First-line Pembrolizumab Plus Lenvatinib for Advanced Non–clear-cell Renal Cell Carcinoma: Updated Results from the Phase 2 KEYNOTE-B61 Trial

IF 25.3 1区 医学 Q1 UROLOGY & NEPHROLOGY
Martin H. Voss, Howard Gurney, Vagif Atduev, Cristina Suarez, Miguel A. Climent, David Pook, Piotr Tomczak, Philippe Barthélémy, Jae Lyun Lee, Taron Nalbandian, Viktor Stus, Thomas Ferguson, Pawel Wiechno, Erhan Gokmen, Louis Lacombe, Craig Gedye, Jerry Cornell, Manish Sharma, Joseph E. Burgents, Laurence Albiges
{"title":"First-line Pembrolizumab Plus Lenvatinib for Advanced Non–clear-cell Renal Cell Carcinoma: Updated Results from the Phase 2 KEYNOTE-B61 Trial","authors":"Martin H. Voss, Howard Gurney, Vagif Atduev, Cristina Suarez, Miguel A. Climent, David Pook, Piotr Tomczak, Philippe Barthélémy, Jae Lyun Lee, Taron Nalbandian, Viktor Stus, Thomas Ferguson, Pawel Wiechno, Erhan Gokmen, Louis Lacombe, Craig Gedye, Jerry Cornell, Manish Sharma, Joseph E. Burgents, Laurence Albiges","doi":"10.1016/j.eururo.2025.05.019","DOIUrl":null,"url":null,"abstract":"<h3>Background and objective</h3>Initial results from the KEYNOTE-B61 trial demonstrated that pembrolizumab combined with lenvatinib has promising antitumor activity in previously untreated advanced non–clear-cell renal cell carcinoma (nccRCC). We report updated efficacy and safety results after nearly 2 yr of follow-up.<h3>Methods</h3>The single-arm, multicenter, phase 2 KEYNOTE-B61 trial enrolled patients aged ≥18 yr with previously untreated advanced nccRCC. All participants received pembrolizumab 400 mg intravenously every 6 wk (up to 18 cycles, approx. 2 yr) plus lenvatinib 20 mg orally once daily. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 as assessed on blinded independent central review. Duration of response (DOR) and safety were secondary endpoints.<h3>Key findings and limitations</h3>A total of 158 patients received at least one dose of study treatment. Median follow-up was 22.8 mo (range 16.6–27.6). The ORR was 51% (95% confidence interval 43–59); 13 patients (8.2%) had a confirmed complete response and 67 (42%) had a confirmed partial response. In the subgroup with a confirmed response, median DOR was 19.5 mo (range 1.5+ to 23.5+). ORR was generally consistent across subgroups, including histologic subtypes (34–67%) and the presence of sarcomatoid features (47%). Grade 3 or 4 treatment-related adverse events were reported for 92 patients (58%). No deaths due to treatment-related adverse events occurred.<h3>Conclusion and clinical implications</h3>After approximately 2 yr of follow-up, pembrolizumab plus lenvatinib showed durable antitumor activity in KEYNOTE-B61, with no new safety signals. These results support pembrolizumab + lenvatinib as a first-line treatment option for advanced nccRCC.","PeriodicalId":12223,"journal":{"name":"European urology","volume":"23 1","pages":""},"PeriodicalIF":25.3000,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eururo.2025.05.019","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background and objective

Initial results from the KEYNOTE-B61 trial demonstrated that pembrolizumab combined with lenvatinib has promising antitumor activity in previously untreated advanced non–clear-cell renal cell carcinoma (nccRCC). We report updated efficacy and safety results after nearly 2 yr of follow-up.

Methods

The single-arm, multicenter, phase 2 KEYNOTE-B61 trial enrolled patients aged ≥18 yr with previously untreated advanced nccRCC. All participants received pembrolizumab 400 mg intravenously every 6 wk (up to 18 cycles, approx. 2 yr) plus lenvatinib 20 mg orally once daily. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 as assessed on blinded independent central review. Duration of response (DOR) and safety were secondary endpoints.

Key findings and limitations

A total of 158 patients received at least one dose of study treatment. Median follow-up was 22.8 mo (range 16.6–27.6). The ORR was 51% (95% confidence interval 43–59); 13 patients (8.2%) had a confirmed complete response and 67 (42%) had a confirmed partial response. In the subgroup with a confirmed response, median DOR was 19.5 mo (range 1.5+ to 23.5+). ORR was generally consistent across subgroups, including histologic subtypes (34–67%) and the presence of sarcomatoid features (47%). Grade 3 or 4 treatment-related adverse events were reported for 92 patients (58%). No deaths due to treatment-related adverse events occurred.

Conclusion and clinical implications

After approximately 2 yr of follow-up, pembrolizumab plus lenvatinib showed durable antitumor activity in KEYNOTE-B61, with no new safety signals. These results support pembrolizumab + lenvatinib as a first-line treatment option for advanced nccRCC.
一线派姆单抗联合Lenvatinib治疗晚期非透明细胞肾细胞癌:来自KEYNOTE-B61期试验的最新结果
KEYNOTE-B61试验的初步结果表明,派姆单抗联合lenvatinib在未经治疗的晚期非透明细胞肾细胞癌(nccRCC)中具有良好的抗肿瘤活性。在近2 年的随访后,我们报告了最新的疗效和安全性结果。方法:单臂、多中心、2期KEYNOTE-B61试验入组年龄≥18 岁、既往未治疗的晚期nccRCC患者。所有参与者接受pembrolizumab 400 mg静脉注射,每6 周(最多18个周期,约1周)。2 yr)加lenvatinib 20 mg口服,每日一次。主要终点是通过盲法独立中心评价,根据实体肿瘤反应评价标准v1.1评估客观缓解率(ORR)。反应持续时间(DOR)和安全性是次要终点。主要发现和局限性共有158例患者接受了至少一剂研究治疗。中位随访时间为22.8 月(16.6-27.6)。ORR为51%(95%置信区间43-59);13例(8.2%)患者确认完全缓解,67例(42%)患者确认部分缓解。在确认缓解的亚组中,DOR中位数为19.5 mo(范围1.5+至23.5+)。ORR在各个亚组中基本一致,包括组织学亚型(34-67%)和存在肉瘤样特征(47%)。92例(58%)患者报告了3级或4级治疗相关不良事件。未发生治疗相关不良事件导致的死亡。结论和临床意义经过大约2 年的随访,派姆单抗联合lenvatinib在KEYNOTE-B61中显示出持久的抗肿瘤活性,没有新的安全性信号。这些结果支持pembrolizumab + lenvatinib作为晚期nccRCC的一线治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
European urology
European urology 医学-泌尿学与肾脏学
CiteScore
43.00
自引率
2.60%
发文量
1753
审稿时长
23 days
期刊介绍: European Urology is a peer-reviewed journal that publishes original articles and reviews on a broad spectrum of urological issues. Covering topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, the journal also highlights recent advances in techniques, instrumentation, surgery, and pediatric urology. This comprehensive approach provides readers with an in-depth guide to international developments in urology.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信