1. A Phase 1b Study of Lenvatinib plus Pembrolizumab in Patients with Unresectable Hepatocellular Carcinoma: Extended Analysis of Study 116.
- Author
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Kudo, Masatoshi, Finn, Richard S., Ikeda, Masafumi, Sung, Max W., Baron, Ari D., Okusaka, Takuji, Kobayashi, Masahiro, Kumada, Hiromitsu, Kaneko, Shuichi, Pracht, Marc, Meyer, Tim, Nagao, Satoshi, Saito, Kenichi, Mody, Kalgi, Ramji, Zahra, Dubrovsky, Leonid, and Llovet, Josep M.
- Subjects
PROGRESSION-free survival ,OVERALL survival ,HEPATOCELLULAR carcinoma ,PATIENT safety ,ANTINEOPLASTIC agents - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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