Tislelizumab is under clinical development by BeiGene and currently in the Phase I, Phase II, Phase III and Pre-Registration 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 Tislelizumab’s likelihood of approval (LoA) and phase transition for Metastatic Adenocarcinoma of The Pancreas took place on 08 Nov 2022, which increased 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 Tislelizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tislelizumab overview

Tislelizumab (Baizean) is a humanized monoclonal antibody that belongs to a class of immuno-oncology agents. It is formulated as powder for solution for intravenous route of administration. Baizean is used for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies and treatment for patients with locally advanced or metastatic urothelial carcinoma (UC). It is also indicated as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Baizean is indicated for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan and other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options. Baizean is indicated as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. Tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). It is aslo indicated to treat cancers associated with homologous-recombination deficient (HRD).

Tislelizumab is under development for the treatment of locally advanced rectal cancer, hepatocellular carcinoma (HCC), acute myelocytic leukemia, relapsed and refractory acute myeloid leukemia, high-risk myelodysplastic syndromes, primary mediastinal large B-cell lymphoma, triple negative breast cancer (TNBC), gallbladder cancer, pancreatic ductal adenocarcinoma, locally advanced or metastatic urothelial carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, metastatic esophageal, HER2 positive breast cancer, gastric, or gastroesophageal junction carcinoma (as a first line therapy), squamous non-small cell lung cancer, advanced solid tumors such as triple negative breast cancer, ovarian cancer, colorectal cancer, cervical cancer, pancreatic cancer, gastric cancer, hepatocellular carcinoma, non-squamous non-small cell lung cancer, sarcomas, endometrial cancer, cholangiocarcinoma, brain metastasis, chronic lymphocytic leukemia (CLL), follicular lymphoma, aggressive lymphoma, including diffuse large B-cell lymphoma (DLBCL), renal cell carcinoma, squamous cell carcinoma, cutaneous squamous cell carcinoma, adrenocorticoid carcinoma, thyroid cancer, metastatic esophageal squamous cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, mesothelioma, adenocarcinoma of mandible, undifferentiated adenocarcinoma from teratoma, blood borne cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, small-cell lung cancer, peritoneal cancer, fallopian tube cancer, muscle invasive bladder cancer (MIBC), metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, T-cell lymphomas such as angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma-NOS, anaplastic T-cell lymphoma, Extranodal NK/T-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), relapsed or refractory classical Hodgkin lymphoma (cHL), mycosis fungoides, gastrointestinal stromal tumor (GIST), mantle cell lymphoma, marginal zone B cell lymphoma, adenoid cystic carcinoma, nasopharyngeal cancer, sezary syndrome, renal pelvis cancer, ureter cancer, bladder cancer, nasopharyngeal cancer, oral cavity cancer or urethral cancer. It is administered by intravenous drip route. The drug candidate is a highly selective and potent, humanized anti-PD-1 monoclonal antibody. It was also under treatment for the treatment of duodenal cancer, anal squamous cell cancer, glioblastoma multiforme, Waldenstrom macroglobulinemia.

BeiGene overview

BeiGene is a biotechnology company. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers BRUKINSA, a BTK (Bruton’s tyrosine kinase) inhibitor against mantle cell lymphoma (MCL). BeiGene is investigating Zanubrutinib (BGB-3111), a small molecule inhibitor of BTK to treat B cell malignancies; Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. It seeks to work in partnership with academia, biotechnology and pharmaceutical companies to develop treatments for cancer patients. The company has operations in the US, Australia, Germany, Spain Switzerland, and Italy. BeiGene is headquartered in Beijing, China.

Quick View Tislelizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tislelizumab
Administration Pathway
  • Intravenous
  • Intravenous Drip
Therapeutic Areas
  • Oncology
Key Developers
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.