Positive Phase II data for GS 1101 in iNHL-Gilead

Gilead Sciences has announced results of a Phase II study (Study 101-09) evaluating GS 1101 (idelalisib) for the treatment of patients with indolent Non-Hodgkin�s Lymphoma (iNHL) that is refractory to rituximab and to alkylating-agent-containing chemotherapy. In this study, single-agent treatment with idelalisib achieved an overall response rate of 57% with a median duration of response of 12.5 months. Of the 71 patients who responded to therapy, 7 (6%) achieved a complete response, 63 (50%) had a partial response and one had a minor response. 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. The most common adverse event was diarrhea, which was reported in 16 patients.

In September 2013 Gilead submitted a New Drug Application to the FDA for GS 1101 for the treatment of refractory iNHL, and the drug was filed with the EMA for the same indication in November. The CHMP has accepted Gilead�s request for accelerated assessment for idelalisib and if approved, idelalisib could be available for marketing in the EU in the second half of 2014. The Phase II data were presented at the Annual Meeting of the American Society of Hematology.