On Tuesday, Cardiff Oncology, Inc. ( CRDF ) revealed initial data from the CRDF-004 Phase 2 trial, which evaluates onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

The CRDF-004 phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation.

Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are being randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.

Efficacy and safety data are for all evaluable patients as of November 26.

An objective response rate of 57% was observed in all onvansertib patients, with 50% in the 20mg dose of onvansertib + SoC arm and 64% in the 30mg dose of onvansertib + SoC arm, compared to 33% in the SoC alone arm.

Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib combined with the SoC compared to the control arms and 20mg dose of onvansertib arms.

Onvansertib, in combination with chemo/bevacizumab, was well-tolerated, and no major or unexpected toxicities were observed.

Additional clinical data from the CRDF-004 trial is expected in 1H 2025.

"We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology ( CRDF ).

"Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses."

Price Action: CRDF stock was trading 52% higher to $3.71 at the last check on Tuesday.

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