The most common grade 3 adverse events were diarrhea (22%) and liver enzyme elevations (17%), with grade 4 neutropenia occurring in 28%.
In 16 patients with baseline computed tomography assessments, 88% achieved a nodal response (≥ 50% reduction in measurable area of disease) and all had a PR per iwCLL.
Median progression-free and overall survival had not been reached, with a 92% PFS rate and 94% survival rate at 18 months, Dr. O’Brien said. One patient died during follow-up, about 5 months after the last duvelisib dose.
Based on the pharmacodynamic/pharmacokinetic profile and clinical activity, the 25-mg twice-daily dose has been selected for phase III evaluation, she said.
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