Cardiff Oncology Reports Early Onvansertib Monotherapy Activity In Phase 1 CMML Trial Ahead Of ASH 2025 Poster Presentation

Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that clinical data from an investigator-sponsored trial with onvansertib in chronic myelomonocytic leukemia (CMML) will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting.

In this Phase 1 dose escalation trial (N=9), onvansertib as a monotherapy was shown to be relatively well-tolerated, and demonstrated preliminary efficacy in approximately 40% of patients, with one patient having an optimal marrow response at the 9 mg/m2 dose. These results, along with previously announced data from an investigator-sponsored trial in small cell lung cancer, validate onvansertib's single agent activity in both hematologic and solid tumors. Cardiff Oncology is not currently planning to develop onvansertib for CMML.

Poster Details:

Title: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML)

Session-Type: Poster Abstract Session

Speaker: Mrinal Patnaik, MD, MBBS, Mayo Clinic, Rochester, MN, United States

Date: Monday, December 8, 2025 at 6:00-8:00 PM EST

Part of Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster III

The abstract can be found on the ASH Annual Meeting website, https://submit.hematology.org/program/presentation/674309