On Tuesday, Cardiff Oncology, Inc. CRDF revealed preliminary information from the CRDF-004 Section 2 trial, which evaluates onvansertib together with standard-of-care (SoC) in sufferers with first-line RAS-mutated metastatic colorectal most cancers (mCRC).
The CRDF-004 part 2 trial is at present enrolling sufferers with mCRC who’ve a documented KRAS or NRAS mutation.
Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Sufferers are being randomized in a 1:1:1 ratio to both 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
Efficacy and security information are for all evaluable sufferers as of November 26.
An goal response charge of 57% was noticed in all onvansertib sufferers, with 50% within the 20mg dose of onvansertib + SoC arm and 64% within the 30mg dose of onvansertib + SoC arm, in comparison with 33% within the SoC alone arm.
Spider Plots, displaying the change in tumor measurement from baseline for every affected person over time, exhibit deeper responses noticed in sufferers receiving the 30mg dose of onvansertib mixed with the SoC in comparison with the management arms and 20mg dose of onvansertib arms.
Onvansertib, together with chemo/bevacizumab, was well-tolerated, and no main or surprising toxicities have been noticed.
Extra medical information from the CRDF-004 trial is anticipated in 1H 2025.
“We’re extremely inspired by the strong efficacy sign and favorable security profile noticed with onvansertib plus standard-of-care from the primary 30 evaluable sufferers in our randomized first-line RAS-mutated mCRC CRDF-004 trial,” stated Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.
“Our information reveals an goal response charge of 64% in sufferers receiving the 30 mg dose of onvansertib together with customary of care, considerably larger than the 33% goal response charge noticed within the management arms of normal of care alone. As well as, as could be seen within the spider plots, we’re observing deeper tumor response in sufferers receiving the 30mg dose of onvansertib in comparison with these receiving the 20mg dose with related security profiles for each doses.”
Worth Motion: CRDF inventory was buying and selling 52% larger to $3.71 on the final verify on Tuesday.
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