Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC - Seite 2

Data Release from the Phase 2 randomized second-line ONSEMBLE trial in RAS-mutated mCRC

In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC. This decision was driven by the fact that both trials essentially test the same clinical hypothesis, the importance of deploying the company's capital efficiently, and the FDA's suggestion that Cardiff Oncology consider focusing on the first-line RAS-mutated mCRC setting given the lack of any new therapies approved in this large cancer indication in the last 20 years.

At the time enrollment was discontinued, the ONSEMBLE trial had randomized 23 patients across three arms including a control arm of standard of care (SoC) FOLFIRI+bev, an experimental arm with onvansertib (20mg dose) added to SoC FOLFIRI+bev, and an experimental arm with onvansertib (30mg dose) added to SoC FOLFIRI+bev. The trial included patients with mCRC who had a documented KRAS or NRAS mutation and had previously received one prior chemotherapy regimen with or without bev in the first-line metastatic setting.

Patient enrollment populations
Intent to treat population	23 patients
Patient randomized to control arm withdrew consent prior to initial dose	1 patient
Patient population evaluable for safety	22 patients
Patient randomized to control arm withdrew consent prior to post-baseline scan	1 patient
Patient population evaluable for efficacy	21 patients

Efficacy Data – Objective Response Rates (ORR)
	Bev Naïve patients	Bev Exposed patients	All patients
FOLFIRI/bev (SoC alone); N=6	0% (0 of 3)	0% (0 of 3)	0% (0 of 6)
Onvansertib 20 mg + SoC; N=8	50% (1 of 2)	0% (0 of 6)	13% (1 of 8)
Onvansertib 30 mg + SoC; N=7	50% (1 of 2)	0% (0 of 5)	14% (1 of 7)
Onvansertib (all doses) + SoC; N=15	50% (2 of 4)	0% (0 of 11)	13% (2 of 15)
The two partial responses were confirmed on the patients’ subsequent scans.