Cardiff Oncology Announces New Data from Phase 1b/2 Trial in KRAS-mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival
- 8 of 19 (42%) patients treated per protocol at the recommended Phase 2 dose (RP2D) of onvansertib 15 mg/m2?who were evaluable for disease response as of the data cut-off achieved a partial response (PR). Historically, objective response rates (ORR) of 5-13% have been reported in a similar patient population treated with standard of care chemotherapy1-4
- 12 of 32 (38%) patients evaluable for response as of data cutoff date across all dose levels achieved a PR
- Median progression-free survival (mPFS) across all response-evaluable patients is 9.4 months and has not yet been reached in those treated per protocol at the RP2D. Historically, mPFS of ~4.5-5.7 months has been reported in a similar patient population treated with standard of care chemotherapy1-4
- The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated
- Management is hosting key opinion leader webinar to discuss data today at?4:00 PM ET; a replay of the webinar will be available on the events section of the Cardiff Oncology website for 90 days
- Patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) across both Phase?1b?and Phase 2:
- 8 of 19 (42%) achieved an initial partial response (PR) as of the data cutoff date
- 7 of 19 (37%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date)
- Objective response rates observed in historical control trials in similar patient populations treated with standard of care are 5-13%1-4
- Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2) across both phases of the study
- 12 of 32 (38%) achieved an initial PR as of the data cutoff date
- 10 of 32 (31%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date)
- mPFS has not yet been reached in patients treated per protocol at the RP2D
- mPFS across all response-evaluable patients (n = 32) is 9.4 months (95% confidence interval: 7.8 ? not yet reached)
- mPFS of ~4.5-5.7 months has been reported in trials used as historical controls1-4
- Partial responses (PRs) were observed across different KRAS mutation variants, including the 3 most common observed in colorectal cancer (G12D, G12V, G13D)
- Patients achieving a best response of PR showed the greatest decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle (28 days) of therapy
- The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 10% (49/490) of reported treatment-emergent adverse events (TEAEs) being G3/G4
- Most reported treatment-related adverse events (TRAEs) were manageable and reversible with supportive care
- Giessen?et al., Acta Oncologica 2015, 54: 187-193
- Cremolini et al., Lancet Oncol 2020, 21: 497?507
- Antoniotti et al., Correspondence Lancet Oncol?June 2020
- Bennouna et al., Lancet Oncol 2013; 14: 29?37