Trovagene Completes Dosing of Patients Treated with Onvansertib, Decitabine in AML Trial

Trovagene announced completion of the second dosing cohort of Onvansertib, its first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor, in combination with standard-of-care decitabine, in its Phase 1b/2 clinical trial in patients with Acute Myeloid Leukemia (AML).

All three patients in the cohort successfully completed treatment with Onvansertib at 18mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine and the combination was well tolerated. The Safety Review Committee (SRC) has recommended escalating to the next dose level of Onvansertib at 27mg/m2 (approximately a 50% increase) in combination with decitabine.

"While we are still early in the trial, we continue to be excited by what we are seeing so far from both a safety and efficacy standpoint," said Amer Zeidan, MBBS, MHS, assistant professor of Medicine at Yale School of Medicine, Hematology expert at Yale Cancer Center, and lead investigator on the trial. "We did not see any dose limiting toxicities and treatment has been well tolerated in the cohort of three patients who received Onvansertib at 18 mg/m2 in combination with decitabine. One of our patients is about to start his 6th cycle of combination therapy, with significant reductions in his blast counts, transfusion independence, and no significant side effects. This is a very gratifying response to see, especially in the incurable setting of relapsed AML post allogeneic stem cell transplantation, where the focus is on quality of life improvement in addition to prolonging survival."

In the Phase 1b segment of this trial, the Onvansertib dose level will be increased by 50% increments in combination with either low-dose cytarabine (LDAC) or decitabine in successive cohorts of three patients until a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) is achieved. The MTD or RP2D will be used in the Phase 2 segment of the trial to evaluate antitumor activity and to continue to assess the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy.

"We are pleased with the progress we are making to identify our maximum tolerated dose and recommended Phase 2 dose for the continuation segment of our AML trial, as well as for use in other trials that we may do in the future in hematologic (leukemias/lymphomas) cancers," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene.

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