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Cardiff’s Move Into First-Line mCRC Backed By Data From Discontinued Study

 
• By Joseph Haas

Based on advice from the FDA, Cardiff is testing its PLK1 inhibitor onvansertib in first-line metastatic colorectal cancer; data from a discontinued second-line trial may support the hypothesis.

Metastatic cancer
Cardiff is working to develop the first new therapy for first-line mCRC in 20 years • Source: Shutterstock

Cardiff Oncology, Inc. expects to release top-line data from a Phase II study of its PLK1 inhibitor onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) around mid-2024, but data from a discontinued study in second-line patients has provided evidence that the theory behind the ongoing trial is sound.

Key Takeaways

  • Cardiff is enrolling a Phase II study in first-line mCRC for its PLK1 inhibitor that it hopes will yield overall response data by mid-2024.

  • If that study succeeds, the firm will move immediately into a Phase III study devised to provide data for accelerated and full approvals, designed in tandem with the FDA

The San Diego biotech has been waging a two-front battle as it tries to make its cash last long enough to prove that its PLK1 inhibitor can boost the effectiveness of standard-of-care therapy in mutated solid tumors. It previously ended plans to develop onvansertib in prostate cancer to focus its funds on proving the drug could benefit second-line, KRAS-mutated mCRC patients

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