannot have received more than 5 previous lines of treatment and must also have measurable disease according to RECIST v1.1 and be ready for tumor biopsy.
The study excludes people with primary platinum-refractory disease or primary platinum resistance or disease progression less than 3 months after the end of first-line treatment. Patients with histologically confirmed epithelial ovarian cancer with a mucinous subtype or carcinosarcoma are not eligible for the study, as are those with a non-epithelial tumor. Tumor with low malignant potential, requiring fluid drainage of 500 ml or more within 6 weeks of the first study dose, previously treated with an IL-2 agent or previously exposed to an anti-PD-1 / PD- Therapy L1.
Previously, nemvaleukin had obtained accelerated and orphan drug designations from the FDA for the treatment of patients with mucosal melanoma. With an accelerated designation for platinum resistant ovarian cancer, the development of the agent in this disease state will be accelerated to potentially meet an unmet medical need.1
1. Alkermes receives FDA expedited designation for nemvaleukin alfa in combination with pembrolizumab for the treatment of platinum resistant ovarian cancer. Press release. October 25, 2021. Accessed October 25, 2021. https://bit.ly/3ma7Acz
2. Phase 3 study of nemvaleukin alfa in combination with pembrolizumab (ARTISTRY-7). Clinicaltrials.gov. Accessed October 25, 2021. https://bit.ly/3mdQmek