Cardiff Oncology Inc. (NASDAQ: CRDF) has announced the latest data from its clinical program investigating the combination of onvansertib with the standard of care bevacizumab/FOLFIRI for second-line KRAS-mutated metastatic colorectal cancer patients treatment.
New data shows ovansertib’s potential in KRAS-mutated mCRC
Chief Medical Officer Katherine L. Ruffiner said, “Our Phase 1b/2 trial continues to generate data suggesting that the addition of onvansertib to SOC results in an objective response rate and median progression-free survival that substantially exceed those previously achieved with SOC alone. Radiographic responses have been observed across multiple KRAS mutation variants, which speaks to a key advantage of onvansertib over competing agents targeting individual mutations. These impressive results, which have remained consistent across both academic and community trial sites, highlight the potential for onvansertib to address the unmet need for new second-line therapeutic options to treat patients with KRAS-mutated mCRC.”
The company indicated that 8 out of the 19 patients enrolled per protocol for the recommended second phase dose of ovansertib 15 mg/m2 who were assessable for disease response attained partial response. In addition, in the past objective response rates of 5-13% have been observed in the same patient population that received standard of care therapy.
Onvansertib combination well tolerated
Patients that attained partial response demonstrated an increased decline in plasma KRAS mutant allelic frequency after 28 days of therapy. Onvansertib’s combination with bevacizumab was well tolerated, with 10% of the reported treatment –emergent adverse events being G3/G4. Most importantly, treatment-related adverse events were reversible and manageable through supportive care.
CEO Mark Erlander said, “The strong signal of efficacy and favorable tolerability profile observed in this trial bodes well not only for our lead mCRC program, but for each of our KRAS-focused clinical programs. The meaningful improvements we are seeing in treatment response relative to historical controls demonstrate the value of combination therapy and support the synergistic effect observed preclinically when onvansertib is added to standard-of-care irinotecan and 5-FU (FOLFIRI).”