Preliminary efficacy data from Trovagene’s Phase 1b/2 study testing onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia (AML) is encouraging, in particular that it shows some complete and relatively durable responses, said lead investigator of the trial, Dr. Amer Zeidan.
In an aupdate of the Trovagene’s trial, Zeidan said that AML patients with relapsed or refractory disease have short survival time and very limited treatment options, and the Phase 1b trial encourages by how safe and well-tolerated onvansertib appears to be thus far in this patient population.
He also noted that the evidence of clinical activity shown especially with the decitabine-based combination at the higher doses of onvansertib reaffirms the optimism.
“For example, one of my patients, who responded to treatment, is nearly one year out from the time of enrollment in this trial and continues to do quite well. We hope, as we continue in the trial and reach the recommended Phase 2 dose, that we will see additional evidence of clinical efficacy,” he said.