Positive Ph II results for Gilead's idelalisib in refractory indolent non-Hodgkin's lymphoma

US biotech firm Gilead Sciences (Nasdaq: GILD) today (June 17) announced encouraging interim results from a single-arm, open-label Phase II study (Study 101-09) evaluating idelalisib (formerly GS-1101), an investigational, targeted, 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.

Previously, this has been a largely unstudied population for which there is significant unmet medical need for effective therapy. In the study, single-agent treatment with idelalisib achieved an overall response rate of 53.6%, with a median duration of response at this interim analysis of 11.9 months. Detailed study results will be presented on June 20 during an oral session at the 12th International Conference on Malignant Lymphoma in Lugano, Switzerland.

"Despite the progress achieved in recent years, most patients suffering from indolent non-Hodgkin's lymphoma will progressively become resistant to currently available treatments. Therefore, there is a significant unmet medical need for novel therapies," said Gilles Salles, Professor of Medicine, Department of Hematology, Claude Bernard University, Lyon-Sud Hospital Center, Pierre-Benite, France, noting: "These data suggest that idelalisib has the potential to provide durable disease control to this group of patients who have few if any remaining conventional treatment options."