Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial.
Clin Transl Oncol
; 26(6): 1532-1538, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38102374
ABSTRACT
PURPOSE:
Post hoc analysis of the JAVELIN Bladder 100 trial of avelumab maintenance in locally advanced/metastatic urothelial carcinoma (la/mUC) to determine the interaction by programmed death ligand 1 (PD-L1) status for overall survival (OS), and additional analyses of survival per a different PD-L1 expression cutoff of ≥ 1% in tumor cells or immune cells (TC/IC).METHODS:
JAVELIN Bladder 100 data were used for the analysis of the interaction by PD-L1 status (per cutoff used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a different ≥ 1% TC/IC PD-L1 expression cutoff (Ventana SP263 assay).RESULTS:
No significant interaction between treatment and PD-L1 status was observed for OS. Clinically meaningful and robust survival data were observed in favor of avelumab using the different ≥ 1% TC/IC PD-L1 expression cutoff.CONCLUSIONS:
These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Urinary Bladder Neoplasms
/
Carcinoma, Transitional Cell
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Antibodies, Monoclonal, Humanized
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B7-H1 Antigen
Limits:
Aged
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Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Clin Transl Oncol
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: