Cardiff Oncology Stock Drops Despite Promising Colorectal Cancer Data

Cardiff Oncology's onvansertib in combination with standard-of-care showed a 59% overall objective response rate in first-line RAS-mutated metastatic colorectal cancer patients. The high dose arm had a confirmed ORR of 49%, compared to 30% in the control arm. The drug was well-tolerated with no major or unexpected toxicities. The company plans to update its first-line mCRC program by Q1 2026. Analysts believe the data justifies further investment and moving forward with a Phase 3 trial.

Title: Cardiff Oncology Reports Positive Data for Onvansertib in First-Line RAS-Mutated Metastatic Colorectal Cancer

Cardiff Oncology, Inc. (Nasdaq: CRDF) has announced positive data from its ongoing CRDF-004 Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial demonstrated a 49% confirmed objective response rate (ORR) in the 30mg onvansertib dose arm versus 30% in the control arm, based on an intent-to-treat population of 110 patients [1].

The data, as of a July 8, 2025 data cut-off, showed a trend favoring the 30mg onvansertib dose arm in terms of progression-free survival (PFS) compared to the control arm. The drug was well-tolerated, with no major or unexpected toxicities observed, and neutropenia being the most common treatment-emergent adverse event associated with onvansertib. The company plans to provide an update on its first-line mCRC program by Q1 2026 [1].

Analysts believe the data justifies further investment and moving forward with a Phase 3 trial. The confirmed ORR of 49% in the high dose arm, compared to 30% in the control arm, indicates significant potential for onvansertib as a novel therapy for the treatment of first-line RAS-mutated mCRC.

References

[1] https://investors.cardiffoncology.com/news-releases/news-release-details/cardiff-oncology-announces-positive-data-ongoing-randomized