CRDF - Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC | Benzinga
- New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients -
- Company discontinued the ONSEMBLE trial in August 2023 to shift focus of clinical development program to first-line RAS-mutated mCRC in agreement with the FDA -
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company's shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company's earlier Phase 1b/2 KRAS-mutated mCRC trial.
"The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting. The only objective responses observed on the trial occurred in bev naïve patients who received onvansertib plus standard of care, and the combination of onvansertib with standard of care was well-tolerated. By moving our lead program to the first-line setting, all patients on the CRDF-004 trial will be bev naïve," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. "Importantly, no responses were observed in bev naïve patients randomized to the control arm, suggesting onvansertib improved the efficacy of standard of care therapy. And similarly, no responses were observed in patients who had received bev as part of their first line therapy in the onvansertib or the control arms, providing further evidence in a randomized setting of onvansertib's potential to improve outcomes for patients when added to standard of care in the first-line setting. We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024."
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 |