Liver cancer · 2026
Lenvatinib Added to Nivolumab and Ipilimumab Improves Tumor Control and Progression-Free Survival in Unresectable Hepatocellular Carcinoma.
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Zhang Ji-Zhe, Chen Jia-Lin, Fan Jia-Wen, Wang Jia-Qi, Yang Yuan-Hao, Xu Xin-Biao, Liu Bi-Heng, Chen Wei, Guo Guang-Can, Zou Chang-Ling
Аннотация
INTRODUCTION: In CheckMate-9DW, the suboptimal early tumor control of nivolumab-ipilimumab resulted in higher early mortality compared with the sorafenib/lenvatinib arm during the first 12 months. We evaluated whether adding lenvatinib to nivolumab-ipilimumab (NIL) improves outcomes versus nivolumab-ipilimumab (NI).
METHODS: Patients with unresectable HCC treated with NI with or without lenvatinib were retrospectively analyzed. Responses were evaluated by RECIST v1.1, survival outcomes by Kaplan-Meier and inverse probability of treatment weighting (IPTW) adjustment, and multiple sensitivity analyses. Liver function changes were evaluated using the albumin-bilirubin (ALBI) score.
RESULTS: Among 104 patients, 82 received NI and 22 received NIL. The NIL group demonstrated a higher disease control rate than the NI group (81.8% vs. 39.0%; p < 0.01), with similar duration of response (21.4 vs. 21.8 months). Median progression-free survival (PFS) was longer with NIL (10.2 vs. 3.2 months), but not for overall survival (OS). In the first-line setting, NIL showed a trend toward longer PFS and fewer early deaths within 12 months. After IPTW adjustment and sensitivity analyses, the NIL regimen consistently demonstrated improved PFS (HR 0.44; p < 0.01) without a statistically significant OS benefit. Hypertension, proteinuria and stomatitis were more frequent in the NIL group, while ALBI scores remained stable. Development of immune-related adverse events was associated with improved outcomes.
CONCLUSION: This real-world study provides proof-of-concept evidence that incorporating a VEGF inhibitor into dual ICIs therapy is associated with improved tumor control and prolonged PFS, with a potential reduction in early mortality. Prospective studies are warranted to confirm these findings.
METHODS: Patients with unresectable HCC treated with NI with or without lenvatinib were retrospectively analyzed. Responses were evaluated by RECIST v1.1, survival outcomes by Kaplan-Meier and inverse probability of treatment weighting (IPTW) adjustment, and multiple sensitivity analyses. Liver function changes were evaluated using the albumin-bilirubin (ALBI) score.
RESULTS: Among 104 patients, 82 received NI and 22 received NIL. The NIL group demonstrated a higher disease control rate than the NI group (81.8% vs. 39.0%; p < 0.01), with similar duration of response (21.4 vs. 21.8 months). Median progression-free survival (PFS) was longer with NIL (10.2 vs. 3.2 months), but not for overall survival (OS). In the first-line setting, NIL showed a trend toward longer PFS and fewer early deaths within 12 months. After IPTW adjustment and sensitivity analyses, the NIL regimen consistently demonstrated improved PFS (HR 0.44; p < 0.01) without a statistically significant OS benefit. Hypertension, proteinuria and stomatitis were more frequent in the NIL group, while ALBI scores remained stable. Development of immune-related adverse events was associated with improved outcomes.
CONCLUSION: This real-world study provides proof-of-concept evidence that incorporating a VEGF inhibitor into dual ICIs therapy is associated with improved tumor control and prolonged PFS, with a potential reduction in early mortality. Prospective studies are warranted to confirm these findings.