Likelihood of Approval and Phase Transition Success Rate Model – Toripalimab in Ewing Sarcoma
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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.
Toripalimab in Ewing Sarcoma Drug Details:
Toripalimab (Tuoyi) is a monoclonal antibody, acts as an anti-neoplastic agent. It is formulated as injectable solution for intravenous route of administration. Tuoyi is used to treat local progression or metastatic melanoma after failure of previous standard treatment. Tuoyi is indicated for treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Toripalimab is indicated for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Tuoyi in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”). Tuoyi in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer. JS-001 is under development for the treatment of advanced resectable oral squamous cell carcinoma (OSCC), locally advanced anal canal squamous carcinoma, intrahepatic cholangiocarcinoma, salivary gland cancers including mucoepidermoid carcinoma, adenoid cystic carcinoma (ACC), acinic cell carcinoma, advanced thymic carcinoma, recurrent, or metastatic cervical cancer, hypopharyngeal carcinoma, soft tissue sarcoma including synovial sarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undiffertiated sarcoma, bone sarcoma, chondrosarcoma, ewing’s sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, myofibroblastic sarcoma, malignant solitary fibroma, postradiation sarcoma, local advanced laryngeal, hypopharyngeal carcinoma, advanced esophageal squamous cell carcinoma, metastatic renal cell carcinoma (RCC), newly diagnosed early-stage extranodal natural killer/T cell lymphoma, advanced solid tumors including gastric cancer, metastatic colorectal cancer, ampullary carcinoma (a type of gallbladder cancer), mixed carcinoma, gallbladder cancer, such as adenocarcinoma of the gastroesophageal junction (gastric cancer), endometrial cancer, metastatic melanoma (first-line therapy), cholangiocarcinoma, metastatic breast cancer, colon cancer, small-cell lung cancer, esophageal squamous cell carcinoma, pancreatic ductal cell carcinoma, hepatocellular carcinoma, kidney cancer, urological cancers, triple-negative breast cancer, colorectal cancer, bladder urothelial carcinoma, chondrosarcoma, head and neck squamous cell carcinoma, throat cancer, neuroendocrine carcinoma, squamous non-small cell lung Cancer non-small cell lung cancer, Hodgkin lymphoma, B-cell non Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Muscle-invasive Urothelial Bladder Cancer, advanced differentiated thyroid cancer, papillary thyroid cancer, rectal cancer and follicular thyroid cancer. It is under development for the prevention of adenomatous polyps and second primary tumors in lynch syndrome (colorectal cancer), metastatic urothelial carcinoma.It was also under development for the treatment of epithelial ovarian cancer, metastatic castration-resistant prostate cancer, muscular-invasive bladder cancer, ureteral cancer, urethral or pelvic cancer), and advanced or metastatic pancreatic adenocarcinoma.
Report Coverage
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.
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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.
Inclusion
Data Scope:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
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