Cardiff Oncology's Promising Trial Results in RAS-Mutated Cancer
San Diego, Tuesday, 10 December 2024.
Cardiff Oncology reports a 64% response rate in its Phase 2 trial for RAS-mutated colorectal cancer, marking a potential breakthrough in treatment efficacy and safety.
Trial Details and Initial Results
Cardiff Oncology (NASDAQ: CRDF) has released groundbreaking data from its CRDF-004 Phase 2 clinical trial on December 10, 2024 [1][4]. The trial evaluates onvansertib, the company’s lead PLK1 inhibitor, in combination with standard-of-care (SoC) treatments for patients with first-line RAS-mutated metastatic colorectal cancer (mCRC) [2]. The data, based on a November 26, 2024 cutoff date, shows remarkable efficacy with a 57% objective response rate (ORR) across all onvansertib treatment groups [4].
Dosage Effectiveness and Control Comparison
The trial demonstrates particularly promising results at higher dosage levels. Patients receiving the 30mg dose of onvansertib combined with standard-of-care achieved a 64% objective response rate, significantly outperforming both the 20mg dosage group (50% ORR) and the control group receiving standard-of-care alone (33% ORR) [4]. The study utilizes a 1:1:1 randomization ratio, comparing two different onvansertib dosages (20mg and 30mg) plus SoC against SoC alone [4].
Safety Profile and Future Outlook
According to Chief Medical Officer Fairooz Kabbinavar, the treatment demonstrates a favorable safety profile, with no major or unexpected toxicities observed when combining onvansertib with chemotherapy and bevacizumab [4]. The company’s development strategy specifically targets tumor vulnerabilities to overcome treatment resistance [2]. Investors and healthcare professionals can anticipate additional clinical data from the CRDF-004 trial in the first half of 2025 [4].
Market Impact and Company Position
As a clinical-stage biotechnology company, Cardiff Oncology’s positive trial results represent a significant milestone in their mission to develop new oncology therapeutic options [2]. The market has responded positively to these developments, with the company’s stock showing a 52% increase to $3.71 following the announcement [4]. The company’s broader development strategy includes additional clinical programs targeting various cancer indications where new treatment options are critically needed [2].