Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: Results from the phase 3 VOLGA trial
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 3194 条
VOLGA
★★★晚破52 人 · 73 条 · 2 篇摘要
本事件热度走势
当前热度 30·可比范围峰值 36(10月25日 02:00)·近 24 小时可比范围变化 –·当前参与者 47
先厘清一个检索层面的巧合:背景文献库中与“VOLGA”对应的条目,全部属于遗传学领域的“伏尔加德国家系”研究,即染色体1q31-42上与早发性家族性阿尔茨海默病连锁的位点[3]、该家系中STM2(即PSEN2)基因的N141I错义突变[1],以及同处伏尔加河中游地区的楚瓦什红细胞增多症VHL Arg200Trp突变[5]。这些文献与本次ESMO26报告的VOLGA膀胱癌试验仅共享地名,并无科学关联,因此不作为同类证据引用。真正构成这一领域既有认识、且在现场被反复提及的,是NIAGARA(围手术期durvalumab联合化疗)取得阳性结果,以及EV联合pembrolizumab的围手术期方案已被PGrivas等专家称为MIBC的现有标准治疗(SOC)。
本次会议上,VOLGA以LBA2列入总统研讨会报告,且是会前医生发帖讨论热度最高的试验之一。人群为顺铂不合适或拒绝顺铂的MIBC患者;据现场帖,方案为新辅助EV联合围手术期durvalumab(Tawagi的帖中写作durva/treme/EV,具体构成待确认),结果显著改善EFS与OS:EFS的HR为0.55,24个月率78%对69%;OS的HR为0.58,24个月率83%对75%;pCR为45%对10%。值得注意的是,该试验中EV仅用于新辅助阶段、术后不再给辅助EV,与EV同时覆盖辅助阶段的KEYNOTE-905/EV-303不同。同一专场还报告了KEYNOTE-866(吉西他滨/顺铂联合pembro或安慰剂):未达主要终点,pCR为44.4%对35.8%,但EFS与OS均无统计学显著,与阳性的NIAGARA形成对照。另有帖提到VOLGA目前已处于优先审评状态。
相对已有认识,VOLGA推进的一步在于回答了DCockrell提出的降强度问题:在EV+IO已明确改善MIBC结局的背景下,能否省去术后EV、构建毒性更低的围手术期模式?在顺铂不合适这一化疗受限人群中,新辅助EV加围手术期durvalumab同时拿到EFS和OS获益,且pCR差距悬殊(45%对10%),提示缩短EV疗程或可保留疗效;与同场失败的KEYNOTE-866并置来看,PD-1加化疗路径的失利也反衬出ADC联合IO的差异化价值。局限在于:上述数字均来自现场帖转述,手术结局、毒性与亚组细节未披露,会场讨论及全文数据有待确认;此外帖子间对方案组分(是否含tremelimumab)表述不一,需以正式发表为准。
- 1.Candidate gene for the chromosome 1 familial Alzheimer's disease locus · Science 1995
- 2.Genetic linkage evidence for a familial Alzheimer's disease locus on chromosome 14 · Science 1992
- 3.A familial Alzheimer's disease locus on chromosome 1 · Science 1995
- 4.Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis · Neurology 2014
- 5.Disruption of oxygen homeostasis underlies congenital Chuvash polycythemia · Nat Genet 2002
- 6.The presenilin 2 mutation (N141I) linked to familial Alzheimer disease (Volga German families) increases the secretion of amyloid beta protein ending at the 42nd (or 43rd) residue · Proc Natl Acad Sci U S A 1997
VOLGA
https://esmocongress.esmo.orgDavid H Aggen, MD PhD@Dr_Aggen Volga 的 EFS 和 OS 数据:Durva/EV 与 Durva/Treme #ESMO26 #oncoalert
Shankar Siva@_ShankarSiva JNCI@JNCI_Now 想在 #ESMO26 主席论坛演讲后了解解读 VOLGA 的背景信息吗? 请查看这 2 篇关于 pCR 和围手术期治疗的 JNCI 文章 👇 @myESMO #BladderCancer
Álvaro Pinto@dralvaropinto OncLive.com@OncLive DCockrellMD@DCockrellMD Julian Chavarriaga@chavarriagaj Mario Balsa@MarioBalsaMD 引用@An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session Presented by our @OncoALert 🚨faculty @tompowles1 Perioperative Durvalumab ± Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial @jteoh_hk @CPRT65 🔬 Phase 3 VOLGA trial (n=695) Evaluated perioperative durvalumab (D) ± tremelimumab (T) plus neoadjuvant enfortumab vedotin (EV) versus control (radical cystectomy [RC], followed by observation or approved adjuvant therapy) in cisplatin-ineligible muscle-invasive bladder cancer (MIBC). Just PUBLISHED in @NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2608323?referrer=https%3A%2F%2Ft.co%2F Interim analysis; median event-free survival (EFS) follow-up: 22.9 months. ➡️ D + EV: EFS HR 0.51 (95% CI, 0.38–0.67); OS HR 0.58 (95% CI, 0.40–0.83) ➡️ D + T + EV: EFS HR 0.61 (95% CI, 0.47–0.80); OS did not meet statistical significance ➡️ Pathological complete response (pCR): 45% with D + EV vs 10% with control ➡️ Grade 3/4 treatment-related adverse events (TRAEs): 30% with D + EV vs 42% with control ✅ Both primary EFS endpoints were met. Perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS. 