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First-Line Lenvatinib plus Pembrolizumab for Hepatocellular Carcinoma: Post hoc Analysis of Japanese Patients from the Phase 3 LEAP-002 Trial.

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Liver cancer 📖 저널 OA 100% 2025: 58/58 OA 2026: 24/24 OA 2025~2026 2025 Vol.14(4) p. 365-377
Retraction 확인
출처
PubMed DOI PMC

PICO 자동 추출 (휴리스틱, conf 2/4)

유사 논문
P · Population 대상 환자/모집단
80 patients were enrolled in Japan (lenvatinib plus pembrolizumab, = 39; lenvatinib plus placebo, = 41).
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Grade 3 or 4 treatment-related adverse events occurred in 26 patients (67%) in the lenvatinib plus pembrolizumab group and 24 patients (59%) in the lenvatinib plus placebo group. [CONCLUSION] In Japanese patients enrolled in LEAP-002, findings were consistent with the global population where OS and PFS trended toward improvement; a similar safety profile was observed.

Kudo M, Ikeda M, Aikata H, Numata K, Marusawa H, Hosaka T

📖 무료 전문 🟢 PMC 전문 PMC12360741
PubMed ↗ DOI ↗ BibTeX ↓ RIS ↓
📝 환자 설명용 한 줄

[INTRODUCTION] The phase 3 LEAP-002 study (NCT03713593) of advanced hepatocellular carcinoma (HCC) suggested improved antitumor activity of lenvatinib plus pembrolizumab versus lenvatinib alone with m

🔬 핵심 임상 통계 (초록에서 자동 추출 — 원문 검증 권장)
  • 95% CI 14.4-25.4
  • HR 0.54

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↓ .bib ↓ .ris
APA Kudo M, Ikeda M, et al. (2025). First-Line Lenvatinib plus Pembrolizumab for Hepatocellular Carcinoma: Post hoc Analysis of Japanese Patients from the Phase 3 LEAP-002 Trial.. Liver cancer, 14(4), 365-377. https://doi.org/10.1159/000542572
MLA Kudo M, et al.. "First-Line Lenvatinib plus Pembrolizumab for Hepatocellular Carcinoma: Post hoc Analysis of Japanese Patients from the Phase 3 LEAP-002 Trial.." Liver cancer, vol. 14, no. 4, 2025, pp. 365-377.
PMID 40831891 ↗
DOI 10.1159/000542572

Abstract

[INTRODUCTION] The phase 3 LEAP-002 study (NCT03713593) of advanced hepatocellular carcinoma (HCC) suggested improved antitumor activity of lenvatinib plus pembrolizumab versus lenvatinib alone with manageable safety, although overall survival (OS) and progression-free survival (PFS) did not reach prespecified statistical significance. This post hoc analysis assessed efficacy and safety in Japanese patients.

[METHODS] Patients with advanced HCC without prior systemic treatment were randomly assigned 1:1 to receive 8 mg (body weight <60 kg) or 12 mg (body weight ≥60 kg) oral lenvatinib once daily plus 200 mg intravenous pembrolizumab or placebo every 3 weeks for up to 35 cycles. Dual primary end points were OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary end points were objective response rate, disease control rate, duration of response, and time to progression per RECIST v1.1 by BICR and safety.

[RESULTS] Overall, 80 patients were enrolled in Japan (lenvatinib plus pembrolizumab, = 39; lenvatinib plus placebo, = 41). Median time from randomization to database cutoff (June 21, 2022) was 34.1 months (range: 26.9-39.6). Median OS was 31.4 months (95% CI: 21.2- not reached) for lenvatinib plus pembrolizumab and 21.4 months (95% CI: 14.4-25.4) for lenvatinib plus placebo (hazard ratio [HR] = 0.55 [95% CI: 0.31-0.96]). Median PFS for lenvatinib plus pembrolizumab was 10.4 months (95% CI: 6.2-18.5) and 6.5 months (95% CI: 6.0-8.3) for lenvatinib plus placebo (HR = 0.54 [95% CI: 0.32-0.90]). Grade 3 or 4 treatment-related adverse events occurred in 26 patients (67%) in the lenvatinib plus pembrolizumab group and 24 patients (59%) in the lenvatinib plus placebo group.

[CONCLUSION] In Japanese patients enrolled in LEAP-002, findings were consistent with the global population where OS and PFS trended toward improvement; a similar safety profile was observed.

🏷️ 키워드 / MeSH 📖 같은 키워드 OA만

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🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반

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