Onvansertib fumarate is under clinical development by Cardiff Oncology and currently in Phase II for Metastatic Colorectal Cancer. According to GlobalData, Phase II drugs for Metastatic Colorectal Cancer have a 34% 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.
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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.
Onvansertib fumarate overview
Onvansertib fumarate (PCM-075) is under development for the treatment of pancreatic ductal adenocarcinoma, chronic myelomonocytic leukemia and advanced or metastatic solid tumors including triple negative breast cancer, small-cell lung cancer, ampullary 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.
It was also under development for the treatment of Chronic Myelomonocytic Leukemia (CMML), ovarian cancer, lung cancer, prostate cancer, colorectal cancer, Head And Neck Cancer, Pancreatic Cancer, hepatocellular cancer, sarcomas relapsed or refractory acute myeloid leukemia and medulloblastoma.
Cardiff Oncology overview
Cardiff Oncology (Cardiff) is a clinical-stage biotechnology company. It is dedicated to developing novel therapies by inhibiting Polo-like kinase 1 (PLK1), targeting significant unmet medical needs in cancer. The company’s lead product candidate, onvansertib, specifically targets PLK1, a well-established target in cancer therapy. Cardiff is advancing various clinical trials, including the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC) and the TROV-054 trial for second-line KRAS-mutated mCRC. It is also investigating onvansertib for metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer, exploring various combination therapies. Cardiff 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.
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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.
