Dostarlimab is under clinical development by GSK and currently in the Phase I, 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 Dostarlimab’s likelihood of approval (LoA) and phase transition for Metastatic Biliary Tract Cancer took place on 05 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Dostarlimab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 gastric cancer, high-grade neuroendocrine carcinoma, advanced small cell lung cancer, adenocarcinoma of the gastroesophageal junction, head and neck cancer, biliary tract cancer, clear cell renal cell carcinoma, metastatic urothelial bladder cancer, triple negative breast cancer, refractory osteosarcoma, colorectal cancer, neuroblastoma, adrenocortical carcinoma, ewing sarcoma, rhabdomyosarcoma, metastatic pancreatic ductal adenocarcinoma, recurrent and metastatic head and neck squamous cell carcinoma, squamous non-small cell lung cancer, malignant pleural mesothelioma, cervical cancer, rectal adenocarcinoma, acral melanoma, metastatic microsatellite instability high (MSI-H) endometrial cancer, epithelial ovarian cancer, metastatic clear cell sarcoma, peritoneal cancer, gestational trophoblastic neoplasia (GTN), fallopian tube cancer, penile 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). 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).

GSK overview

GSK is a healthcare company that focuses on developing, manufacturing and commercializing pharmaceuticals, vaccines and consumer healthcare products. 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-bacterials, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastro-intestinal 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.

Quick View Dostarlimab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dostarlimab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: GSK
  • Originator: AnaptysBio
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.