Sacituzumab govitecan is under clinical development by Gilead Sciences and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sacituzumab govitecan’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Sacituzumab Govitecan in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer)

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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.

Sacituzumab govitecan overview

Sacituzumab govitecan (Trodelvy) is a conjugated humanized monoclonal antibody with potential antineoplastic activity. It is formulated as lyophilized powder for solution for intravenous route of administration. Trodelvy is indicated for the treatment of adult patients with unresectable or locally advanced metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Sacituzumab govitecan (IMMU-132) is under development for the treatment of advanced or metastatic urothelial carcinoma, Leptomeningeal disease papillary thyroid cancer,  differentiated thyroid carcinoma (thyroid cancer), anaplastic thyroid carcinoma (ATC), hepatocellular carcinoma, refractory or relapsed advanced including epithelial ovarian cancer, colorectal, gastric, hepatocellular, bladder cancer, head and neck squamous cell carcinoma, diffuse pleural mesothelioma, metastatic hormone-refractory prostate, small-cell and metastatic non-small-cell lung cancer,squamous non-small cell lung cancer, pancreatic ductal adenocarcinoma, HER2 negative breast cancer, esophageal, renal cell cancer, metastatic transitional (Urothelial) tract cancer, endometrial cancer, cervical cancer, esophageal squamous cell carcinoma (escc), adenocarcinoma of the gastroesophageal junction, biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, lung adenocarcinoma, glioblastoma multiforme malignant glioma, muscle invasive bladder cancer, salivary gland cancer, adenoid cystic carcinoma, fallopian tube cancer, peritoneal cancer, metastatic cholangiocarcinoma, thymic carcinoma and metastatic breast cancer with brain metastasis. It is administered as an intravenous route. IMMU-132 is a camptothecin-based ADC where the antibody, RS7 is attached to SN38. IMMU-132 targets cells expressing TROP-2. It was also under development for follicular thyroid cancer,  metastatic triple-negative breast cancer and adenocarcinoma.

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It carries out the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases such as hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, cancer, and human immunodeficiency virus (HIV) infection. It markets its products through commercial teams, third-party distributors and corporate partners. Gilead’s commercial teams promote its products through direct field contact with physicians, hospitals, clinics and other healthcare providers. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East, and Africa. Gilead is headquartered in Foster City, California, the US.

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

This content was updated on 16 July 2024

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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.