Trovagene AML drug generates positive interim Phase 1b/2 data
Trovagene (NASDAQ:TROV) announced positive interim data from its Phase 1b/2 dose escalation trial of onvansertib, in combination with standard-of-care chemotherapy, in acute myeloid leukemia (AML) patients.
Three of six evaluable patients achieved a complete response at the highest doses of onvansertib (27mg/m2 and 40 mg/m2) in combination with decitabine.
"We are pleased with the response to treatment that we are seeing with onvansertib, as well as how safe and well tolerated it appears to be in this difficult-to-treat relapsed or refractory patient population," Thomas Adams, Trovagene’s chairman and CEO, said in a statement.
The objective of the ongoing Phase 1b/2 trial is to evaluate the safety and efficacy of onvansertib/chemotherapy combinations and to determine a maximum tolerated dose. The trial is currently enrolling patients at the 60mg/m2 dose level in combination with either decitabine or low-dose cytarabine.