Press Releases April 21, 2026 10:00 AM

Cardiff Oncology to Present Updated Phase 2 Data of Onvansertib in First-Line RAS-Mutated mCRC in a Rapid Oral Session at ASCO 2026

Cardiff Oncology to Present Promising Phase 2 Onvansertib Data for RAS-Mutated Metastatic Colorectal Cancer at ASCO 2026

By Derek Hwang CRDF

Cardiff Oncology announced it will present updated interim results from its Phase 2 trial evaluating onvansertib in combination with standard chemotherapy regimens for first-line treatment of RAS-mutated metastatic colorectal cancer. The presentation at ASCO 2026 underscores onvansertib's potential as a novel oral PLK1 inhibitor addressing a significant unmet need in oncology treatment.

Cardiff Oncology to Present Updated Phase 2 Data of Onvansertib in First-Line RAS-Mutated mCRC in a Rapid Oral Session at ASCO 2026
CRDF

Key Points

  • Cardiff Oncology's Phase 2 trial (CRDF-004) tests onvansertib plus standard chemotherapy and bevacizumab in first-line RAS-mutated metastatic colorectal cancer patients.
  • Onvansertib is a targeted oral PLK1 inhibitor under development for multiple cancers including colorectal, pancreatic, lung, breast cancers, and leukemia.
  • Presentation at a major oncology conference (ASCO 2026) could validate clinical progress and increase visibility among clinicians and investors.

SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced it will present updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The data will be reviewed in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2 in Chicago.

Rapid Oral Presentation Details:

Abstract Title: Onvansertib plus standard-of-care chemotherapy plus bevacizumab in first-line RAS-mutated metastatic colorectal cancer (mCRC): Interim results from the phase 2 randomized CRDF-004 trial
Abstract Number: 3510  
Session Title: Gastrointestinal Cancer—Colorectal and Anal 
Session Date and Time: June 2, 2026, 8:00-9:30 AM CDT  

The abstract will be publicly available on Thursday, May 21, 2026 on ASCO’s website, and the presentation will be made available on the Scientific Publications page of the Company’s website following its presentation.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Cardiff Oncology, Inc. 
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements 
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact: 
Candice Masse 
astr partners 
[email protected]

Media Contact: 
Amy Bonanno 
Lyra Strategic Advisory 
[email protected]


Risks

  • Clinical trial results remain interim and may not predict final efficacy or safety outcomes, creating uncertainty for regulatory approval and commercial success.
  • Potential side effects or safety issues could arise, possibly delaying or halting drug development.
  • Market competition in oncology drugs and uncertainties around reimbursement by payers and insurers could impact future sales and profitability.

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