Likelihood of Approval and Phase Transition Success Rate Model – Tremelimumab in Gastroesophageal (GE) Junction Carcinomas

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Tremelimumab in Gastroesophageal (GE) Junction Carcinomas

Published: November 03, 2023 Report Code: GDHCDR8880LOA-MP-L5

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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.


Tremelimumab in Gastroesophageal (GE) Junction Carcinomas Drug Details:

Tremelimumab (Imjudo) human monoclonal monospecific antibody against CTLA-4. It is formulated as a solution and concentrated solution for intravenous and subcutaneous route of administration. Imjudo is indicated in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma and in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor. Tremelimumab (CP-675206) is under development for the treatment of squamous and KRAS and STK11 mutated metastatic non-squamous non-small cell lung cancer, cutaneous melanoma, urothelial bladder cancer, poorly differentiated thyroid carcinoma, anaplastic thyroid cancer, follicular thyroid cancer, medullary thyroid cancer and papillary thyroid cancer, renal cell carcinoma, metastatic breast cancer, gastric cancer, hepatocellular carcinoma, breast cancer, oral cancer, oropharyngeal cancer, laryngeal cancer, metastatic adenocarcinoma of the pancreasand castrate resistant prostate cancer. The drug candidate is administered intravenously. It is fully human monoclonal antibody targeting human cytotoxic T lymphocyte–associated antigen 4 (CTLA-4, CD152). It was also under development for the treatment of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, HIV / AIDS, bladder cancer, colorectal cancer, prostate cancer, gastrointestinal tract cancer, metastatic melanoma, unresectable advanced solid tumors and pleural malignant mesothelioma, pancreatic ductal adenocarcinoma, HPV negative head and neck squamous cell carcinoma and adenocarcinoma of the gastroesophageal junction.

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.

Quick View – Tremelimumab LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Tremelimumab
Administration Pathway
· Intravenous| Subcutaneous
Therapeutic Areas
· Infectious Disease| Oncology
Key Manufacturers
· AstraZeneca Plc
Drug Development Status
· Marketed

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

    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:

    • 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

    Drug Phase Scope:

    • Phase I, Phase II, Phase III, and Pre-Registration development stage

    Drug Geography Scope:

    • 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”

    Drug Type Scope:

    • Innovator drugs and biosimilars

    Entity Type Scope:

    Only drugs in development by companies are included in the model.

    Exclusion

    • 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.

     

lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Tremelimumab in Gastroesophageal (GE) Junction Carcinomas
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