At the American Society of Hematology (ASH) 2003, Lead author Richard Furman, MD, reported that "combination treatment with the PI3K-delta inhibitor idelalisib and rituximab (Rituxan) was associated with a >70% improvement in overall survival (OS) in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), according to phase III data from Study 116 presented at the 55th Annual Meeting of the American Society of Hematology.
The idelalisib combination also improved progression-free survival (PFS), the primary endpoint of the trial, by >80% compared with the comparator arm of rituximab plus placebo.
On average, patients had received three prior regimens and were considered ineligible for additional chemotherapy. Between 80% and 90% of the patients had a Cumulative Illness Rating Score >6; 40% to 45% had a 17p deletion or TP53 mutation; 80% to 85% had unmutated IGHV; and about 40% of the patients had a creatinine clearance of <60 mL/min.
The trial was halted and crossover was allowed following a positive risk-benefit review from an independent data monitoring committee at an interim analysis.
When the trial stopped, the median PFS in the placebo group was 5.5 months, whereas the median had yet to be reached in the idelalisib arm. The difference in PFS translated into an 85% reduction in the hazard for the idelalisib group versus the placebo group."
(Includes brief OncLive TV statement by Dr. Richard Furman on Avoiding Chemotherapy with Idelalisib)
Also see the Patient Power interview of Dr Peter Hillmen taken in August 2013 at the iwCLL in Collogne Germany on his ideas on the role of Idelalisib