Cardiff Oncology, Inc. (NASDAQ: CRDF) witnessed a remarkable surge of 64.87% in its stock price during the last trading session, reaching a closing value of $2.91. This dramatic increase was triggered by the release of a significant clinical trial update by Cardiff Oncology.
The update unveiled key insights from the Phase 2 ONSEMBLE trial, which focused on second-line treatment for RAS-mutated metastatic colorectal cancer (mCRC). Although the trial was terminated due to Cardiff Oncology’s strategic pivot towards a first-line mCRC program, it enrolled 23 patients across three arms before halting new enrollments.
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Notably, all 23 patients continued treatment according to the trial protocol. The data from the ONSEMBLE trial echoed the promising efficacy findings of onvansertib observed in earlier trials, particularly among patients who were naïve to bevacizumab (bev). The combination of onvansertib with standard of care demonstrated objective responses exclusively in bev-naïve patients, indicating potential efficacy and tolerability benefits.
The decision to shift focus towards first-line RAS-mutated mCRC stemmed from various factors, including the alignment of clinical hypotheses between the first and second-line trials, efficient capital utilization, and FDA recommendations. This strategic redirection underscores Cardiff Oncology’s commitment to addressing critical unmet needs in cancer treatment.
Furthermore, the combination of onvansertib with standard of care FOLFIRI/bev was well-tolerated, with no significant unexpected toxicities observed. Although two cases of Grade 4 neutropenia were reported among patients receiving a specific dosage, both patients recovered swiftly after discontinuation of treatment, highlighting the manageable safety profile of the combination therapy.
In mid-2024, Cardiff Oncology anticipates sharing the topline results of CRDF-004 in a bid to further understand how onvansertib might improve outcomes for patients with metastatic cancer. The recent clinical trial update from Cardiff Oncology highlights the company’s progress in advancing colorectal cancer therapies.
Cardiff Oncology remains poised to make significant contributions to cancer treatment paradigms thanks to its promising efficacy and safety data, combined with strategic decisions guided by regulatory recommendations.
