Gilead announced results from the Phase 2 study (Study 101-09) evaluating idelalisib, an investigational oral inhibitor of PI3K delta, for the treatment of patients with indolent non-Hodgkin’s lymphoma (iNHL) that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
Study 101-09 is an open-label, single-arm efficacy and safety study of idelalisib in patients with previously treated iNHL that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.
In this study, treatment with idelalisib achieved an overall response rate of 57% with a median duration of response of 12.5 months. Seven (6%) patients achieved a complete response, 63 (50%) patients had partial response, and one (1%) patient had a minor response. Among those who responded, the median time to response was 1.9 months. Median progression-free survival for all patients was 11.0 months and median overall survival was 20.3 months. Ninety percent of patients experienced shrinkage in lymph node size.
Previously, on September 11, 2013, Gilead submitted a New Drug Application (NDA) for idelalisib for the treatment of refractory iNHL. Idelalisib was subsequently granted Breakthrough Therapy designation for chronic lymphocytic leukemia (CLL) in relapsed patients.
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