You are here

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs