Cardiff Oncology, Inc. Announces New Data from Phase 1B/2 Trial in KRAS-Mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival
September 08, 2021 at 09:01 pm
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Cardiff Oncology, Inc. announced new data from its lead clinical program evaluating onvansertib in combination with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). Efficacy data in patients evaluable for disease response as of data cutoff date (July 2, 2021): 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%. 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). Median progression free survival (mPFS): 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) and mPFS of approximately 4.5-5.7 months has been reported in trials used as historical controls. Biomarker data as of data cutoff date across all patients: 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 greater decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle (28 days) of therapy. Safety data as of data cutoff date across all patients: 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.
Cardiff Oncology, Inc. is a clinical-stage biotechnology company. It is leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the unmet medical need. It is focused on clinical programs in indications, such as RAS-mutated metastatic colorectal cancer (mCRC), and in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC). Its lead drug candidate, Onvansertib, is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life. It has five ongoing and planned clinical trials of onvansertib: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, one trial (CRDF-001) in second-line treatment in patients with mPDAC, and three investigator-initiated trials in first line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
Cardiff Oncology, Inc. Announces New Data from Phase 1B/2 Trial in KRAS-Mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival