Onvansertib fumarate is under clinical development by Cardiff Oncology and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Onvansertib fumarate’s likelihood of approval (LoA) and phase transition for Colorectal Cancer took place on 20 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Onvansertib fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Onvansertib fumarate LOA Data

Report Segments
  • Innovator
Drug Name
  • Onvansertib fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.