Sintilimab is under clinical development by Eli Lilly and Co and currently in Phase I for Small-Cell Lung Cancer. According to GlobalData, Phase I drugs for Small-Cell Lung Cancer have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sintilimab’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.

Sintilimab overview

Sintilimab (Tyvyt) is a monoclonal antibody which acts as an anti-neoplastic agent. It is formulated solution for intravenous route of administration. Tyvyt is indicated for the treatment of patients with classical hodgkin’s lymphoma (cHL) that has relapsed or refractory after two or more lines of systemic chemotherapy. It is also indicated in combination of pemetrexed and platinum-based chemotherapy for first-line EGFR or ALK-negative advanced non-squamous NSCLC treatment, combination with gemcitabine and platinum-based chemotherapy is suitable for locally advanced or metastatic squamous forms that are not resectable first-line treatment of NSCLC and in combination with bevacizumab for the first-line treatment of hepatocellular carcinoma. Tyvyt is indicated in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

IBI-308 is under development for the treatment of recurrent or metastatic angiosarcoma, metastatic undifferentiated pleomorphic sarcoma, mucoepidermoid carcinoma, acinic cell carcinoma, oral cavity squamous cell carcinoma and oropharyngeal squamous cell carcinoma, squamous non-small cell lung cancer, salivary gland cancer, adenoid cystic carcinoma, hepatocellular carcinoma, angioimmunoblastic T-cell lymphoma, rectal cancer, advanced metastatic urothelial carcinoma, triple negative breast cancer, recurrent and or metastatic head and neck squamous cell carcinoma, higher-risk myelodysplastic syndrome, endometrial cancer, hepatocellular carcinoma (HCC), EBV-associated lymphoproliferative disease including relapse/refractory EBV-related hemophagocytic syndrome, non-metastatic rectal cancer, muscle invasive bladder cancer (MIBC), acral melanoma, advanced pancreatic cancer, brain tumor, melanoma, melanoma (adjuvan) therapy, primary mediastinal B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphomas, intrahepatic cholangiocarcinoma, metastatic renal cell carcinoma, classic Hodgkin's lymphoma, various tumor types including dedifferentiated liposarcoma, nasopharyngeal cancer, neuroendocrine tumors gastric cancer, melanoma, metastatic esophageal squamous cell carcinoma, bladder cancer, small-cell lung cancer, metastatic colorectal cancer, endometrial cancer, adenocarcinoma of the gastroesophageal junction, hepatocellular carcinoma, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, cervical cancer, thoracic malignancies, recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal adenocarcinoma and dMMR/MSI-H Stage III colorectal cancer, metastatic cutaneous melanoma and metastatic pancreatic cancer. It is administered intravenously. The drug candidate is a monoclonal antibody and targets immune checkpoint, programmed cell death protein 1 (PD1). It was also under development for Non-Hodgkin lymphoma, kidney cancer and  metastatic prostate cancer.

Eli Lilly and Co overview

Eli Lilly and Co (Lilly) is a healthcare company that is engaged in the discovery, development, and marketing of human healthcare products. The company offers medicines for cardiovascular conditions, diabetes, endocrinology, cancer, neurological problems, immune disorders, men’s health and musculoskeletal problems. The company distributes its pharmaceutical health products through independent wholesale distributors. Lilly conducts research and development activities to discover and deliver innovative medicines. It also promotes products through sales representatives and marketing agreements with other pharmaceutical companies. The company also offers its products in North America, South America, Europe, South Asia, the Middle East, Africa and North Asia-Pacific. Lilly is headquartered in Indianapolis, Indiana, the US.

For a complete picture of Sintilimab’s drug-specific PTSR and LoA scores, buy the report here.


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.