Phase III DUO trial of Copiktra in CLL + SLL is published in Blood.- Verastem.

For some patients with difficult-to-treat leukemia and lymphoma, the investigational oral medicine Copiktra (duvelisib) from Verastem, may significantly improve disease outcomes, according to phase III trial data published in the journal Blood. The DUO trial studied the head-to-head comparison of duvelisib versus ofatumumab, an approved standard-of-care chemotherapy for relapsed or treatment-resistant chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). According to the study, duvelisib extended the progression-free survival from a median of 9.9 months on ofatumumab to 13.3 months.

Duvelisib's benefit also appeared to extend to patients with high-risk genetic mutations and poorer prognoses. In sub-group analyses, researchers found duvelisib worked just as well as ofatumumab among the hardest-to-treat cases, including those patients with p17 deletion or p53 abnormalities, who have few available therapeutic options. Patients with these genetic mutations who took duvelisib had a 60 percent reduction in their risk of cancer progression or death compared to similar patients in the ofatumumab group. Overall response rate was also higher in the duvelisib group (74 vs. 45 percent, respectively). Median duration of treatment was 50 weeks for the duvelisib group and 23 weeks for those receiving ofatumumab, allowing researchers to collect more data on side effects.

The most common adverse events were diarrhea, nausea, pyrexia, neutropenia, anemia, and cough in the duvelisib group and neutropenia and infusion reactions in the ofatumumab arm. Most people taking duvelisib (78 percent) also had meaningful reductions in their lymph nodes compared with 16 percent of patients receiving ofatumumab. Swollen lymph nodes in the neck, arms, and abdomen can lead to limited mobility and increased discomfort.

See: "The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL/SLL" Ian W. Flinn et al. Blood 2018 :blood-2018-05-850461; doi: https://doi.org/10.1182/blood-2018-05-850461