Positive Update from Ph 2 Trial of Onvansertib in 1L RAS-mutated mCRC Announced
“These data demonstrate promising enhanced benefits of onvansertib when combined with FOLFIRI/bev in RAS-mutated mCRC patients,” said Mani Mohindru, PhD, interim Chief Executive Officer. “We observed a consistent, dose-dependent treatment benefit across multiple measures of efficacy, including achieving statistical significance for PFS compared to SoC even with relatively small patient numbers. The 30 mg onvansertib–FOLFIRI/bev arm outperformed both SoC arms with no significant additive toxicity, supporting findings from our previous Phase 2 trial in second-line RAS-mutated mCRC. While we continue to review data from the ongoing trial, our plan is to rapidly move forward with the onvansertib 30 mg dose in combination with FOLFIRI/bev and we believe confirmatory data from a registrational trial has the potential to make this regimen a new SoC for 1L treatment of RAS-mutated mCRC.”
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