🎙️ Presenter: Thomas Powles 👥 Investigators: Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto @DrChoueiri @tompowles1 @apolo_andrea @neerajaiims @montypal @Silke_Gillessen @AOmlin @brian_rini @PGrivasMDPhD @TiansterZhang @amerseburger @DrDanielHeng @HHammersMD @scocmem @AndreaNecchi @AmandaNizamMD @drenriquegrande @nataliagandur @AlbigesL @cdanicas @declangmurphy @seanmmcbride @shilpaonc @DrRanaMcKay @scserendipity1 @DrYukselUrun @ravikanesvaran @BraunMDPhD @EfstathiouEleni @mzugman @crisbergerot @niklas_kluemper @Markuseckstein3
Vilma P. Barcia MD, PhD, MSc@DrVilmaPBarcia 引用@An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session Presented by our @OncoALert 🚨faculty @tompowles1 Perioperative Durvalumab ± Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial @jteoh_hk @CPRT65 🔬 Phase 3 VOLGA trial (n=695) Evaluated perioperative durvalumab (D) ± tremelimumab (T) plus neoadjuvant enfortumab vedotin (EV) versus control (radical cystectomy [RC], followed by observation or approved adjuvant therapy) in cisplatin-ineligible muscle-invasive bladder cancer (MIBC). Just PUBLISHED in @NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2608323?referrer=https%3A%2F%2Ft.co%2F Interim analysis; median event-free survival (EFS) follow-up: 22.9 months. ➡️ D + EV: EFS HR 0.51 (95% CI, 0.38–0.67); OS HR 0.58 (95% CI, 0.40–0.83) ➡️ D + T + EV: EFS HR 0.61 (95% CI, 0.47–0.80); OS did not meet statistical significance ➡️ Pathological complete response (pCR): 45% with D + EV vs 10% with control ➡️ Grade 3/4 treatment-related adverse events (TRAEs): 30% with D + EV vs 42% with control ✅ Both primary EFS endpoints were met. Perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS. 🎙️ Presenter: Thomas Powles 👥 Investigators: Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto @DrChoueiri @tompowles1 @apolo_andrea @neerajaiims @montypal @Silke_Gillessen @AOmlin @brian_rini @PGrivasMDPhD @TiansterZhang @amerseburger @DrDanielHeng @HHammersMD @scocmem @AndreaNecchi @AmandaNizamMD @drenriquegrande @nataliagandur @AlbigesL @cdanicas @declangmurphy @seanmmcbride @shilpaonc @DrRanaMcKay @scserendipity1 @DrYukselUrun @ravikanesvaran @BraunMDPhD @EfstathiouEleni @mzugman @crisbergerot @niklas_kluemper @Markuseckstein3
Yakup Ergün@dr_yakupergun 引用@#ESMO26 | VOLGA | Presidential Symposium-1 In cisplatin-ineligible/refusing MIBC, neoadjuvant EV + perioperative durvalumab significantly improved EFS and OS vs the control arm. EFS: HR 0.55 (24-month: 78% vs 69%) OS: HR 0.58 (24-month: 83% vs 75%) pCR: 45% vs 10% Impressive results! Unlike KEYNOTE-905/EV-303, EV was administered only in the neoadjuvant setting, with no adjuvant EV. I’m looking forward to the discussion during the session.
