Tislelizumab is under clinical development by Novartis and currently in Phase III for Non-Small Cell Lung Cancer. According to GlobalData, Phase III drugs for Non-Small Cell Lung Cancer have a 48% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tislelizumab’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.
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.
Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.
For a complete picture of Tislelizumab’s drug-specific PTSR and LoA scores, buy the report here.