Fast Track Designation Granted to Drug for KRAS-Mutated Metastatic Colorectal Cancer

FDA has granted Fast Track designation to Cardiff Oncology’s onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

Officials with the FDA have granted Fast Track designation to Cardiff Oncology’s onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).

Fast Track designation is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug to address this medical need.

According to Cardiff Oncology, a clinical-stage oncology therapeutics company, onvansertib is a first-in-class, third-generation, and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme that is over-expressed in multiple cancers including leukemias, lymphomas, and solid tumors. The drug targets the PLK1 isoform only, is orally administered, and has a 24-hour half-life with only mild-to-moderate adverse effects reported.

In the open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and bevacizumab (Avastin) is being evaluated for safety and efficacy for second-line treatment of patients with KRAS-mutated mCRC. The trial will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. Patients participating in the trial must have failed treatment or be intolerant of FOLFOX (fluoropyrimidine and oxaliplatin) with or without bevacizumab.

The trial is being conducted at 2 cancer centers: USC Norris Comprehensive Cancer Center in California and The Mayo Clinic in Arizona.

REFERENCE

Cardiff Oncology Announces Fast Track Designation Granted by FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer [news release]. San Diego, CA; May 28, 2020: Cardiff Oncology website. https://cardiffoncology.investorroom.com/2020-05-28-Cardiff-Oncology-Announces-Fast-Track-Designation-Granted-by-the-FDA-to-Onvansertib-for-Second-Line-Treatment-of-KRAS-Mutated-Colorectal-Cancer. Accessed May 28, 2020.