Tremelimumab by AstraZeneca for Renal Cell Carcinoma: Likelihood of Approval

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.

Tremelimumab overview

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 pancreas and 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.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly- owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

For a complete picture of Tremelimumab’s drug-specific PTSR and LoA scores, buy the report here.

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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.