Onvansertib in Trovagene trial safe and well tolerated in difficult-to-treat relapsed or refractory AML patients

Trovagene said that additional data from its ongoing Phase 1b/2 study of onvansertib combined with standard-of-care chemotherapy in Acute Myeloid Leukemia (AML) showed response to treatment in patients in the dose-escalation phase of the trial who received onvansertib at 27mg/m2 and 40mg/m2.

The greatest anti-leukemic activity, to-date, has been observed in the onvansertib + decitabine arm, now with 3 of 6 (50%) evaluable patients treated at the two highest dose levels tested to-date (27mg/m2 and 40mg/m2) achieving a complete response (2CR and 1CRi), the company said Friday. The first patient in the onvansertib + LDAC arm has achieved a complete response at the highest dose level of 40mg/m2 of onvansertib.

Thomas Adams, Chief Executive Officer and Chairman of Trovagene said: “As we continue advancing our AML trial to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), we look forward to sharing additional readouts on the efficacy and safety of onvansertib and the potential opportunity to bring a much-needed new treatment option to relapsed or refractory AML patients.”

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