Nemvaleukin alfa is under clinical development by Alkermes and currently in Phase II for Gallbladder Cancer. According to GlobalData, Phase II drugs for Gallbladder Cancer have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Nemvaleukin alfa’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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.
For a complete picture of Nemvaleukin alfa’s drug-specific PTSR and LoA scores, buy the report here.