Trovagene Inc. said its blood cancer drug in combination with chemotherapy showed an increase in response to treatment for certain patients in an early-stage trial.
San Diego-based Trovagene evaluated its drug onvansertib in combination with Otsuka Pharmaceutical Co. Ltd.'s Dacogen, or decitabine, for the treatment of patients with relapsed and difficult to treat acute myeloid leukemia in a phase 1b trial.
AML is a rare type of blood cancer that develops in the bone marrow and without treatment can become life-threatening quickly.
The study of 21 patients with relapsed AML achieved its main efficacy goal, showing no detectable cancer, known as complete response, and complete response with incomplete blood recovery in five of the patients. Additionally, 30% of the patients were biomarker positive, which was linked with a greater response to treatment measured by decreases in bone marrow blasts and the rate of complete response. Results from the trial found the treatment to be safe and well-tolerated.
The company also announced the start of a phase 2 trial of the treatment, saying it plans to enroll 32 patients with relapsed AML who have received up to one prior therapy.
