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Cardiff Oncology Publishes Phase 2 Trial Data on Second-Line Treatment for KRAS-Mutant mCRC in Journal of Clinical Oncology

NextEdge Admin

31 Oct 2024

2 min 13 sec

Journal of Clinical Oncology,PLK1 inhibition

Cardiff Oncology, Inc. , a clinical-stage biotech firm focused on developing therapies targeting PLK1 inhibition for cancer treatment, has announced the publication of results from its Phase 2 trial in the *Journal of Clinical Oncology*. The trial evaluated onvansertib in combination with FOLFIRI and bevacizumab (bev) as a second-line treatment for KRAS-mutant metastatic colorectal cancer (mCRC).

The study showed a remarkable objective response rate (ORR) of 77% and a median progression-free survival (mPFS) of 14.9 months in bev-naïve patients, compared to an ORR of 10% and mPFS of 6.6 months in bev-exposed patients. “It is exciting to see novel therapies that demonstrate clinical activity in KRAS-mutant mCRC, a cancer indication that has lacked new treatments for decades,” said Dr. Heinz-Josef Lenz, USC Norris Comprehensive Cancer Center.

Chief Medical Officer Dr. Fairooz Kabbinavar highlighted that the study’s translational research demonstrated onvansertib’s mechanism in inhibiting the hypoxia pathway, showing strong antitumor effects with bev by inhibiting angiogenesis. This pivotal finding has led Cardiff Oncology to initiate CRDF-004, a Phase 2 randomized trial of onvansertib with standard care (FOLFIRI/bev or FOLFOX/bev) for first-line treatment in RAS-mutant mCRC. Initial data from CRDF-004 is expected in late 2024.

Cardiff Oncology’s lead asset, onvansertib, is being evaluated across multiple cancers, including mCRC, metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC).