Format

Send to

Choose Destination
J Clin Oncol. 2019 Apr 17:JCO1801460. doi: 10.1200/JCO.18.01460. [Epub ahead of print]

Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.

Author information

1
1 Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR.
2
2 Stanford School of Medicine, Stanford, CA.
3
3 Weill Cornell Medical College, New York, NY.
4
4 Georgetown University Hospital, Washington DC.
5
5 Swedish Cancer Institute, Seattle, WA.
6
6 St James's University Hospital, Leeds, United Kingdom.
7
7 Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY.
8
8 Memorial Sloan Kettering Cancer Center, New York, NY.
9
9 University of California, San Diego, Moores Cancer Center, La Jolla, CA.
10
10 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
11
11 Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.
12
12 David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.
13
13 Venice Regional Bayfront Health, Venice, FL.
14
14 Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.
15
15 Centre Hospitalier Lyon-Sud, Pierre Benite, France.
16
† Deceased.
17
16 University of Liverpool, Liverpool, United Kingdom.
18
17 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.
19
18 Ulm University, Ulm, Germany.
20
19 University Hospital of Cologne, Cologne, Germany.
21
20 Gilead Sciences, Foster City, CA.
22
21 University of California, Irvine, Orange, CA.

Abstract

PURPOSE:

A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.

PATIENTS AND METHODS:

Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.

RESULTS:

The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases.

CONCLUSION:

IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.

PMID:
30995176
DOI:
10.1200/JCO.18.01460

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center