Mustafa Özdoğan, MD@ozdogan_md OncLive.com@OncLive Shilpa Gupta@shilpaonc Shilpa Gupta@shilpaonc 引用@The #ESMO26 Presidential Symposium is about to begin! 🔥 Super excited to hear the highly anticipated results of the VOLGA trial, presented by the the only and only @tompowles1! @myESMO @apolo_andrea @Uromigos @brian_rini @OncoAlert @LosUromigos @uromigosjapan @MichvdHeijden
Dr Adam Januszewski@AdamJanuszewski International Urology Cancer Summit@urologysummit International Urology Cancer Summit@urologysummit Oncology Learning Network@OncLearnNetwork Julian Chavarriaga@chavarriagaj Abeid Athman (Omar).@bin_abeid Ahmed Alanazi | أحمد العنزي@alanazi002 ESMO - Eur. Oncology@myESMO Yakup Ergün@dr_yakupergun 引用@#ESMO26 | VOLGA | Presidential Symposium-1 In cisplatin-ineligible/refusing MIBC, neoadjuvant EV + perioperative durvalumab significantly improved EFS and OS vs the control arm. EFS: HR 0.55 (24-month: 78% vs 69%) OS: HR 0.58 (24-month: 83% vs 75%) pCR: 45% vs 10% Impressive results! Unlike KEYNOTE-905/EV-303, EV was administered only in the neoadjuvant setting, with no adjuvant EV. I’m looking forward to the discussion during the session.
yaelwaknine@yaelwaknine Beth Nally@BethN01 令人振奋的是,能出席#ESMO26的首场主席论坛,两项P3试验正以截然不同的方式拓展围手术期癌症治疗的边界。
Amanda Nizam, MD@AmandaNizamMD Dr. Bishoy M. Faltas@FaltasLab Congratulations @tompowles1 and team! EVD #VOLGA #ESMO26
引用@Presented at #ESMO26: In patients with muscle-invasive bladder cancer, event-free survival at 24 months was 63.5% with perioperative durvalumab plus neoadjuvant enfortumab vedotin as compared with 45.1% with surgery alone. Full phase 3 VOLGA trial results: https://nej.md/4z7dQFm @myESMO
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Elisabetta Bonzano MD, PhD@to_be_elizabeth 引用@An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session Presented by our @OncoALert 🚨faculty @tompowles1 Perioperative Durvalumab ± Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial @jteoh_hk @CPRT65 🔬 Phase 3 VOLGA trial (n=695) Evaluated perioperative durvalumab (D) ± tremelimumab (T) plus neoadjuvant enfortumab vedotin (EV) versus control (radical cystectomy [RC], followed by observation or approved adjuvant therapy) in cisplatin-ineligible muscle-invasive bladder cancer (MIBC). Just PUBLISHED in @NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2608323?referrer=https%3A%2F%2Ft.co%2F Interim analysis; median event-free survival (EFS) follow-up: 22.9 months. ➡️ D + EV: EFS HR 0.51 (95% CI, 0.38–0.67); OS HR 0.58 (95% CI, 0.40–0.83) ➡️ D + T + EV: EFS HR 0.61 (95% CI, 0.47–0.80); OS did not meet statistical significance ➡️ Pathological complete response (pCR): 45% with D + EV vs 10% with control ➡️ Grade 3/4 treatment-related adverse events (TRAEs): 30% with D + EV vs 42% with control ✅ Both primary EFS endpoints were met. Perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS. 🎙️ Presenter: Thomas Powles 👥 Investigators: Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto @DrChoueiri @tompowles1 @apolo_andrea @neerajaiims @montypal @Silke_Gillessen @AOmlin @brian_rini @PGrivasMDPhD @TiansterZhang @amerseburger @DrDanielHeng @HHammersMD @scocmem @AndreaNecchi @AmandaNizamMD @drenriquegrande @nataliagandur @AlbigesL @cdanicas @declangmurphy @seanmmcbride @shilpaonc @DrRanaMcKay @scserendipity1 @DrYukselUrun @ravikanesvaran @BraunMDPhD @EfstathiouEleni @mzugman @crisbergerot @niklas_kluemper @Markuseckstein3
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