默克 WELIREG 联合仑伐替尼获欧盟 CHMP 积极意见：晚期肾细胞癌进展或死亡风险降低26%
默克（Merck，在美国与加拿大以外称 MSD）11月13日宣布，欧洲药品管理局人用药品委员会（CHMP）已通过积极意见，建议批准 WELIREG（belzutifan）联合仑伐替尼（lenvatinib），用于经抗 PD-1/PD-L1 治疗后、患有晚期透明细胞肾细胞癌的成人患者。WELIREG 是口服缺氧诱导因子 2α（HIF-2α）抑制剂，仑伐替尼是卫材发现的多受体酪氨酸激酶抑制剂。该建议现送欧盟委员会审议在欧盟、冰岛、列支敦士登与挪威的上市许可，最终决定预计在未来两个月内作出；若获批，这一组合将成为欧盟首个且唯一获批的 HIF-2α 抑制剂联合多靶点 VEGFR 酪氨酸激酶抑制剂方案。
这一意见的依据是三期 LITESPARK-011 试验的最终分析。该试验共入组747名患者，对照药物为卡博替尼。结果显示，联合方案把疾病进展或死亡风险降低26%（风险比0.74，95%置信区间0.61至0.89，p=0.001），中位无进展生存期为14.6个月，对照组为10.6个月；客观缓解率为53.1%，对照组为40.2%；中位缓解持续时间为22.0个月，对照组为11.9个月。总生存期方面，联合组死亡风险降低15%（风险比0.85，95%置信区间0.70至1.03），未达到统计学显著。该试验结果已在欧洲肿瘤内科学会（ESMO）2026年大会上报告。
这一联合方案已于2026年9月获美国食品药品管理局（FDA）批准，用于同一类患者。默克研究实验室全球肿瘤临床开发副总裁 Christina Derleth 参与发布了这一消息。
背景方面，肾细胞癌约占肾癌的九成，透明细胞亚型约占肾细胞癌的七成。默克引用的数据显示，2024年全球肾癌新发约442,570例，死亡约144,871例。
Merck's WELIREG Plus Lenvatinib Wins Positive EU CHMP Opinion: 26% Lower Risk of Progression or Death in Advanced Renal Cell Carcinoma
Merck, known as MSD outside the United States and Canada, announced on November 13 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of WELIREG (belzutifan) in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following treatment with an anti-PD-1/PD-L1 therapy. WELIREG is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, and lenvatinib is the multiple receptor tyrosine kinase inhibitor discovered by Eisai. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected within the next two months. If approved, the combination would become the first and only approved combination of an HIF-2α inhibitor and a multi-targeted VEGFR tyrosine kinase inhibitor in the EU.
The opinion is based on the final analysis of the Phase 3 LITESPARK-011 trial, which enrolled 747 patients and compared the combination with cabozantinib. The combination reduced the risk of disease progression or death by 26% (hazard ratio 0.74, 95% CI 0.61-0.89, p=0.001), with median progression-free survival of 14.6 months versus 10.6 months. The objective response rate was 53.1% versus 40.2%, and median duration of response was 22.0 months versus 11.9 months. Overall survival showed a 15% reduction in the risk of death (hazard ratio 0.85, 95% CI 0.70-1.03), which did not reach statistical significance. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026.
The combination was approved by the U.S. Food and Drug Administration in September 2026 for the same patient population. Christina Derleth, vice president of global clinical development for oncology at Merck Research Laboratories, was among the executives presenting the announcement.
Renal cell carcinoma accounts for about nine in ten kidney cancers, and the clear cell subtype accounts for about seven in ten renal cell carcinomas. Merck cited an estimated 442,570 new kidney cancer cases and 144,871 deaths worldwide in 2024.
来源：默克
发布：GSM·美国（发布链接）
图片来源：图：透明细胞肾细胞癌组织病理切片（2级）。Mikael Häggström 摄，CC0，经 Wikimedia Commons。 / Photo: Histopathology of grade 2 clear cell renal cell carcinoma. Photo by Mikael Häggström, CC0, via Wikimedia Commons.
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