A Phase 1b Study of Lenvatinib plus Pembrolizumab in Patients with Unresectable Hepatocellular Carcinoma: Extended Analysis of Study 116.
Liver Cancer
; 13(4): 451-458, 2024 Aug.
Article
em En
| MEDLINE
| ID: mdl-39114764
ABSTRACT
Introduction:
Lenvatinib (dosing for patients who weigh ≥60 kg was 12 mg/day; for patients who weigh <60 kg, the dose was 8 mg/day) plus pembrolizumab 200 mg once every 3 weeks demonstrated antitumor activity and a manageable safety profile in patients with first-line unresectable hepatocellular carcinoma (uHCC) in the open-label phase 1b Study 116/KEYNOTE-524 (primary analysis data cutoff date October 31, 2019; median follow-up 10.6 months). This analysis (updated data cutoff date March 31, 2021) reports efficacy results from 17 months of additional follow-up time.Methods:
100 patients with uHCC were included in the primary analysis (median follow-up 27.6 months). Endpoints included overall survival (OS), investigator-assessed progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) per modified RECIST. Landmark analyses of OS by the best response at 3 and 9 months were performed. Pembrolizumab antidrug antibodies (ADAs) and concentrations were also measured (cutoff date August 7, 2020).Results:
ORR was 43.0% (95% CI 33.1-53.3%) and median DOR was 17.1 months (95% CI 6.9-19.3 months). Median PFS and OS were 9.3 months (95% CI 7.4-9.8 months) and 20.4 months (95% CI 14.4-25.9 months), respectively. No treatment-emergent ADAs were detected.Conclusion:
Results show a sustained treatment effect with lenvatinib plus pembrolizumab in patients with uHCC in the first-line setting.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Liver Cancer
Ano de publicação:
2024
Tipo de documento:
Article