Gilead reports Phase II data for idelalisib
Gilead Sciences Inc. (NASDAQ:GILD) said twice-daily oral idelalisib plus rituximab led to an overall response rate (ORR) of 97% in the 64-patient Phase II Study 101-08 to treat previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). There were 12 complete responses and an estimated 24-month progression-free survival (PFS) rate of 93%. In the nine patients with deletion of chromosome 17 (del17p) or mutation in the tumor protein p53 ( TP53; p53) gene, idelalisib plus rituximab produced three complete responses. Data are to be presented at the American Society of Clinical Oncology meeting in June.
Based on the data, Gilead said it is evaluating Phase III trial designs for idelalisib as part of a first-line treatment regimen for CLL. The small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta is in three Phase III trials for previously treated CLL and a pair of Phase III trials for previously treated indolent non-Hodgkin's lymphoma (NHL). Gilead gained idelalisib through its 2011 acquisition of Calistoga Pharmaceuticals Inc. ...