Cardiff Oncology Reports Encouraging Results in mCRC Trial

Cardiff Oncology Reveals Promising Clinical Trial Results

Cardiff Oncology, Inc. (Nasdaq: CRDF), a pioneering clinical-stage biotechnology company, has recently announced encouraging results from its ongoing CRDF-004 clinical trial. This randomized Phase 2 trial is investigating the effects of onvansertib in patients suffering from first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial showcases a significant increase in confirmed overall response rates (ORR) among patients receiving the 30mg dose of onvansertib compared to the control group.

Key Findings from the Trial

The results indicate a 49% confirmed ORR for patients receiving the 30mg dose of onvansertib, contrasting with a 30% ORR in the control group. Moreover, the data indicates a trend towards prolonged progression-free survival (PFS) favoring the group administered the 30mg dose, suggesting that onvansertib might enhance outcomes in patients with mCRC linked to RAS mutations.

Significance of Early Findings

Roger Sidhu, MD, Chief Medical Officer of Cardiff Oncology, expressed optimism regarding these early findings. He highlighted a 19% improvement in confirmed ORR, emphasized the shorter response time, and observed deeper tumor regression in patients receiving the combination treatment when compared to standard-of-care (SoC) alone. These results strengthen previous findings and highlight onvansertib’s potential as a transformative treatment option.

Trial Design Insights

The CRDF-004 trial included a total of 110 patients with documented KRAS or NRAS mutations. These patients were assigned to various treatment arms; some received onvansertib combined with standard treatments such as FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab, while others were treated only with SoC. The primary measure of efficacy is the overall response rate (ORR), with secondary endpoints encompassing progression-free survival and safety metrics.

Evaluating Efficacy Data

As of the latest data review, the confirmed ORR data was as follows: the control arm (30%), the 20mg dose of onvansertib (42%), and the 30mg dose (49%). These statistics exemplify the increasing efficacy associated with higher doses of onvansertib, demonstrating its potential as an impactful alternative in mCRC treatments.

Safety and Tolerability of Onvansertib

In terms of safety, the analysis focused on 104 patients, revealing that onvansertib in conjunction with chemotherapy and bevacizumab was well tolerated. Notably, there were no significant toxicities related to the treatment, though neutropenia was observed as a common adverse effect. These findings signal that patients may endure this regimen with manageable side effects.

Looking Ahead: Future Milestones

Mark Erlander, CEO of Cardiff Oncology, shared his enthusiasm for the trial's outcomes, citing confidence as the company prepares for discussions with the FDA regarding future registration trials. The upcoming CRDF-005 trial is anticipated to further explore the role of onvansertib in cancer treatment. Patients and stakeholders can expect a detailed update on the first-line mCRC program within the next year, providing insights into the path for onvansertib's regulatory approval process.

Frequently Asked Questions

What is Cardiff Oncology's leading product?

Cardiff Oncology's leading product is onvansertib, a PLK1 inhibitor aimed at treating various cancers, especially mCRC.

What are the main findings from the clinical trial?

The trial found a 49% confirmed overall response rate for the 30mg dose of onvansertib, significantly higher than the control arm's 30%.

What was the study's trial design?

The CRDF-004 trial enrolled patients with confirmed KRAS or NRAS mutations, assigning them to either a control group or one of the treatment arms with varying doses of onvansertib.

How well was onvansertib tolerated by patients?

Onvansertib was well-tolerated with no major unexpected toxicities, although some patients experienced neutropenia.

When can we expect updates on the trial's progress?

Cardiff Oncology plans to provide an update on the first-line mCRC program by Q1 2026.

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