Expert Interview
Discussing Cardiff Oncology’s onvansertib in KRAS-mutated Metastatic Colorectal Cancer
Ticker(s): CRDFAn oncologist with experience in treating KRAS-mutated cancers.
Please describe your clinical practice. How many patients with KRAS positive cancer do you currently manage? What is the standard of care for Metastatic Colorectal Cancer? What percent of patients have a histologically confirmed metastatic and unresectable colorectal carcinoma harboring a KRAS mutation?
Added By: catalin_adminCan you please comment on the Phase 1b/2 Results of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second–Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation?Among patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) in combination with FOLFIRI-bev:12 of 35 (34%) achieved an initial complete response (CR) or partial response (PR)10 of 35 (29%) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)33 of 35 (94%) had a best response of disease control (CR + PR + SD)Objective response rates of 5-13% observed in historical control trials in similar patient populations treated with various different drug combinations, including the standard of care chemotherapy of FOLFIRI with bevacizumab1-4Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2)17 of 48 (35%) achieved an initial CR or PR13 of 48 (27%) have achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)44 of 48 (92%) had a best response of disease control (CR + PR + SD)
Can you please discuss also the many patient discontinuations?1 patient discontinued from the trial prior to confirmatory scan due to an adverse event that was unrelated to treatment (hepatitis B)1 patient went from PR to SD at the confirmatory scan and patient subsequently discontinued from the trial to pursue potentially curative metastasis-directed therapy1 patient went from PR to SD at the confirmatory scan (patient remains on treatment)1 patient has yet to have their confirmatory scan5 of 48 (10%) evaluable patients discontinued therapy to pursue potentially curative metastasis-directed therapy (surgery or microwave ablation), including 2 patients with SD
Patients must have experienced disease progression or treatment intolerance to first-line treatment with fluoropyrimidine and oxaliplatin (FOLFOX or CapeOx) with or without bevacizumab to be eligible for onvansertib. What % of the patients do you think would qualify?
How likely are you to use onvansertib combination therapy in the future?
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