CRDF - Cardiff Oncology adds 14% on data for lead asset in KRAS-mutated colorectal cancer

Clinical-stage biotech Cardiff Oncology ( NASDAQ: CRDF ) added ~14% in the pre-market trading Monday after the company announced Phase 1b/2 data for its lead asset Onvansertib in patients with KRAS-mutated metastatic colorectal cancer in a second-line setup.

The data featured in a presentation at the European Society for Medical Oncology (ESMO) Congress 2022 included updated data and biomarker analyses from Phase 1b/2 clinical trial for onvansertib plus chemotherapy FOLFIRI and cancer therapy bevacizumab.

As of July 26 data cutoff, the highlights of results indicated that overall response rate (ORR) and median progression-free survival (mPFS) significantly surpassed those seen in historical control studies, the company said.

In an analysis of clinical responses among patients identified as KRAS responders or non-responders, the former group had greater ORR and mPFS than non-responders.

Another ESMO presentation discussed a comparison between KRAS responders and non-responders in CRDF’s Expanded Access Program, which included patients who were ineligible to participate in the Phase 1b/2 trial.

Data as of Aug. 5 indicated that EAP patients who had received colorectal cancer therapy irinotecan demonstrated clinical benefit in response to onvansertib plus FOLFIRI/bevacizumab.

In addition, KRAS responders with previous irinotecan therapy were found to have significantly longer PFS than non-responders.

CRDF is backed by Pfizer ( PFE ) which made $15M equity investment in the company last year .

For further details see: