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Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN
Christophe Le Tourneau1,2,3, Christopher Hoimes4, Corrine Zarwan5
1Department of Medical Oncology, Institut Curie, 26, rue d'ulm, 75005, Paris & Saint-Cloud, France. christophe.letourneau@curie.fr.
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.
Insights
Avelumab demonstrated clinical activity in patients with metastatic adrenocortical carcinoma (mACC) previously treated with chemotherapy. The anti-PD-L1 antibody showed a manageable safety profile, offering a new treatment option for this rare cancer.
Area of Science:
- Oncology
- Immunotherapy
- Adrenocortical Carcinoma Research
Background:
- Metastatic adrenocortical carcinoma (mACC) has limited treatment options after progression on platinum-based chemotherapy.
- Avelumab, an anti-programmed death ligand 1 (PD-L1) antibody, targets immune checkpoint pathways.
- Assessing avelumab's efficacy and safety in previously treated mACC patients is crucial.
Purpose of the Study:
- To evaluate the clinical activity and safety of avelumab in patients with previously treated mACC.
- To determine the objective response rate (ORR) and disease control rate (DCR) with avelumab treatment.
- To analyze progression-free survival (PFS) and overall survival (OS) in this patient population.
Main Methods:
- A phase 1b expansion cohort study involving 50 patients with mACC who received prior platinum-based therapy.
- Avelumab administered at 10 mg/kg intravenously every two weeks.
- Tumor response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Main Results:
- Objective response rate (ORR) was 6.0% (95% CI, 1.3% to 16.5%), with a disease control rate (DCR) of 48.0%.
- Median progression-free survival (PFS) was 2.6 months, and median overall survival (OS) was 10.6 months.
- Treatment-related adverse events (TRAEs) were manageable, with 16.0% experiencing Grade 3 TRAEs; no Grade 4-5 TRAEs were reported.
Conclusions:
- Avelumab exhibits clinical activity in platinum-treated mACC patients.
- The safety profile of avelumab is manageable in this cohort.
- Avelumab represents a potential therapeutic option for patients with previously treated mACC.
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