Reports Q1; Ph2 Data Update At ASCO, FDA Aligned On Ph3

研报英文原文证据摘录

Reports Q1; Ph2 Data Update At ASCO, FDA Aligned On Ph3

TD Cowen Cardiff Oncology

Global Research May 14, 2026

Investment Summary

Cardiff's sole asset onvansertib is a selective PLK1 inhibitor in clinical development

for KRAS-mutant mCRC. Predecessor PLK1 inhibitors have been pursued in the clinic

for the treatment of various cancers, though none have yielded a compelling

risk/benefit profile to date. Onvansertib was designed to be highly selective against

PLK1, be orally delivered, and to have a shorter half-life (~24h) vs. other PLK1

inhibitors. In July 2019, Cardiff began a Ph. Ib/II trial of onvansertib in combination

with FOLFIRI + bevacizumab as 2L therapy in patients with KRAS-mutant mCRC. As of

Sept 2022, the study had shown an ORR of 35% (n=17/48) among evaluable patients

with a mPFS of 9.3 months and an ORR of 34% in the RP2D cohort. The current 34-

35% ORR is greater than would be typically expected with 2L FOLFIRI + bev alone.

Given the especially strong responses observed in bev naive 2L patients, Cardiff

announced the decision to halt development in 2L and pursue a new lead program in

1L RAS+ CRC. A Ph II trial (CRDF-004) is now underway. In December 2024, Cardiff

reported positive interim data from the CRDF-004 Ph II trial in which onvansertib

treated groups achieved greater ORR vs. SOC (57% vs. 33%) with largely consistent

results across subgroups. In July 2025, the ORR vs SOC for the 30mg onvansertib

group achieved an ORR benefit of 19% (49% vs 30%). As of January 2026, updated

findings from study had shown an ORR of 72% (n=13/18) among patients who

received 30mg onvasertib + FOLFIRI/bev compared to 42% (8/19) who received

FOLFIRI/bev alone. Cardiff has selected the 30mg onvansertib dose + FOLFIRI/bev as