Disitamab vedotin is under clinical development by Pfizer and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Disitamab vedotin’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.
Disitamab vedotin overview
Disitamab vedotin (Aidexi) is an antibody-conjugated drug that contains the human epidermal growth factor receptor-2 (HER2) antibody portion, linker and the cytotoxic drug monomethyl auristatin E (MMAE). It is developed based on antibody-drug conjugates technology. It is formulated as solution for injection for intravenous route of administration. Aidexi is indicated for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 over-expression in patients who have received at least two types of systemic chemotherapy.
Disitamab vedotin (RC-48) is under development for the treatment of solid tumors including breast cancer, HER2 expressing non-small cell lung cancer, non-muscle invasive bladder cancer (NMIBC), metastatic liver cancer, advanced or metastatic urothelial carcinoma of unresectable origin including urothelial carcinoma of bladder, ureter cancer, renal pelvis cancer, and urethral cancer, advanced melanoma, advanced or metastatic HER2 expressing biliary tract cancer, bile duct cancer, gallbladder cancer, muscle invasive bladder cancer (MIBC), HER2 expressing urothelial carcinoma and HER2 low to non expressing urothelial cancer, metastatic cholangiocarcinoma, HER2 expressing gastric cancer, gastro-esophageal junction cancer or gastroesophageal junction adenocarcinoma and refractory HER2 low expressing metastatic breast cancer, HER2 positive and negative breast cancers, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, endometrial cancer, vulvar cancer, vaginal cancer, metastatic colorectal cancer, salivary gland tumor, head and neck squamous cell carcinoma, esophageal carcinoma, metastatic castration resistant prostate cancer (mCRPC), oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer and primary sarcoma of the gynecological reproductive system. It is a recombinant humanized anti-HER2 monoclonal antibody-monomethyl auristatin E (MMAE) antibody-drug conjugate administered through intravenous and intravenous drip routes in the form of powder for solution. The drug candidate acts by targeting the human epidermal growth factor receptor 2 (Her2). The drug candidate is developed based on antibody-drug conjugates technology. It was also under development for the treatment of ovarian cancer and bladder cancer
Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, women’s health, cancer, inflammation, immune disorders, and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, individual provider offices, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East. Pfizer is headquartered in New York, the US.
For a complete picture of Disitamab vedotin’s drug-specific PTSR and LoA scores, buy the report here.