Alisertib is under clinical development by Puma Biotechnology and currently in Phase II for Small-Cell Lung Cancer. According to GlobalData, Phase II drugs for Small-Cell Lung Cancer have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Alisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
Alisertib overview
Alisertib (MLN-8237) is under development for the treatment of solid tumors including stage IV EGFR-mutated non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), HER2 negative breast cancer, recurrent and refractory central nervous system atypical teratoid rhabdoid tumors (ATRT), triple negative breast cancer. It is a second-generation, orally bio-available, highly selective small molecule inhibitor of the serine/threonine protein kinase Aurora A kinase with potential anti-neoplastic activity. The drug candidate was under development for the treatment of Waldenstrom macroglobulinemia, malignant pleural mesothelioma, high-grade glioma, Hodgkin's lymphoma, non-Hodgkin lymphoma including diffuse large B-cell lymphoma, B-cell lymphomas, relapsed or refractory transitional-cell carcinoma of the bladder and urothelial tract, relapsed or refractory peripheral T-cell lymphoma, precursor cell lymphoblastic leukemia-lymphoma, myelodysplastic syndrome, non-small cell lung cancer, gastroesophageal (GE) junction carcinomas, anaplastic astrocytoma, small-cell lung cancer, refractory or relapsed multiple myeloma, relapsed or refractory CD30-positive lymphomas such as Hodgkin's and anaplastic large cell lymphoma, squamous cell cancer of the head and neck, epithelial ovarian cancer, fallopian tube cancer, and relapsed and refractory B-cell chronic lymphocytic leukemia, relapsed/refractory neuroblastoma, neuroendocrine prostate cancer (NEPC) and hormone refractory (castration-resistant, androgen-independent) prostate cancer, peritoneal cancer, CD30-positive cancers such as testicular embryonal carcinoma, cutaneous angiosarcoma, nasopharyngeal non-keratinizing carcinoma and metastatic HPV associated cancers including cervical, vaginal, vulvar, penile, anal or oropharyngeal carcinoma and acute myelogenous leukemia.
Puma Biotechnology overview
Puma Biotechnology (Puma) is a biopharmaceutical company. It focuses on developing and commercializing novel therapeutics for the treatment of cancer. The company’s product portfolio consists of Nerlynx (neratinib) tablets, a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and cancer that has spread to other parts of the body (metastatic). Its product pipeline also consists of Alisertib, a selective, small-molecule inhibitor of aurora kinase A that is used in the treatment of non small cell lung cancer and breast cancer. The company manufactures, supplies, stores and distributes its products through third-party contractors. Puma is headquartered in Los Angeles, California, the US.
For a complete picture of Alisertib’s drug-specific PTSR and LoA scores, buy the report here.
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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.
