Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial.
Abstract
BACKGROUND:We assessed the efficacy and safety of avelumab, an anti-programmed death
ligand 1 (PD-L1) antibody, in patients with previously treated metastatic adrenocortical
carcinoma (mACC). METHODS:In this phase 1b expansion cohort, patients with mACC and
prior platinum-based therapy received avelumab at 10 mg/kg intravenously every 2 weeks.
Continuation of mitotane was permitted; however, mitotane levels during the study
were not recorded. Tumor response was assessed by Response Evaluation Criteria In
Solid Tumors v1.1. RESULTS:Fifty patients received avelumab and were followed for
a median of 16.5 months. Prior treatment included ≥2 lines in 74.0%; mitotane was
continued in 50.0%. The objective response rate (ORR) was 6.0% (95% CI, 1.3% to 16.5%;
partial response in 3 patients). Twenty-one patients (42.0%) had stable disease as
best response (disease control rate, 48.0%). Median progression-free survival was
2.6 months (95% CI, 1.4 to 4.0), median overall survival (OS) was 10.6 months (95%
CI, 7.4 to 15.0), and the 1-year OS rate was 43.4% (95% CI, 27.9% to 57.9%). In evaluable
patients with PD-L1+ (n = 12) or PD-L1- (n = 30) tumors (≥5% tumor cell cutoff), ORR
was 16.7% vs 3.3% (P = .192). Treatment-related adverse events (TRAEs) occurred in
82.0%; the most common were nausea (20.0%), fatigue (18.0%), hypothyroidism (14.0%),
and pyrexia (14.0%). Grade 3 TRAEs occurred in 16.0%; no grade 4 to 5 TRAEs occurred.
Twelve patients (24.0%) had an immune-related TRAE of any grade, which were grade
3 in 2 patients (4.0%): adrenal insufficiency (n = 1), and pneumonitis (n = 1). CONCLUSIONS:Avelumab
showed clinical activity and a manageable safety profile in patients with platinum-treated
mACC. TRIAL REGISTRATION:Clinicaltrials.gov NCT01772004 ; registered January 21, 2013.
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https://hdl.handle.net/10161/21092Published Version (Please cite this version)
10.1186/s40425-018-0424-9Publication Info
Le Tourneau, Christophe; Hoimes, Christopher; Zarwan, Corrine; Wong, Deborah J; Bauer,
Sebastian; Claus, Rainer; ... Gulley, James L (2018). Avelumab in patients with previously treated metastatic adrenocortical carcinoma:
phase 1b results from the JAVELIN solid tumor trial. Journal for immunotherapy of cancer, 6(1). pp. 111. 10.1186/s40425-018-0424-9. Retrieved from https://hdl.handle.net/10161/21092.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Christopher Hoimes
Instructor in the Department of Medicine

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