The Phase 2 CyFi-2 study assessing the safety and efficacy of ficlatuzumab (previously AV-299) combined with standard chemotherapy in patients with hard-to-treat acute myeloid leukemia (AML) has been discontinued due to the COVID-19 pandemic, AVEO Oncology and Biodesix have announced.
The decision was taken as efforts to combat the pandemic forced an urgent shift among clinical sites, compromising the study’s completion. The trial had not yet started to recruit participants.
“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,” Michael Bailey, president and CEO of Aveo Oncology, said in a press release.
Ficlatuzumab, jointly developed and marketed by Aveo and Biodesix, is an antibody that inhibits a factor known as hepatocyte growth factor (HGF). When bound to its receptor (c-Met), HGF promotes the proliferation, invasion, and spreading of cancer cells in AML. By targeting the HGF ligand, ficlatuzumab prevents HGF/c-Met interactions and, consequently, may result in the death of these tumor cells.
The CyFi-2 study (NCT04100330) was a randomized, open-label, multicenter study designed to test the safety and efficacy of ficlatuzumab in combination with high-dose cytarabine (HiDAC), a standard chemotherapy regimen for AML, versus HiDAC alone in adult patients (18 or older) with relapsed or refractory AML (relapsing means the cancer returned after a successful treatment, and refractory means that the cancer has not responded to any prior treatments).
The study’s primary goal was to assess the overall response rate (the proportion of patients who have a partial or complete response to therapy) within 13 months of treatment completion in patients treated with ficlatuzumab in combination with HiDAC versus those given HiDAC alone.
Secondary goals included the number of participants with treatment-related adverse events, overall survival, and disease-free survival.
“Our investigators have been informed of the closure, and we greatly appreciate their enthusiasm for the study,” Bailey said. “We remain committed to the practice of scientific discovery and will focus our resources and efforts on our ongoing initiatives.”
Ficlatuzumab is currently being tested in a Phase 2 trial (NCT03422536) in patients with squamous cell carcinoma of the head and neck and in a Phase 1 trial (NCT03316599) in patients with advanced pancreatic cancer.
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