Onvansertib fumarate is under clinical development by Cardiff Oncology and currently in Phase II for Small-Cell Lung Cancer. According to GlobalData, Phase II drugs for Small-Cell Lung Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Onvansertib fumarate’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.

Onvansertib fumarate overview

Onvansertib fumarate (PCM-075) is under development for the treatment of relapsed or refractory acute myeloid leukemia, pancreatic ductal adenocarcinoma, chronic myelomonocytic leukemia and advanced or metastatic solid tumors including triple negative breast cancer, medulloblastoma, small-cell lung cancer, colorectal cancer, sarcomas, hepatocellular cancer, ampullary cancer, prostate cancer, ovarian cancer, skin cancer and hormone refractory (castration-resistant, androgen-independent) prostate cancer. The drug candidate is administered through the oral route. The drug candidate is a 4,5-dihydro-1H-pyrazolo[4,3- h]quinazoline derivative. The drug candidate is a first in class third generation drug acts by targeting Polo-like-kinase 1 (PLK1). It was also under development for adrenocortical carcinoma (adrenal cortex cancer),non-Hodgkin lymphoma and myelodysplastic syndrome.

Cardiff Oncology overview

Cardiff Oncology, formerly Trovagene Inc is a clinical-stage biotechnology company that focuses on developing drugs which target cell division (mitosis) using precision cancer medicine (PCM) approach for the treatment of hematologic and solid tumor cancers. The company lead product candidate is Onvansertib (previously known as PCM-075), an oral and adenosine triphosphate (ATP) competitive inhibitor of polo-like kinase 1 (PLK1) enzyme. It is being developed in combination with chemotherapies and targeted therapeutics for treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), metastatic Castration-Resistant Prostate Cancer (mCRPC) and second-line KRAS mutation-metastatic Colorectal Cancer (mCRC). Onvansertib is being evaluated in three clinical trials, namely, TROV-052, TROV-053, and TROV-054. Cardiff Oncology is headquartered in San Diego, California, the US.

For a complete picture of Onvansertib fumarate’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.