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Cardiff Oncology Data Continues to Demonstrate Efficacy, Durability and Safety of Onvansertib in Patients with Difficult-to-Treat Relapsed/Refractory AML
- Phase 1b: 7 (33%) of evaluable patients achieved an objective response, with a complete response (CR/CRi) in 5 (31%) patients treated at the four highest
About this update from Cardiff Oncology, Inc.
[{"type":"text","content":"- Phase 1b: 7 (33%) of evaluable patients achieved an objective response, with a complete response (CR/CRi) in 5 (31%) patients treated at the four highest onvansertib dose levels\n - 3 (60%) of the 5 patients remain on treatment with durable response demonstrated: 6, 12 and 15 months, respectively, following the initial response; 1 patient went on to transplant\n - Phase 2: Of the 7 patients having completed 1 cycle of treatment, 2 (28%) achieved an objective response; 1 had a complete response (CR) and significant decrease in ctDNA\n - Response biomarkers show that decreases in ctDNA after 1 cycle of treatment are highly predictive of clinical response\n - Onvansertib in combination with decitabine continues to be a safe and well-tolerated treatment regimen\n\n\nSAN DIEGO, June 15, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, today announced presentation of final results of its Phase 1b study, and preliminary positive data from its Phase 2 study, in relapsed or refractory acute myeloid leukemia (AML). The data was presented as a virtual poster presentation at the European Hematology Association (EHA) annual conference. \n\n \n \n \n \n \n \n\n \nThe presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.\nThe EHA poster presentation is available for download from the Scientific Presentations page on the Cardiff Oncology website at https://cardiffoncology.com/scientific-presentations/.\n\"While the trial is still ongoing, we are encouraged by the efficacy we are seeing thus far in patients with relapsed/refractory AML, particularly the durability of response observed in some patients,\" said Dr. Amer Zeidan, lead investigator and associate professor of Medicine at the Yale School of Medicine, and the medical director of Hematology Early Therapeutics Research at Yale Cancer Center. \"As we continue with enrollment and assessment of efficacy in the Phase 2 portion of the tria...