Cardiff Oncology Announces Journal of Clinical Oncology Publication of Data from Phase 2 Trial in Second-line KRAS Mutant mCRC
Cardiff Oncology announced the publication of Phase 2 trial data in the Journal of Clinical Oncology, evaluating onvansertib combined with FOLFIRI and bevacizumab for second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC). The study showed significant results, particularly in bevacizumab-naïve patients, demonstrating a 77% objective response rate compared to 10% in bevacizumab-exposed patients. The treatment combination showed a median progression-free survival of 14.9 months in bevacizumab-naïve patients versus 6.6 months in bevacizumab-exposed patients. Based on these findings, the company has initiated CRDF-004, a Phase 2 randomized trial for first-line treatment, with initial data expected in H2 2024.
Cardiff Oncology ha annunciato la pubblicazione dei dati di uno studio di fase 2 nella rivista Journal of Clinical Oncology, che valuta l'uso di onvansertib combinato con FOLFIRI e bevacizumab per il trattamento di seconda linea del cancro colorettale metastatico (mCRC) con mutazione di KRAS. Lo studio ha mostrato risultati significativi, in particolare nei pazienti mai trattati con bevacizumab, dimostrando un tasso di risposta obiettivo del 77% rispetto al 10% nei pazienti già esposti a bevacizumab. La combinazione di trattamenti ha mostrato una sopravvivenza libera da progressione mediana di 14,9 mesi nei pazienti naïve a bevacizumab, rispetto a 6,6 mesi nei pazienti esposti a bevacizumab. Sulla base di questi risultati, la società ha avviato CRDF-004, uno studio di fase 2 randomizzato per il trattamento di prima linea, con dati iniziali attesi nel secondo semestre del 2024.
Cardiff Oncology anunció la publicación de datos de un ensayo de fase 2 en el Journal of Clinical Oncology, evaluando a onvansertib combinado con FOLFIRI y bevacizumab para el tratamiento de segunda línea del cáncer colorrectal metastásico (mCRC) mutante de KRAS. El estudio mostró resultados significativos, particularmente en pacientes que no habían sido tratados con bevacizumab, demostrando una tasa de respuesta objetiva del 77% en comparación con el 10% en pacientes expuestos a bevacizumab. La combinación de tratamientos mostró una supervivencia libre de progresión mediana de 14,9 meses en pacientes no tratados con bevacizumab frente a 6,6 meses en pacientes expuestos. Basado en estos hallazgos, la compañía ha iniciado CRDF-004, un ensayo randomizado de fase 2 para el tratamiento de primera línea, con datos iniciales esperados en la segunda mitad de 2024.
카디프 온콜로지는 KRAS 변이가 있는 전이성 대장암(mCRC)의 2차 치료로 FOLFIRI 및 베바시주맙과 함께 온반세르티브의 평가에 대한 2상 시험 데이터의 발표를 임상 종양학 저널에서 발표했습니다. 이 연구는 특히 베바시주맙을 처음 경험한 환자에서 77%라는 유의한 객관적 반응률을 보여주었고, 이는 베바시주맙에 노출된 환자의 10%에 비해 현저한 결과입니다. 치료 조합은 베바시주맙을 경험하지 않은 환자에서 14.9개월의 중앙 무진행 생존 기간을 보였고, 베바시주맙에 노출된 환자에서는 6.6개월이었습니다. 이러한 결과를 바탕으로, 이 회사는 1차 치료를 위한 2상 무작위 시험인 CRDF-004를 시작했으며, 초기 데이터는 2024년 하반기에 예상됩니다.
Cardiff Oncology a annoncé la publication des données d'un essai de phase 2 dans le Journal of Clinical Oncology, évaluant onvansertib associé à FOLFIRI et bévacizumab pour le traitement de deuxième ligne du cancer colorectal métastatique (mCRC) avec mutation KRAS. L'étude a montré des résultats significatifs, notamment chez les patients n'ayant jamais reçu de bévacizumab, avec un taux de réponse objectif de 77% contre 10% chez les patients exposés au bévacizumab. La combinaison de traitements a donné une survie sans progression médiane de 14,9 mois chez les patients naïfs de bévacizumab, contre 6,6 mois chez ceux exposés à ce traitement. Sur la base de ces résultats, la société a lancé CRDF-004, un essai randomisé de phase 2 pour le traitement de première ligne, avec des données initiales attendues pour le second semestre 2024.
