Likelihood of Approval and Phase Transition Success Rate Model – Tislelizumab in Gastroesophageal (GE) Junction Carcinomas
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How likely is it that a drug will get approved? Will the drug transition to the next phase of its clinical pathway? This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.
Tislelizumab in Gastroesophageal (GE) Junction Carcinomas Drug Details:
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 also 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, recurrent head and neck cancer squamous cell carcinoma, 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, cholangiocarcinoma, 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, adrenocortical carcinoma, metastatic esophageal squamous cell carcinoma, urothelial 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, muscle invasive bladder cancer (MIBC), metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, T-cell lymphomas such as anaplastic T-cell lymphoma, Extranodal NK/T-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), relapsed or refractory classical Hodgkin lymphoma (cHL), gastrointestinal stromal tumor (GIST), mantle cell lymphoma, marginal zone B cell lymphoma, adenoid cystic carcinoma, nasopharyngeal cancer, renal pelvis cancer, ureter cancer, bladder cancer, nasopharyngeal cancer, oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal 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, ESCC, NSCLC, adenocarcinoma of the gastroesophageal junction, RHNSCC, esophageal cancer ,TNBC, sezary syndrome, mycosis fungoides, GIST, HCC, angioimmunoblastic T-cell lymphoma (AITL)/immunoblastic lymphadenopathy, peripheral T-cell lymphomas (PTCL), natural killer cell lymphomas, anaplastic large cell lymphoma (ALCL), endometrial cancer, fallopian tube cancer, head and neck cancer squamous cell carcinoma, merkel cell carcinoma, metastatic adenocarcinoma of the pancreas, brain metastasis, metastatic castration-resistant prostate cancer (mCRPC), muscle invasive bladder cancer (MIBC), ovarian cancer, pancreatic cancer, peritoneal cancer, renal cell carcinoma, sarcomas, small-cell lung cancer, squamous cell carcinoma, thyroid cancer.
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
|Quick View – Tislelizumab LOA Data|
|Drug Development Status||
Reasons to Buy
- Predict the specific likelihood of approval and phase transition success rates of a drug using a combination of machine learning and proprietary models
- Get information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies
- Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR
- Use PTSR and LOA information and event-driven changes for your investment decisions.
Frequently asked questions
- Drugs which have been approved in the past 10 years
- Drugs which have failed during clinical development in the past 18 years
- Drugs which are currently in development
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- Drugs must meet one of the following criteria to be included in the model:
- The developer has specified the US as an intended market for approval.
- The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”
- Innovator drugs and biosimilars
- Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
- Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
- Generic drugs
- Innovative drugs in Preclinical or Discovery Stage.
- Pipeline drugs sponsored by a Government or Institution.
- Drugs with a specific Drug Geography not the United States.
The probability of a drug ultimately receiving market authorization
The probability of a drug’s advancement to the next stage of clinical development
GlobalData’s Drug-Specific Likelihood of Approval (LoA) calculates the Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases.
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
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