IPI-145: Additional Phase I data

Data from 47 evaluable patients with relapsed or refractory chronic lymphocytic leukemia (CLL) in an open-label, U.S. Phase I trial showed that twice-daily oral IPI-145 led to an overall response rate (ORR) of 47% according to International Workshop on CLL (IWCLL) response criteria, including 1 complete response and 21 partial responses plus 24 cases of stable disease. In 19 evaluable CLL patients with deletion of chromosome 17 (del17p), IPI-145 led to 8 partial responses and 10 cases of stable disease. Median time to response was <2 months. Additionally, data from 26 evaluable patients with T cell lymphomas showed that IPI-145 led to an ORR of 38%, including 1 complete response and 9 partial responses plus 7 cases of stable disease. Furthermore, in 15 patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), IPI-145 given at twice-daily doses of <=25 mg led to an ORR of 73%, including 3 complete responses, 7 partial responses and 1 minor response. Data were presented at the American Society of Hematology meeting in New Orleans.

Infinity previously reported data from the trial in December 2012 and June 2013 (see BioCentury, Dec. 17, 2012 & June 10, 2013). In December, Infinity started the Phase III DUO trial with IPI-145 in patients with relapsed or refractory CLL or small cell lymphocytic lymphoma (SLL).The compound has Orphan Drug designation in the U.S. and EU to treat CLL/SLL and in the U.S. to treat follicular lymphoma. ...