CRDF Stock Soars on Robust Efficacy Data From Colorectal Cancer Study
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Cardiff Oncology CRDF announced robust efficacy data from an ongoing mid-stage study evaluating two doses of its lead investigational candidate, onvansertib (20 mg and 30 mg), in combination with standard-of-care (SOC) chemotherapy to treat first-line RAS-mutated metastatic colorectal cancer (mCRC) patients. The stock rallied 54.9% on Tuesday following the encouraging news. The primary endpoint of the study was objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), duration of response and safety.
Per the data from the phase II CRDF-004 study, treatment with the 30 mg dose of onvansertib, a PLK1 inhibitor, demonstrated an ORR of 64%, almost double the 33% ORR observed in the control arm (SOC alone). The 30 mg dose arm also demonstrated a higher ORR compared with the 50% ORR observed in the 20 mg dose arm. Overall, patients treated with onvansertib demonstrated an ORR of 57%.
The company also shared spider plots in the press release which show that patients receiving the 30mg dose of onvansertib with SOC experienced greater tumor size reduction over time compared to those in the control and 20mg dose arms with similar safety profiles for both doses. The combo therapy was also well tolerated in the CRDF-004 study with no major or unexpected toxicities observed.
Based on the encouraging data readout, management believes that onvansertib has the potential to revolutionize the treatment paradigm for the first-line RAS-mutated mCRC patient population. Approximately 50,000 new patients with this mCRC indication are diagnosed in the United States, annually.
In the past three months, shares of Cardiff Oncology have rallied 47.7% against the industry’s 6.2% decline.
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CRDF’s Next Steps in Onvansertib Development for mCRC
Cardiff Oncology expects to share additional clinical updates from the mid-stage study in the first half of 2025. Subject to positive results from the phase II CRDF-004 study, Cardiff plans to initiate a phase III CRDF-005 registrational study for the onvansertib/SOC combo to treat patients with first-line RAS-mutated mCRC.
Furthermore, the FDA has also agreed with the company that an interim analysis of ORR in the planned registrational study can provide the basis for an application seeking approval for the onvansertib/SOC combo under an accelerated pathway. Under such circumstances, PFS and overall survival data will be designated as endpoints for full approval.
We note that last year, Cardiff discontinued its phase II ONSEMBLE study evaluating onvansertib in combination with SOC therapy to treat patients with second-line RAS-mutated mCRC. The strategic decision was taken to focus the company's resources on its phase II CRDF-004 study in the first-line setting, where there is a higher unmet need.