SAN DIEGO, Calif., April 21, 2026

Cardiff Oncology, Inc. announced it will present updated Phase 2 data for its lead asset onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) at the ASCO Annual Meeting 2026. The data from the CRDF-004 randomized clinical trial reinforce the potential of PLK1 inhibition as a novel therapeutic strategy, highlighting the company’s continued progress in advancing targeted oncology drug development for high unmet need patient populations.

Onvansertib Advances as Targeted PLK1 Inhibitor

Onvansertib is a highly selective, oral inhibitor of Polo-like kinase 1 (PLK1), a key regulator of cell division that is frequently overexpressed in cancer cells, making it an important therapeutic target. The ongoing Phase 2 CRDF-004 trial is evaluating onvansertib in combination with standard-of-care chemotherapy regimens such as FOLFIRI or FOLFOX plus bevacizumab, aiming to enhance treatment response and overcome resistance mechanisms associated with RAS-mutated cancers.

These cancers represent a significant clinical challenge, as patients often exhibit limited responsiveness to existing targeted therapies. The development of onvansertib reflects a precision medicine approach, targeting tumor-specific vulnerabilities to improve outcomes.

Pipeline Development Strengthens Oncology Strategy

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The upcoming ASCO 2026 presentation will feature interim findings from the randomized dose-finding study, offering insights into the drug’s activity, tolerability, and combination potential. While the study focuses on first-line treatment, onvansertib is also being evaluated across multiple tumor types, including pancreatic cancer, small cell lung cancer, triple-negative breast cancer, and hematologic malignancies.

This broad development strategy underscores Cardiff Oncology’s commitment to expanding the therapeutic reach of PLK1 inhibition. By integrating onvansertib into combination regimens, the company aims to maximize clinical benefit and address resistance pathways, which remain a major barrier in oncology treatment.

ASCO 2026 Presentation Marks Key Development Milestone

The presentation at ASCO 2026 represents a critical milestone in the clinical development pathway of onvansertib, providing an opportunity to showcase progress in mid-stage drug development to the global oncology community. The trial’s focus on RAS-mutated mCRC, a population with high unmet medical need, highlights the importance of innovative therapies that can improve treatment efficacy and durability. As one of the leading oncology conferences, ASCO serves as a platform to validate emerging therapeutic approaches and accelerate drug development timelines.

Cardiff Oncology’s continued advancement of onvansertib demonstrates a strategic focus on targeted therapy innovation, combining mechanism-driven drug design with clinical research execution. If successful, onvansertib has the potential to become a differentiated treatment option within the colorectal cancer landscape, addressing a patient population that has historically lacked effective targeted therapies. These developments reinforce the growing importance of biopharmaceutical innovation in oncology, where novel mechanisms and combination strategies are driving the next wave of cancer treatment advancements.

Source: Cardiff Oncology press release