HealthDay News — For patients with relapsed or refractory (RR) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the oral, dual inhibitor of phosphoinositide 3-kinase-δ and -γ, duvelisib, seems effective, according to a study published online October 4 in Blood.
Ian W. Flinn, MD, PhD, from the Sarah Cannon Research Institute in Nashville, Tennessee, and colleagues present the results of a global, Phase 3 randomized study of duvelisib vs. ofatumumab monotherapy for patients with RR CLL/SLL. Participants were randomly allocated to receive oral duvelisib 25 mg twice daily (160 patients) or ofatumumab intravenous (159 patients).
The researchers found that all patients met the primary end point, with significant improvement in progression-free survival per Independent Review Committee assessment compared with ofatumumab (median, 13.3 vs. 9.9 months; hazard ratio, 0.52), including those with high-risk chromosome 17p13.1 deletions (del[17p]) and/or TP53 mutations (hazard ratio, 0.4). Regardless of del(17p) status, the overall response rate was significantly higher with duvelisib (74 vs. 45%). Diarrhea, neutropenia, pyrexia, nausea, anemia, and cough were the most common adverse events in the duvelisib arm, while neutropenia and infusion reactions were the most common in the ofatumumab arm.
“The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Verastem Oncology and Infinity Pharmaceuticals, which manufacture and license duvelisib and funded the study.