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A phase 2 study of idelalisib plus rituximab in treatment-naïve older patients with chronic lymphocytic leukemia.

Abstract
Idelalisib is a first-in-class oral inhibitor of PI3Kδ that has shown substantial activity in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). To evaluate idelalisib as initial therapy, 64 treatment-naïve older patients with CLL or small lymphocytic leukemia (median age, 71 years; range, 65-90) were treated with rituximab 375 mg/m(2) weekly ×8 and idelalisib 150 mg twice daily continuously for 48 weeks. Patients completing 48 weeks without progression could continue to receive idelalisib on an extension study. The median time on treatment was 22.4 months (range, 0.8-45.8+). The overall response rate (ORR) was 97%, including 19% complete responses. The ORR was 100% in patients with del(17p)/TP53 mutations and 97% in those with unmutated IGHV. Progression-free survival was 83% at 36 months. The most frequent (>30%) adverse events (any grade) were diarrhea (including colitis) (64%), rash (58%), pyrexia (42%), nausea (38%), chills (36%), cough (33%), and fatigue (31%). Elevated alanine transaminase/aspartate transaminase was seen in 67% of patients (23% grade ≥3). The combination of idelalisib and rituximab was highly active, resulting in durable disease control in treatment-naïve older patients with CLL. These results support the further development of idelalisib as initial treatment of CLL. This study is registered at ClinicalTrials.gov as #NCT01203930.
AuthorsSusan M O'Brien, Nicole Lamanna, Thomas J Kipps, Ian Flinn, Andrew D Zelenetz, Jan A Burger, Michael Keating, Siddhartha Mitra, Leanne Holes, Albert S Yu, David M Johnson, Langdon L Miller, Yeonhee Kim, Roger D Dansey, Ronald L Dubowy, Steven E Coutre
JournalBlood (Blood) Vol. 126 Issue 25 Pg. 2686-94 (Dec 17 2015) ISSN: 1528-0020 [Electronic] United States
PMID26472751 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Copyright© 2015 by The American Society of Hematology.
Chemical References
  • Purines
  • Quinazolinones
  • Rituximab
  • idelalisib
Topics
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Disease-Free Survival
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy, mortality)
  • Male
  • Purines (administration & dosage, adverse effects)
  • Quinazolinones (administration & dosage, adverse effects)
  • Rituximab (administration & dosage, adverse effects)
  • Treatment Outcome

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