Gilead reports more data, regulatory update for idelalisib

Gilead Sciences Inc. (NASDAQ:GILD) presented additional data at the American Society of Hematology meeting showing twice-daily oral idelalisib led to a median overall survival (OS), a secondary endpoint, of 20.3 months in the Phase II Study 101-09 to treat refractory indolent non-Hodgkin's lymphoma (NHL). The company also presented updated data showing idelalisib led to an overall response rate (ORR) of 57% and a median progression-free survival (PFS) of 11 months. In June, Gilead reported interim data from the trial showing idelalisib led to an ORR of 53.6% and median PFS of 11.4 months. The single-arm, open-label, international trial enrolled 125 patients with previously treated indolent NHL that is refractory to both rituximab and to alkylating agent-containing chemotherapy. In September, Gilead submitted an NDA to FDA for the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta to treat refractory indolent NHL based on data from Study 101-09.

Gilead also provided a regulatory update on the compound, disclosing that last month EMA accepted for review an MAA for idelalisib to treat indolent NHL and chronic lymphocytic leukemia (CLL). The MAA is under accelerated assessment. Also, Gilead disclosed that FDA granted breakthrough therapy designation for idelalisib to treat relapsed CLL. In October, Gilead stopped early a Phase III trial evaluating idelalisib for CLL after a predefined interim analysis showed idelalisib plus rituximab met the primary endpoint of improving PFS vs. placebo plus rituximab (see BioCentury Extra, Oct. 9). ...