Promising data for onvansertib in combination with standard-of-care  

Colorectal cancer

Findings from Cardiff Oncology’s Phase Ib portion of the Phase Ib/II study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) have been published in 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 tumours 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 tumours. Additional data from the full Phase Ib/II 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 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 Ib 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 Ib 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 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 Ib/II data from all 68 patients in the study. The data from this Phase Ib/II study serves as the foundation for our CRDF-004 first-line study in RAS-mutated mCRC, which is now open for enrollment at multiple centres.” 

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