Clinical trial to evaluate onvansertib as first-line mCRC treatment

People with RAS-mutated metastatic colorectal cancer (mCRC) have seen little progress in first-line treatment options over the past two decades, but that could soon change for thousands of new patients, according to a press release from Cardiff Oncology.

Cardiff has announced plans to conduct a phase-two trial to evaluate its drug onvansertib as a first-line therapy. The trial will be supported by Pfizer Ignite, a new end-to-end service for biotech companies. If the trial has promising results, a phase-three trial will launch, with Cardiff focused on accelerated approval of the therapy from the Food and Drug Administration.

"We believe onvansertib, by inhibiting PLK1, has the potential to play a meaningful role in the treatment of several types of cancer,” including RAS-mutated mCRC, said Dr. Schayowitz, a vice president at Pfizer. "We believe that by combining Pfizer's clinical development capabilities and expertise, with onvansertib's promising novel clinical findings, we have an opportunity to accelerate the advancement of this program for the benefit of the many patients in the RAS-mutated mCRC setting."

The plans for a phase-two trial follow “stand-out results” from an earlier study, in which onvansertib performed well as a second-line treatment in a subset of mCRC patients, particularly those who had not previously been previously treated with bevacizumab, according to Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. Among patients in the study, 73% had their tumors shrink, and the median length of progression-free survival (mPFS) was 15 months. 

"Our advance to the first-line setting is the result of a comprehensive data-driven review coupled with the agreement and support of the FDA," said Mark Erlander, CEO of Cardiff.

The availability of this as a first-line trial for metastatic colorectal cancer underscores the importance of patients speaking with their oncologists about the applicability of clinical trials for them early in their cancer journey. 

Read the full press release from Cardiff Oncology.