SAFETY OF IDELALISIB IN B-CELL MALIGNANCIES: INTEGRATED ANALYSIS OF EIGHT CLINICAL TRIALS
Author(s): ,
Steven Coutre
Affiliations:
Stanford University School of Medicine,Stanford,United States
,
Jacqueline Barrientos
Affiliations:
Hofstra North Shore - LIJ School of Medicine,New Hyde Park,United States
,
Jennifer Brown
Affiliations:
Dana-Farber Cancer Institute,Boston,United States
,
Sven De Vos
Affiliations:
University of California Los Angeles,Los Angeles,United States
,
Richard Furman
Affiliations:
Weill Cornell Medical College,New York,United States
,
Michael Keating
Affiliations:
University of Texas MD Anderson Cancer Center,Houston,United States
,
Susan O'Brien
Affiliations:
Chao Family Comprehensive Cancer Center,Orange,United States
,
John Pagel
Affiliations:
Fred Hutchinson Cancer Research Center,Seattle,United States
,
Jeff Sharman
Affiliations:
US Oncology and Willamette Valley Cancer Institute,Springfield,United States
,
Andrew Zelenetz
Affiliations:
Memorial Sloan-Kettering Cancer Center,New York,United States
,
Terry Newcomb
Affiliations:
Gilead Sciences,Foster City,United States
,
Yoonjin Cho
Affiliations:
Gilead Sciences,Foster City,United States
,
Christopher Aguilar
Affiliations:
Gilead Sciences,Foster City,United States
Lyndah Dreiling
Affiliations:
Gilead Sciences,Foster City,United States
EHA Library. Coutre S. 06/13/15; 100729; S433
Dr. Steven E Coutre
Dr. Steven E Coutre
Contributions
Abstract
Abstract: S433

Type: Oral Presentation

Presentation during EHA20: From 13.06.2015 12:00 13.06.2015 12:15

Location: Room A7

Background
Idelalisib (Zydelig), a first-in-class, selective, oral inhibitor of PI3Kδ, is approved in the US and EU for the treatment of chronic lymphocytic leukemia (CLL) in combination with rituximab and as monotherapy for patients with follicular lymphoma who have received at least two prior systemic therapies.

Aims
To further characterize the safety profile of idelalisib, we integrated adverse event data from 8 clinical trials.

Methods
The analysis included 760 subjects with CLL, indolent non-Hodgkin lymphoma, or other B-cell malignancy who received IDELA alone (doses = 50 mg BID to 350 mg BID) or as part of a combination regimen (IDELA doses = 100 or 150 mg BID). Most subjects were heavily pre-treated with relapsed disease.

Results
Common adverse events (AEs) are presented in the table, along with important laboratory results. AEs leading to dose modification included transaminase elevations (13%), diarrhea/colitis (11%), and rash (5%); discontinuations due to these AEs were infrequent (3%, 5%, and 2%, respectively); dose interruption allowed successful re-challenge in most patients. Pneumonitis occurred in 2.3% (monotherapy) and 3.9% (combo therapy) of subjects. Grade ≥ 3 diarrhea/colitis had a later onset (peak incidence of 9% between 6-12 mo.); other AEs occurred most often in the first 6 months and declined thereafter.

Summary
As well-characterized in this large dataset, IDELA has an acceptable safety profile.

Keyword(s): Chronic lymphocytic leukemia, Clinical trial, Non-Hodgkin's lymphoma, PI3K



Session topic: Chronic lymphocytic leukemia - Clinical 2
Abstract: S433

Type: Oral Presentation

Presentation during EHA20: From 13.06.2015 12:00 13.06.2015 12:15

Location: Room A7

Background
Idelalisib (Zydelig), a first-in-class, selective, oral inhibitor of PI3Kδ, is approved in the US and EU for the treatment of chronic lymphocytic leukemia (CLL) in combination with rituximab and as monotherapy for patients with follicular lymphoma who have received at least two prior systemic therapies.

Aims
To further characterize the safety profile of idelalisib, we integrated adverse event data from 8 clinical trials.

Methods
The analysis included 760 subjects with CLL, indolent non-Hodgkin lymphoma, or other B-cell malignancy who received IDELA alone (doses = 50 mg BID to 350 mg BID) or as part of a combination regimen (IDELA doses = 100 or 150 mg BID). Most subjects were heavily pre-treated with relapsed disease.

Results
Common adverse events (AEs) are presented in the table, along with important laboratory results. AEs leading to dose modification included transaminase elevations (13%), diarrhea/colitis (11%), and rash (5%); discontinuations due to these AEs were infrequent (3%, 5%, and 2%, respectively); dose interruption allowed successful re-challenge in most patients. Pneumonitis occurred in 2.3% (monotherapy) and 3.9% (combo therapy) of subjects. Grade ≥ 3 diarrhea/colitis had a later onset (peak incidence of 9% between 6-12 mo.); other AEs occurred most often in the first 6 months and declined thereafter.

Summary
As well-characterized in this large dataset, IDELA has an acceptable safety profile.

Keyword(s): Chronic lymphocytic leukemia, Clinical trial, Non-Hodgkin's lymphoma, PI3K



Session topic: Chronic lymphocytic leukemia - Clinical 2

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