Journal
BLOOD
Volume 123, Issue 22, Pages 3398-3405Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2013-11-537555
Keywords
-
Categories
Funding
- Gilead Sciences, Inc. (Foster City, CA)
- Gilead Sciences, Inc. (Seattle, WA)
- Calistoga Pharmaceuticals, Inc. of Seattle, WA
Ask authors/readers for more resources
Idelalisib, an oral inhibitor of phosphatidylinositol-3-kinase delta (PI3K delta), was evaluated in a 48-week phase 1 study (50-350 mg daily or twice daily) enrolling 40 patients with relapsed or refractory mantle cell lymphoma (MCL). Primary outcome was safety and dose-limiting toxicity (DLT). Secondary outcomes were pharmacokinetic parameters, pharmacodynamic effects, overall response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Patients without DLT and no evidence of disease progression after 48 weeks enrolled in the extension study. Patients had median age of 69 years (range, 52-83) and receivedmedian of 4 prior therapies (1-14); 17 of 40 patients (43%) were refractory to their most recent treatment. Median duration of idelalisib treatment was 3.5 months (range, 0.7-30.7), with 6 (15%) continuing extension treatment. Commongrade >= 3 adverse events (AEs) included (total%/grade >= 3%) diarrhea (40/18), nausea (33/5), pyrexia (28/0), fatigue (25/3), rash (23/3), decreased appetite (20/15), upper respiratory infection (20/0), pneumonia (13/10), and alanine transaminase or aspartate transaminase elevations (60/20). ORR was 16 of 40 patients (40%), with CR in 2 of 40 patients (5%). Median DOR was 2.7 months, median PFS was 3.7 months, and 1-year PFS was 22%. These data provide proof of concept that targeting PI3K delta is a viable strategy and worthy of additional study in MCL. This trial was registered at www.clinicaltrials.gov as #NCT00710528.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available