Cardiff Oncology rises (CRDF +24.4%) on clinical data that further demonstrates the safety, efficacy and durability of response of onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC). Data were presented at the European Society of Medical Oncology Virtual Congress.
Data demonstrated clinical benefit and durability of response to treatment, with confirmed PRs and patients exceeding one year on treatment without disease progression.
10 of 11 (91%) patients achieved disease control with only 1 patient progressing in <6 months while on treatment. 5 patients achieved a partial response (PR) including 4 patients with confirmed PR with 1 patient going on to curative surgery; 1 patient with an initial PR went off study prior to confirmatory scan due to non-treatment related event.
73% of the patients demonstrated durable response ranging from 6 to >12 months, and 4 patients remain on treatment.
On the safety front, Onvansertib + FOLFIRI/bevacizumab was safe and well tolerated with ~9% of adverse events as severe/serious, none attributable to onvansertib and all being resolved within 2.5 weeks.
The first two onvansertib dose levels (12 and 15 mg/m2) have been cleared for safety; four patients have been treated at the third dose level (18 mg/m2) and two more will be enrolled.
No major or unexpected toxicities have been attributed to onvansertib.
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