Nemvaleukin alfa is under clinical development by Alkermes and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Nemvaleukin alfa’s likelihood of approval (LoA) and phase transition for Head And Neck Cancer Squamous Cell Carcinoma took place on 22 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
In addition, the same event on 22 Nov 2022 increased Nemvaleukin alfa’s LoA and PTSR for Recurrent Head And Neck Cancer Squamous Cell Carcinoma.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Nemvaleukin alfa Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Nemvaleukin alfa overview
Nemvaleukin alfa (ALKS-4230) is under development for the treatment of advanced solid tumors in both refractory and treatment naive patients, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma, bile duct cancer (cholangiocarcinoma), extrahepatic bile duct cancer, cervical cancer, endometrial cancer, adenocarcinoma of the gastroesophageal junction, esophageal cancer, recurrent head and neck squamous cell carcinoma, gastric cancer, melanoma, renal cell carcinoma, urothelial carcinoma and microsatellite instability-high cancers including colorectal cancer, triple-negative breast cancer, ovarian carcinoma, chondrosarcoma, pancreatic cancer, rectal cancer, soft tissue sarcomas, lymphoma and patients with metastatic NSCLC whose tumors express low or undetectable PD-L1. The drug candidate is administered as intravenous infusion and subcutaneous route. It is a new biologic entity based on fusion of IL-2 and its receptors (IL-2 receptor alpha). The transactivation and coordinate expression of IL-2 and IL-2R alpha enhances tumor killing T cells. It is developed using Picasso platform which is a fusion protein technology platform that modulates the natural mechanism of action of a biologic and provides safety and tolerability advantages.
Alkermes is a biopharmaceutical company that focuses on the research, development, and commercialization of drugs for the treatment of cancer, neurodegenerative and central nervous system (CNS) diseases. The company’s proprietary products include Aristada and Aristada Initio an extended-release intramuscular injectable suspension for the treatment of schizophrenia; and Vivitrol, a once-monthly, non-addictive, injectable medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence. It also grants licenses under its proprietary technologies to enable third parties to develop, commercialize and manufacture products. Alkermes sells its products primarily to pharmaceutical wholesalers, treatment providers, specialty distributors and pharmacies. The company has global operations. Alkermes is headquartered in Dublin, Ireland.
Quick View Nemvaleukin alfa LOA Data
|Highest Development Stage|