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 3137 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.orgOncoAlert@OncoAlert Tom Powles@tompowles1 Toni Choueiri, MD@DrChoueiri Karine Tawagi MD@DrKarineTawagi OncoAlert@OncoAlert Tom Powles@tompowles1 Oncology Brothers@OncBrothers 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
Yüksel Ürün@DrYukselUrun Karine Tawagi MD@DrKarineTawagi Tian Zhang, MD, MHS, FASCO (@tiansterzhangmd.bsky)@TiansterZhang NEJM@NEJM Petros Grivas@PGrivasMDPhD 引用@Full house for Bladder/RCC updates first with #KN866 #ESMO26 Gem/cis in MIBC + placebo or pembro (➖) study & less relevance in the era of EVP SOC Vs similar trial NIAGARA was ➕ pCR 44.4% vs 35.8% EFS & OS not significant We wait #VOLGA tomorrow for more in this space
Katy Beckermann@katy_beckermann Dr Amol Akhade@SuyogCancer 这些是 THE 曲线。Volga。新的 SOC。@tompowles1 @myESMO #ESMO26 @OncoAlert @OncBrothers。术前使用 3 剂 EV 就足够了。
Yakup Ergün@dr_yakupergun Dra. María Natalia Gandur Quiroga@nataliagandur 引用@🚨 #ESMO26 GU Oncology — Top picks by OncoAlert 🎯 #BladderCancer : VOLGA, KEYNOTE-B15, ENERGIZE, KEYNOTE-866 #ProstateCancer: DASL-HiCaP, CAPItello-281, PROTEUS #KidneyCancer: LITESPARK-011 & -012, ivonescimab, PE-PE, SWOG S2200, XmAb819 Our Participating Faculty @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, @ElisaAgostinett, @to_be_elizabeth, @MarioBalsaMD, @BRicciutiMD, @HHorinouchi, @UOzkerim, @p_ciracimd, @DrMirallas , @sonpavde , @Dr_Oncologista
David H Aggen, MD PhD@Dr_Aggen Sara Coca Membribes@scocmem 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
OncoAlert@OncoAlert Oriol Mirallas MD@DrMirallas Oncology Brothers@OncBrothers 引用@ESMO 2026 - presidential LBA | VOLGA Phase III – Perioperative Durvalumab + Enfortumab Vedotin (EV) in cisplatin-ineligible/refusing patients: 📊 EV + Durva vs Control • 2-year EFS: 64% vs 45% (HR 0.51; p<0.0001) • 2-year OS: 78% vs 69% (HR 0.58; p=0.0027) • pCR: 45% vs 10% Adding tremelimumab improved EFS (HR 0.61) but no significant OS benefit yet, with higher grade 3/4 toxicity (42% vs 30%). 🔥can this stop the need of post op EV ? Probably yes . New SOC 🙂👍 Looking forward the full datasets @OncBrothers @OncoAlert @myESMO #ESMO26 #VOLGA #BladderCancer
Shilpa Gupta@shilpaonc Karine Tawagi MD@DrKarineTawagi Dra. María Natalia Gandur Quiroga@nataliagandur 引用@🚨⭐ #ESMO26 | GU ONCOLOGY — DAY 2 HIGHLIGHTS A major day for bladder and prostate cancer: practice-relevant phase III data, longer survival follow-up and new molecular clues. 🟠 VOLGA | LBA2 — A pivotal MIBC result In cisplatin-ineligible/refusing MIBC, perioperative durvalumab + neoadjuvant enfortumab vedotin vs radical cystectomy ± approved adjuvant therapy: ✅ 2-year EFS: 64% vs 45% | HR 0.51 ✅ 2-year OS: 78% vs 69% | HR 0.58 A meaningful survival signal, but not a head-to-head comparison with EV + pembrolizumab. 🔵 DASL-HiCaP | LBA4 — Intensification with radiotherapy Darolutamide + ADT + RT improved 4-year metastasis-free survival to 95% vs 88% (HR 0.42) in very-high-risk prostate cancer. OS remains immature; this use is investigational. 🔵 PEACE-1 | 2215O — Durability matters After 7.7 years' follow-up in de novo mCSPC, ADT + docetaxel + abiraterone delivered median OS of 6.2 vs 4.4 years (HR 0.68). Eight-year OS: 40.3% vs 27.1%. 🔵 PROTEUS substudy | LBA53 Perioperative apalutamide + ADT around prostatectomy vs surgery alone in high-risk localised disease: ✅ EFS HR 0.38 (n=408). Promising but setting-specific evidence; longer follow-up matters. 🧬 STAMPEDE / Decipher | 2045O Genomic risk may help identify patients deriving greater benefit from abiraterone for distant-metastasis prevention. Retrospective biomarker evidence—not yet a mandate to de-escalate. 🟠 NIAGARA molecular analysis | 4741RO Exploratory EFS signals across several molecular subtypes, including basal-squamous disease. No validated biomarker yet to withhold perioperative durvalumab. 🟠 EV-103 | 4740RO Long-term EV + pembrolizumab follow-up in advanced urothelial cancer: ✅ Estimated 5-year OS: 33% in pooled cohorts. Durability and late toxicity both matter. 🟠 GDFATHER-NEO | 4757RO Visugromab + nivolumab: ✅ pCR 33.3% vs 7.7% with nivolumab + placebo. Exciting but exploratory (n=28 evaluable). ⭐ MY CLINICAL PEARL Not every form of intensification is equal. What matters is proven survival or metastasis prevention, alongside toxicity, patient selection and quality of life. Precision AND durable benefit—not just higher response rates. @gbanna74 @ravikanesvaran @nataliagandur @neerajaiims @Sebastiano_Buti @CinziaConted @dralishadamani @amg120395 @PGrivasMDPhD @koshkin85 @MicheleMaffezz @ParamMariappan @dmukherji @VanitaNoronha @montypa @DanieleRaggi83 @PasRescigno @jteoh_hk @alison_tree @DrYukselUrun @yekeduz_emre @AgrawalTrush @AndrewKevinAlo1 #ESMO26 #GUOncology #BladderCancer #ProstateCancer #MIBC #mCSPC #PrecisionOncology
Rodrigo Sanchez Roger@RodRogSan Petros Grivas@PGrivasMDPhD 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
Martín Angel@Martin_AngelMD KolPulseAI@KolPulseAI Mauricio Z Baptista@mzbaptista Alan Tan@alantanmd