Cardiff Oncology (CRDF) Status update summary

Key clinical results and data insights

• 30 mg onvansertib plus FOLFIRI-BEV achieved a 72.2% ORR, a 30-point improvement over control, with median PFS not reached and durable responses beyond 15-18 months as of March 2026 data cut.

• Efficacy and PFS benefits were consistent across all subgroups, including difficult-to-treat populations, with no new safety signals and tolerability comparable to standard regimens.

• The 20 mg dose was active but less effective than 30 mg, with dose-dependent trends in ORR and PFS; 30 mg selected for phase III.

• Addition of onvansertib to FOLFOX-BEV did not yield meaningful improvements, attributed to mechanistic differences between irinotecan and oxaliplatin backbones.

• Several patients in the 30 mg arm achieved deep responses, with some proceeding to curative surgery, highlighting potential for long-term benefit.

Regulatory and development updates

• Successful end of phase II FDA meeting aligned on phase III design (CRDF-005), targeting both accelerated approval (ORR) and full approval (PFS) with ~640 patients.

• Phase III will randomize patients to 30 mg onvansertib plus FOLFIRI-BEV vs. FOLFIRI-BEV alone, with endpoints including ORR, PFS, duration of response, and OS.

• FDA requires full enrollment for accelerated approval consideration, but not full readout; trial powering is conservative to maximize success probability.

• Pending funding, phase III initiation activities are expected late this year or early next year; ongoing patent dispute is not expected to impact trial start.

• Phase 2 trial enrolled 110 patients across six arms, assessing safety, efficacy, and pharmacokinetics.

Safety and tolerability

• No unexpected, overlapping, or new toxicities observed with onvansertib added to FOLFIRI/bev or FOLFOX/bev.

• Adverse events were consistent with background therapy; no new safety signals identified.

• Grade 3 or higher adverse events were infrequent, with neutropenia being the most common.