Cardiff says onvansertib update shows edge in mCRC ahead of 1L data reveal

01 Mar 2024
firstwordpharma.com
Phase 2Clinical Result
Shares in Cardiff Oncology opened 41% higher on Friday after the company disclosed updated clinical data that it says continue to support the efficacy of adding onvansertib (PCM-075) to standard care in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients.
The update stems from the second-line ONSEMBLE trial, a Phase II study that was actually discontinued last August when Cardiff shifted gears and moved to begin testing its oral treatment in first-line patients following feedback from the FDA.
Onvansertib targets PLK1 rather than KRAS mutations directly, but seems to have a synergistic, synthetic lethality-like effect in KRAS-mutant tumours. That lack of specific targeting translates to broader activity than traditional KRAS inhibition, where most clinical candidates target the G12C mutation. Study results unveiled in 2020 showed that five of 11 patients with KRAS-mutant CRC had partial responses following treatment with onvansertib
Cardiff says the ONSEMBLE data provide additional evidence as it pushes the therapy into earlier-stage patients. The Phase II study got underway in March of last year and had randomised 23 mCRC patients with a KRAS or NRAS mutation prior to its early stop a few months later.
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