Cardiff Oncology Announces Publication of Data from Phase 1b study in second-line KRAS-mutated mCRC in Clinical Cancer Research

Rhea-AI Summary

Cardiff Oncology, Inc. announced the publication of findings from the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). The results highlight the safety and promising efficacy of onvansertib in combination with standard-of-care chemotherapy+bevacizumab. The study revealed an improved objective response rate and median progression-free survival compared to historical controls, demonstrating efficacy across multiple KRAS mutations. The company has also received agreement from the US FDA to initiate a first-line trial in RAS-mutated mCRC.

Medical Research Analyst

The recent publication detailing the Phase 1b study findings for onvansertib in the treatment of KRAS-mutated metastatic colorectal cancer (mCRC) is significant for the medical community and investors alike. The emphasis on the safety and efficacy of the drug, particularly in combination with standard-of-care treatments, is a critical factor in its potential market acceptance. As mCRC patients with KRAS mutations have limited treatment options, the development of onvansertib could represent a substantial advancement in oncology therapeutics.

From a research perspective, the reported improvement in objective response rate and median progression-free survival compared to historical controls suggests that onvansertib could become a key player in the second-line treatment landscape for this patient group. The indication that it is effective across various KRAS mutations enhances the drug's market potential, as it could address a broader segment of the mCRC population.

Furthermore, the decision to initiate a first-line trial underscores confidence in the drug's prospects and could significantly expand its addressable market if successful. The upcoming presentation of the full Phase 1b/2 data at the AACR Annual Meeting will be closely watched for further validation of these findings and could impact Cardiff Oncology's stock valuation and investor sentiment.

Oncology Doctor

Onvansertib's role as a PLK1 inhibitor is particularly noteworthy in the context of mCRC treatment. PLK1 is a protein that plays a pivotal role in cell division and its inhibition can lead to cell cycle arrest and apoptosis in cancer cells. This mechanism of action, combined with the standard chemotherapy regimen FOLFIRI and the angiogenesis inhibitor bevacizumab, appears to have resulted in a more effective attack on cancer cells, as evidenced by the reported outcomes.

The clinical relevance of these findings cannot be understated, as KRAS mutations have been historically challenging to target effectively. The study's suggestion of an improved safety profile is also encouraging, as treatment tolerability is a key concern in cancer therapy, affecting patient quality of life and treatment adherence. The transition to investigating onvansertib in a first-line setting could, if successful, alter the standard-of-care for RAS-mutated mCRC and potentially improve survival outcomes for these patients.

Market Research Analyst

Cardiff Oncology's strategic pivot to initiate a first-line trial based on the Phase 1b study results is a calculated move that could capture market share in the oncology sector. The published data in a peer-reviewed journal adds credibility and visibility to the drug's profile, which is essential for market adoption and can influence stakeholder confidence.

It is important to note that the market for mCRC treatments is competitive, with several established players and emerging therapies. The ability of onvansertib to demonstrate efficacy across multiple KRAS mutations could differentiate it from other therapies and provide a competitive edge. However, it is essential for Cardiff Oncology to continue demonstrating robust clinical outcomes and to navigate the regulatory landscape effectively to secure FDA approval.

The stock market's response to these developments will likely hinge on the detailed data presented at the AACR meeting and subsequent clinical trial results. Positive outcomes could lead to increased investor interest and potentially higher stock prices for Cardiff Oncology. Conversely, any setbacks in clinical development could have a negative impact on investor sentiment.

- Findings from the Phase 1b portion of company's Phase 1b/2 study in second-line KRAS-mutated mCRC highlight the safety and promising efficacy of onvansertib in combination with standard-of-care -

- These peer-reviewed published data are part of the Phase 1b/2 data Cardiff Oncology announced in August 2023 and informed the shift to investigation in first-line in RAS-mutated mCRC (CRDF-004)-

SAN DIEGO, Jan. 17, 2024 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) disclosed by Cardiff Oncology in August 2023 have been published in the peer-reviewed journal Clinical Cancer Research, a journal of the American Association for Cancer Research.

The publication underscores the safety profile of onvansertib when combined with the standard-of-care (SoC) chemotherapy+bevacizumab. The results show that the combination has a lasting response, indicating its tolerability and efficacy in treating mCRC patients whose tumors harbor various KRAS mutations.

Onvansertib is a highly specific Polo-like kinase 1 (PLK1) inhibitor that has shown tolerability as a single agent and in combination with multiple chemotherapies in various solid tumors. Additional data from the full Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated mCRC will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April 2024. These compelling insights, along with the agreement from the US FDA, led to Cardiff Oncology's decision to initiate a first-line trial (CRDF-004) in RAS-mutated mCRC.

"Our groundbreaking Phase 1b study targeted the KRAS-mutated mCRC patient population that has limited effective treatment options, and for whom there has been no new targeted therapy approved in decades. The Phase 1b study revealed the safety and enhanced efficacy of integrating onvansertib, an oral PLK1 inhibitor, with SoC FOLFIRI+bevacizumab in KRAS-mutated second-line mCRC patients," said Dr. Fairooz Kabbinavar MD, FACP, Chief Medical Officer of Cardiff Oncology and one of the article's lead authors. "Our study showed an improved objective response rate and median progression-free survival compared to historical controls. Encouragingly, the FOLFIRI+bevacizumab+onvansertib combination demonstrated efficacy across multiple KRAS mutations. Our upcoming presentation at AACR will showcase the full Phase 1b/2 data from all 68 patients in the study. The data from this Phase 1b/2 study serves as the foundation for our CRDF-004 first-line study in RAS-mutated mCRC, which is now open for enrollment at multiple centers."

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. 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; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, 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 any precision medicine therapeutics 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, 2022, 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.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com 

Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com 

Media Contact:
Richa Kumari
Taft Communications
551-344-5592
richa@taftcommunications.com 

 

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SOURCE Cardiff Oncology, Inc.

What is the focus of Cardiff Oncology's Phase 1b/2 study?

The study focuses on the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).

What is onvansertib?

Onvansertib is a highly specific Polo-like kinase 1 (PLK1) inhibitor.

What are the key findings of the Phase 1b portion of the study?

The study revealed the safety and promising efficacy of onvansertib in combination with standard-of-care chemotherapy+bevacizumab, demonstrating improved objective response rate and median progression-free survival.

What is the significance of the upcoming presentation at AACR?

The presentation will showcase the full Phase 1b/2 data from all 68 patients in the study.

What is the status of the CRDF-004 first-line study?

The study is now open for enrollment at multiple centers.