Sapanisertib is under clinical development by Calithera Biosciences and currently in Phase II for Metastatic Transitional (Urothelial) Tract Cancer. According to GlobalData, Phase II drugs for Metastatic Transitional (Urothelial) Tract Cancer have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sapanisertib’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.

Sapanisertib overview

Sapanisertib (MLN-0128, INK-128) is under development for the treatment of metastatic estrogen receptor (ER) positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer, metastatic urothelial cancer, metastatic anaplastic thyroid cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, pancreatic neuroendocrine tumor, squamous non-small cell lung cancer, metastatic hepatocellular carcinoma, recurrent glioblastoma multiforme, gliosarcoma and pleomorphic sarcoma including malignant fibrous histiocytoma, leiomyosarcoma, malignant peripheral nerve sheath tumor, synovial sarcoma and pediatric low-grade gliomas. The drug candidate is a small molecule and administered through the oral route. It acts by targeting both TORC1 and TORC2 complexes of mTOR (mammalian target of rapamycin) kinase. It was also under development for the treatment of Hodgkin lymphoma, metastatic castration-resistant prostate cancer, Merkel cell carcinoma, advanced nonhematological malignancies including metastatic brain tumor, idiopathic pulmonary fibrosis, endometrial cancer, relapsed or refractory multiple myeloma, acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma, marginal zone B-cell lymphoma, mantle cell lymphoma, follicular lymphomarenal cell carcinoma, medulloblastoma and Waldenstrom macroglobulinemia.

It was also under development for the treatment recurrent head and neck cancer squamous cell carcinoma, esophageal squamous cell carcinoma

Calithera Biosciences overview

Calithera Biosciences (Calithera) is a clinical-stage bio-pharmaceutical company that discovers and develops novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. The company’s product pipeline includes CB-839, a glutaminase inhibitor in tumor metabolism to treat solid tumors, NCB001158, a small molecule arginase inhibitor based on tumor immunology technology that activates the body’s own immune system to attack and kill cancer cells for the treatment of hematology and oncology diseases, CB-280, a arginase inhibitor used for treating Cystic Fibrosis, CB-708, a CD73 inhibitor against immuno-oncology conditions and IL4I1 Inhibitor CB-668 against immuno-oncology conditions. The company works in collaboration with bio-pharmaceutical companies such as Incyte Corp, Bristol-Myers Squibb (BMS), and Mars Symbiosciences Inc. Calithera is headquartered in South San Francisco, California, the US.

For a complete picture of Sapanisertib’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.