Gilead stops CLL trial early for efficacy
Gilead Sciences Inc. (NASDAQ:GILD) stopped early the Phase III Study 116 evaluating twice-daily oral idelalisib to treat relapsed chronic lymphocytic leukemia (CLL) after a predefined interim analysis showed idelalisib plus rituximab met the primary endpoint of improving progression-free survival (PFS) vs. placebo plus rituximab. The double-blind, international trial enrolled 220 patients with previously treated recurrent CLL who had measurable lymphadenopathy with disease progression less than 24 months after completing prior therapy and who were ineligible for cytotoxic therapy. Gilead said it plans to meet with FDA to discuss a regulatory application for idelalisib for CLL, but declined to disclose details.
Last month, Gilead submitted an NDA to FDA for idelalisib to treat refractory indolent non-Hodgkin's lymphoma (NHL), with an EU regulatory application planned for this quarter. The company gained the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta through its 2011 acquisition of Calistoga Pharmaceuticals Inc. ...