Cardiff Oncology gab die Veröffentlichung der Phase-2-Studienergebnisse im Journal of Clinical Oncology bekannt, in denen onvansertib in Kombination mit FOLFIRI und Bevacizumab als Zweitlinientherapie bei KRAS-mutiertem metastasierenden kolorektalen Krebs (mCRC) evaluiert wird. Die Studie zeigte signifikante Ergebnisse, insbesondere bei Patienten, die noch nie mit Bevacizumab behandelt wurden, mit einer objektiven Ansprechrate von 77% im Vergleich zu 10% bei Patienten, die Bevacizumab ausgesetzt waren. Die Kombinationstherapie zeigte eine mediane progressionsfreie Überlebenszeit von 14,9 Monaten bei Bevacizumab-naiven Patienten, verglichen mit 6,6 Monaten bei bevacizumab-exponierten Patienten. Basierend auf diesen Ergebnissen hat das Unternehmen die Studie CRDF-004 gestartet, eine Phase-2-randomisierte Studie für die Erstlinientherapie, wobei erste Daten für das zweite Halbjahr 2024 erwartet werden.
- 77% objective response rate in bevacizumab-naïve patients
- 14.9 months median progression-free survival in bevacizumab-naïve patients
- Treatment combination demonstrated good tolerability
- Successful transition to first-line treatment development supported by results
- Only 10% objective response rate in bevacizumab-exposed patients
- Lower 6.6 months median progression-free survival in bevacizumab-exposed patients
Insights
The publication of Phase 2 trial results in the prestigious Journal of Clinical Oncology represents significant clinical validation for onvansertib. The 77% objective response rate in bevacizumab-naïve patients is remarkably high for KRAS-mutant metastatic colorectal cancer, where treatment options have remained The median progression-free survival of 14.9 months in this group also suggests meaningful clinical benefit.
The mechanistic insights revealing onvansertib's role in inhibiting the hypoxia pathway and enhancing anti-angiogenic effects provide strong scientific rationale for the first-line positioning. This strategic pivot to first-line treatment, supported by both clinical data and FDA input, significantly expands the potential market opportunity. The upcoming CRDF-004 trial readout in H2 2024 will be crucial, as positive results could position onvansertib as a new standard-of-care option in first-line RAS-mutant mCRC treatment.
This development significantly strengthens Cardiff Oncology's market position in the $10+ billion colorectal cancer therapeutics market. The shift to first-line treatment represents a larger commercial opportunity, as all patients are bevacizumab-naïve and the treatment duration is typically longer in first-line settings. The strong efficacy data in bevacizumab-naïve patients (7.7x higher response rate) provides compelling evidence for payers and potential partners.
The publication in JCO adds credibility and visibility within the oncology community, potentially attracting partnership interest from larger pharmaceutical companies. With positive H2 2024 data, onvansertib could capture significant market share in the RAS-mutant mCRC segment, which represents approximately 45% of all mCRC cases.
- Findings underscore that the combination of onvansertib with FOLFIRI and bevacizumab demonstrates clinical activity and is well tolerated in second-line KRAS-mutant mCRC -
- Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of
- Results from this trial, along with translational studies, supported the transition of clinical development of onvansertib to first-line RAS-mutant mCRC -
- Initial readout from first-line RAS-mutant mCRC CRDF-004 trial expected in H2 2024 -
SAN DIEGO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the publication of data from our Phase 2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab (bev) for the second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC) in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO).
“It is exciting to see novel therapies in development that are well tolerated and demonstrate clinical activity in KRAS mutant mCRC, a cancer indication that has lacked new treatment options for decades,” said Heinz-Josef Lenz, MD, Professor of Medicine, J. Terrence Lanni Chair in Cancer Research, Deputy Cancer Center Director USC Norris Comprehensive Cancer Center, USC Keck School of Medicine and the national principal investigator on this trial. “The
“We are proud to be recognized by this prestigious oncology journal for our groundbreaking clinical and preclinical findings observed when adding onvansertib to the standard of care for KRAS mutant mCRC,” added Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. We are highly encouraged by the clinical results demonstrating a 7.7x higher objective response rate (ORR) in patients who were not previously exposed to bev, and our subsequent discovery of a novel mechanism for onvansertib through our translational work. Collectively, these findings and the support of the FDA led us to shift our clinical development program for onvansertib to the first-line setting where all patients are bev-naïve.”
The results of the published Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and revealed a greater clinical benefit in bev-naïve patients (ORR of
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), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), 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 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; 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 an epidemic or pandemic such as the 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, 2023, 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:
Grace Spencer
Taft Communications
609-583-1151
grace@taftcommunications.com
FAQ
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