On September 17, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response of onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC) patients at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cardiff Oncology, SEP 17, 2020, View Source [SID1234565291]).

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"We are pleased to observe the clinical benefit and durability of response to treatment, with confirmed PRs and patients exceeding one year on treatment without disease progression," said Daniel H. Ahn, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona. "The addition of onvansertib to standard-of-care shows promise as a novel second-line option for patients with difficult-to-treat KRAS-mutated mCRC. A critical unmet need exists for these patients, as second line treatment has a relatively low response rate and generally confers a poor prognosis."

Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology added, "As we continue to advance our lead clinical program in KRAS-mutated mCRC, we are highly encouraged by the efficacy signal in our ongoing trial. Our analysis of changes in plasma KRAS mutation levels, from baseline to the end of cycle 1 of treatment, appears to be predictive of subsequent tumor shrinkage and may prove to be a useful clinical tool to quickly assess patient response to treatment with onvansertib."
Highlights of the ESMO (Free ESMO Whitepaper) Poster Presentation:

•10 of 11 (91%) patients achieved disease control (SD – stable disease plus PR – partial response) with only 1 patient progressing in <6 months while on treatment
•5 (45%) patients achieved a partial response (PR); 4 patients had a confirmed PR with 1 patient going on to curative surgery; 1 patient with an initial PR went off study prior to confirmatory scan due to non-treatment related event
•8 of 11 (73%) patients demonstrated durable response ranging from 6 to >12 months, and 4 patients remain on treatment

Biomarker Analyses:
•All 5 PRs were associated with different KRAS mutation variants, including the 3 most common that comprise nearly 80% of mutations in CRC
•Patients achieving a PR showed the greatest decreases in plasma KRAS mutation levels (ranging from -78% to -100%) after one cycle of therapy

Safety:
•The first two onvansertib dose levels (12 and 15 mg/m2) have been cleared for safety; four patients have been treated at the third dose level (18 mg/m2) and two more will be enrolled
•Onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated with only 9% of AEs being grade 3 or 4; none being attributed to onvansertib and all being resolved within 2.5 weeks
•No major or unexpected toxicities have been attributed to onvansertib

The poster presented as part of the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 is available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 1b/2 Trial of Onvansertib in Metastatic KRAS-mutated Colorectal Cancer
Cardiff Oncology’s ongoing KRAS-mutated metastatic colorectal cancer clinical trial is a single-arm Phase 1b/2 study assessing the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab in second line KRAS-mutated metastatic colorectal cancer. Trial participants are treated with onvansertib on Days 1-5, and FOLFIRI and bevacizumab on Day 1, of 14-day treatment courses. Primary outcome measures include safety and tolerability assessments. Secondary outcome measures include preliminary efficacy determined by radiographic scans every 8 weeks and reduction in KRAS mutant allelic burden evaluated by liquid biopsy. The trial is being conducted at the USC Norris Comprehensive Cancer Center and the Mayo Clinic Cancer Centers. For more information on the trial, please visit View Source