Study ASTX727-01-B (ClinicalTrials.gov Identifier: NCT02103478)
The open-label, randomized, 2-cycle, 2-sequence crossover study included 80 adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). Patients were randomly assigned to receive Inqovi orally in cycle 1 and decitabine 20mg/m2 intravenously in cycle 2 or the reverse sequence. Both Inqovi and IV decitabine were administered once daily on days 1 through 5 of the 28-day cycle. Starting with cycle 3, all patients received Inqovi orally once daily on days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.
The median follow-up time was 24 months (range, 12-28.8 months) and the median duration of treatment was 6.6 months (range, <0.1-27.9). Results showed that 18% (95% CI, 10-28) of patients had a complete response (CR) with a median duration of CR of 8.7 months (95% CI, 1.1-18.2). The median time to CR was 4.8 months (95% CI, 1.7-10).
Among patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline (n=41), 49% became transfusion independent during any consecutive 56-day post baseline period. Among patients who were independent of transfusions at baseline (n=39), 64% remained transfusion-independent during any consecutive 56-day post baseline period.
Study ASTX727-02 (ClinicalTrials.gov Identifier: (NCT03306264)
The open-label, randomized, 2-cycle, 2-sequence crossover study that included 133 adult patients with MDS or CMML. Patients were randomly assigned to receive Inqovi orally in cycle 1 and decitabine 20mg/m2 intravenously in cycle 2 or the reverse sequence. Both Inqovi and IV decitabine were administered once daily on days 1 through 5 of the 28-day cycle. Starting with cycle 3, all patients received Inqovi orally once daily on days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.
The median follow-up time was 12.6 months (range, 9.3-20.5) and median duration of treatment was 8.2 months (range, 0.2-19.7). Results showed that 21% (95% CI, 15-29) of patients had a CR with a median duration of CR of 7.5 months (95% CI, 1.6-17.5). The median time to CR was 4.3 months (95% CI, 2.1-15.2).
Among patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline (n=57), 53% became transfusion independent during any consecutive 56-day post baseline period. Among patients who were independent of transfusions at baseline (n=76), 63% remained transfusion-independent during any consecutive 56-day post baseline period.