Cardiff Oncology (CRDF) Reports Onvansertib Phase 1b/2 Data Demonstrates Robust Response to Treatment and Progression-Free Survival in KRAS-Mutated mCRC

April 12, 2021 6:01 AM EDT

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Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, today announced data from its ongoing Phase 1b/2 trial that demonstrate the continued robust patient response to treatment with onvansertib and progression-free survival when combined with standard-of-care therapy in second line KRAS-mutated metastatic colorectal cancer (mCRC).

Patients enrolled in the ongoing Phase 1b/2 trial receive onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab). The overall response rate (ORR) in the trial is 39% to-date, and onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib. The median progression free survival (mPFS) of evaluable patients is 9.4 months. This represents an increase over the mPFS observed in a systematic literature-based analysis of second line mCRC clinical trial data from 23 randomized trials including a total of ~10,800 patients (mPFS of 4.5 months)1 and the 5.7-month mPFS observed in the pivotal trial that supported the regulatory approval of FOLFIRI plus bevacizumab in second line mCRC2.

"As we have continued to collect data from this ongoing trial, we have consistently seen an impressive and durable response to treatment, and a favorable safety and tolerability profile," said Daniel H. Ahn, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona. "Notably, the ORR and mPFS observed in the trial compare very favorably to what has been seen historically in second line mCRC patients. These promising results highlight the potential of onvansertib to address the unmet needs in mCRC, and I look forward to discussing them in detail during Cardiff Oncology's upcoming key opinion leader webinar."

Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology added, "We are very pleased with the results to-date from our Phase 1b/2 mCRC trial. In addition to continuing to show a consistent and robust response rate, we have also reported intriguing biomarker analyses highlighting the potential of plasma KRAS mutant allelic frequency as a tool to predict patient response to onvansertib. We look forward to providing results from the Phase 2 trial later this year."

Highlights from the updated data announcement include:


  • 7 of 18 (39%) evaluable patients achieved a partial response (PR); 4 patients had a confirmed PR with 1 patient going on to curative surgery; 1 patient with a non-confirmed PR went off study following PR prior to confirmatory scan due to a treatment-unrelated adverse event; 2 patients with non-confirmed PRs await results from confirmatory scans
  • Evaluable patients have a mPFS of 9.4 months (95% confidence interval: 7.85 months – not reached)
  • 7 patients remain on treatment to-date


  • Clinical responses were observed across different KRAS mutations, including the 3 most common in colorectal cancer (G12D, G12V, G13D)
  • The greatest decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR
  • All 7 patients with a PR had a >75% decrease in KRAS MAF after one cycle of treatment


  • Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib

Key Opinion Leader Webinar

The updated Phase 1b/2 mCRC trial data will be presented during a key opinion leader (KOL) webinar taking place today, April 12, 2021 at 11:00 a.m. ET. The webinar will feature KOLs Dr. Ahn (Mayo Clinic Arizona), and Dr. Sharma (START Midwest), who will also discuss the current treatment landscape and unmet medical need in KRAS-mutated mCRC and observations from the EAP evaluating onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated mCRC.

During the webinar, Dr. Erlander will also present a corporate update and outlook for the year. Dr. Erlander and Drs. Sharma and Ahn will be available to answer questions following the conclusion of the formal presentations.

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