Cardiff Oncology announces results from trials in mPDAC and SCLC

Cardiff Oncology announced positive clinical data with onvansertib monotherapy and combination therapy in our ongoing trials in metastatic pancreatic ductal adenocarcinoma, or mPDAC, and small cell lung cancer, or SCLC, as well as plans for a mPDAC first-line investigator-initiated trial, or IIT, of the combination of onvansertib plus standard-of-care, or SoC. Data from the ongoing Phase 2 open-label trial of onvansertib combined with nanoliposomal irinotecan, leucovorin, and 5-FU in patients with second-line mPDAC demonstrated an objective response rate, or ORR, of 19% and median progression-free survival (mPFS) of 5.0 months as of the data cutoff of September 13. Historical control trials in similar patient populations have shown an ORR of 7.7% and mPFS of 3.1 months with SoC. The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and is currently enrolling at the Oregon Health & Science University Knight Cancer Institute. Two patients have been enrolled to date. One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response. The next trial in mPDAC will be a new Phase 2 investigator-initiated trial at OHSU Knight Cancer Institute in mPDAC in the first-line setting. There are two cohorts in this trial. In cohort 1, patients will receive the combination of onvansertib with SoC. In cohort 2, patients will receive 10 days of onvansertib monotherapy followed by onvansertib + SoC to identify biomarkers that predict response to onvansertib.