Dostarlimab is under clinical development by GSK and currently in Phase III for Colon Cancer. According to GlobalData, Phase III drugs for Colon Cancer have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Dostarlimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
Dostarlimab overview
Dostarlimab (Jemperli) is a immunoglobulin G4 humanized monoclonal antibody, acts as anti neoplastic agent. It is formulated as solution and concentrate solution for intravenous route of administration. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
Dostarlimab is under development for the treatment of solid tumors including high-grade neuroendocrine carcinoma, advanced small cell lung cancer, triple negative breast cancer, colorectal cancer, metastatic pancreatic ductal adenocarcinoma, recurrent and metastatic head and neck squamous cell carcinoma, laryngeal cancer, hypopharyngeal cancer, oropharyngeal cancer, oral cavity cancer squamous and non-squamous non-small cell lung carcinoma, malignant pleural mesothelioma, cervical cancer, rectal adenocarcinoma, acral melanoma, metastatic microsatellite instability high (MSI-H) endometrial cancer, epithelial ovarian cancer, peritoneal cancer, gestational trophoblastic neoplasia (GTN), fallopian tube cancer, adrenocortical carcinoma, neuroendocrine carcinoma, pancreatic adenocarcinoma, duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma, soft tissue sarcoma, ampulla of Vater adenocarcinoma, penile cancer, vaginal cancer, vulvar cancer who have progressed following one or two prior chemotherapy treatments and first line/second line non-small cell lung cancer and pan-deficient mismatch repair tumors (PdMMRT) (solid tumor), colon cancer. It is administered intravenously. It is an anti-PD-1 mAb. The drug candidate acts by targeting the PD-1 which has the potential to activate anti-tumor immunity. The drug candidate is developed based on somatic hypermutation (SHM) technology platform (SHM-XEL platform).
It was under development for the treatment of metastatic clear cell sarcoma, refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, ewing sarcoma, rhabdomyosarcoma, metastatic urothelial bladder cancer, gastric cancer, adenocarcinoma of the gastroesophageal junction, head and neck cancer, biliary tract cancer, clear cell renal cell carcinoma.
GSK overview
GSK is a healthcare company that focuses on developing, manufacturing and commercializing general medicines, specialty medicines and vaccines. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular, and urogenital, anti-bacterial, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastrointestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.
For a complete picture of Dostarlimab’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.
