Small Cap-Cardiff Oncology Outlines Data From Discontinued Colorectal Cancer Trial, Stock Soars

Cardiff Oncology Inc CRDF provided a clinical update on the first release of data from its ONSEMBLE trial of onvansertib in combination with FOLFIRI/bev in patients with second-line RAS-mutated metastatic colorectal cancer (mCRC).

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 before 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.

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 the 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. 

Onvansertib (all doses) + SoC in 15 patients showed Objective Response Rates of 50% (2 of 4) in Bev naïve patients, 0% (0 of 11) in Bev exposed patients, and in all patients 13% (2 of 15).

No clinical responses were observed in patients who received standard of care with FOLFIRI/bev or were previously exposed to Bev.

The combination of onvansertib with SoC FOLFIRI/bev was well-tolerated, and no major/unexpected toxicities were seen.

Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments at the end of 2023, and it is expected to provide a cash runway into the third quarter of 2025.

Price Action: CRDF shares are up 37.60% at $2.43 on the last check Friday.

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