Alisertib is under clinical development by Puma Biotechnology and currently in Phase II for Recurrent Head And Neck Cancer Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Recurrent Head And Neck Cancer Squamous Cell Carcinoma have a 37% 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.

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), recurrent and refractory central nervous system atypical teratoid rhabdoid tumors (ATRT), malignant pleural mesothelioma, 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, 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 that develops novel therapeutics for the treatment of cancer. The company develops and commercializes drug candidates, namely, PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Its pipeline portfolio also encompasses investigational candidates for various indications such as adjuvant breast cancer, gastric cancer, metastatic breast cancer and HER2-positive breast cancer and other cancers. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. Puma manufacture and distribute its products through the 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.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.