Zolbetuximab is under clinical development by Astellas Pharma and currently in Phase II for Metastatic Adenocarcinoma of The Pancreas. According to GlobalData, Phase II drugs for Metastatic Adenocarcinoma of The Pancreas have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Zolbetuximab’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.
Zolbetuximab overview
Zolbetuximab (Vyloy) is a monoclonal antibody (mAb), a genetical recombination. It is formulated as powder for solution for administration as intravenous infusion. Vyloy is indicated for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
Zolbetuximab (claudiximab, IMAB-362) is under development for the treatment of advanced adenocarcinoma of the Gastroesophageal Junction, gastric cancer, esophageal adenocarcinoma and metastatic pancreatic adenocarcinoma. The drug candidate is administered as an intravenous infusion. It is an Ig1 iMAB acts by targeting splice variant of claudin 18 target (claudin 18.2). It is developed based on ideal monoclonal antibody (IMABS) therapeutics. It was under development for the treatment of solid tumors including ovarian cancer and lung cancer.
Astellas Pharma overview
Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, cancer, nephrology, infectious diseases, and metabolic diseases, immunodeficiency, and transplantation. The company strives to develop new drugs to address high unmet medical needs with focus on biology and modality. Its pipeline consists of drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Chuo-Ku, Tokyo, Japan.
For a complete picture of Zolbetuximab’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
