Idelalisib: Interim Phase II data

Interim data from the single-arm, open-label, international Phase II Study 101-09 in 125 patients with indolent NHL showed that twice-daily 150 mg oral idelalisib led to an ORR of 53.6%, including 5 complete responses, 60 partial responses and 2 minor responses, plus 46 cases of stable disease. Median PFS was 11.4 months, median duration of response was 11.9 months and median time to response was 1.9 months. In a subgroup of 45 patients who were refractory to both rituximab and bendamustine, idelalisib led to an ORR of 60%. The most common >=grade 3 adverse event was diarrhea. The trial enrolled patients with previously treated indolent NHL that is refractory to both rituximab and to alkylating agent-containing chemotherapy. Data were presented at the Malignant Lymphoma meeting in Lugano. ...