Positive Phase III Results Reported for Idelalisib in Leukemia Patients
Trial ends early because of positive risk-benefit ratio (October 9)
Following a recommendation by an independent data monitoring committee (DMC), a phase III study evaluating idelalisib (Gilead Sciences) in previously treated patients with chronic lymphocytic leukemia (CLL) who are not candidates for chemotherapy will be stopped early.
The DMC’s recommendation was based on a predefined interim analysis that showed statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab (Rituxan, Genentech) compared with those receiving rituximab alone.
Patients who were randomly assigned to receive idelalisib will continue receiving the drug, and patients in the control arm (placebo plus rituximab) will become eligible to receive open-label idelalisib therapy, in an extension study.
A new drug application (NDA) for idelalisib was submitted to the FDA for the treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL) on September 11, 2013.
Idelalisib is an investigational, selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta. PI3K delta signaling is critical for the activation, proliferation, survival, and trafficking of B lymphocytes and is hyperactive in many B-cell malignancies. Idelalisib is being developed both as a single agent and in combination with approved and investigational therapies.
Source: Gilead Sciences; October 9, 2013.