A phase II trial of ficlatuzumab (AV-299), an investigational HGF inhibitory antibody, in patients with relapsed and refractory acute myeloid leukemia (AML) joins the growing list of clinical trials halted due to the coronavirus disease 2019 (COVID-19) pandemic.
Developers AVEO and Biodesix announced in a press release that the CyFi-2 trial (NCT04100330) would be discontinued because shifts in efforts toward the COVID-19 pandemic at clinical trial sites are preventing investigators from being able to complete the study within the shelf-life of the drug’s current supply.

The trial was discontinued before patient enrollment began.

“While this is a difficult decision, as we remain optimistic about the potential of ficlatuzumab in AML, we believe it is necessary in light of the COVID-19 pandemic and its effect on the states where the CyFi-2 study was to take place,” said Michael Bailey, president and CEO of AVEO, in the press release.

Ficlatuzumab is an HGF inhibitory antibody that binds to the HGF ligand and blocks the MET tyrosine kinase receptor. AVEO and Biodesix entered into a worldwide agreement to jointly develop and commercialize the agent.

The randomized, open-label, multicenter trial was intended to explore the safety and efficacy of ficlatuzumab with high-dose cytarabine versus cytarabine alone in 60 patients with relapsed/refractory AML. Ficlatuzumab would have been at 20 mg/kg intravenously on days 1 and 15 plus intravenous cytarabine 2 g/m² per day on days 2 through 7. If patients experienced prolonged myelosuppression, they were able to receive an extra 1 or 2 doses on days 29 and 43. In the control arm, cytarabine was administered at 2 g/m² per day on days 1 through 6.

Enrollment was limited to patients who had relapsed or were refractory to their induction therapy, which was to consist of no more than 2 cycles of cytotoxic chemotherapy with an anthracycline and cytarabine. Adequate organ function, ejection fraction ≥40%, and an ECOG performance status of 0 to 2 were also required. Patients with secondary AML due to progression of myelodysplastic syndrome or myeloproliferative neoplasms were to be allowed in the trial.

Overall response rate was the study’s primary end point with secondary measures of adverse events, overall survival, and disease-free survival.

The agent is still being investigated in a clinical trial of patients with squamous cell carcinoma of the head and neck.
Several other pharmaceutical companies, including Eli Lilly and Galapagos, have given notice of discontinued trials across medical specialties due to COVID-19, and many other trials have halted the enrollment of new patients.