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 Congress 2026
October 23–27, 2026 · Madrid · 3101 items
VOLGA
★★★Late-breaking52 people · 73 posts · 2 abstracts
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Heat now 30·Peak in the comparable set 36 (Oct 25 02:00)·Change over 24h in the comparable set –·Participants now 47
First, a retrieval-level coincidence needs clarifying: the entries in the background literature corresponding to "VOLGA" all belong to genetics research on the "Volga German" kindreds, namely the early-onset familial Alzheimer's disease locus linked to chromosome 1q31-42 [3], the N141I missense mutation in the STM2 (i.e., PSEN2) gene in these kindreds [1], and the VHL Arg200Trp mutation of Chuvash polycythemia endemic to the mid-Volga River region [5]. These papers share only a geographic name with the VOLGA bladder cancer trial reported at ESMO26 and have no scientific connection, so they are not cited as class evidence. What actually establishes the existing standard in this field, and was repeatedly mentioned on site, is the positive result of NIAGARA (perioperative durvalumab plus chemotherapy) and the fact that perioperative EV plus pembrolizumab has been called the current standard of care (SOC) in MIBC by experts including PGrivas.
At this meeting, VOLGA was presented as LBA2 in a presidential symposium and was among the trials most discussed by physicians in posts before the congress. The population was cisplatin-ineligible or cisplatin-refusing MIBC patients; according to the live posts, the regimen was neoadjuvant EV plus perioperative durvalumab (Tawagi's post wrote it as durva/treme/EV, with the exact composition to be confirmed), and it significantly improved both EFS and OS: EFS HR 0.55, with 24-month rates of 78% vs 69%; OS HR 0.58, with 24-month rates of 83% vs 75%; pCR 45% vs 10%. Notably, EV was given only in the neoadjuvant setting with no adjuvant EV, unlike KEYNOTE-905/EV-303 where EV also covers the adjuvant phase. The same session also reported KEYNOTE-866 (gemcitabine/cisplatin plus pembro or placebo): it did not meet its primary endpoint, with pCR 44.4% vs 35.8% but neither EFS nor OS statistically significant, in contrast with the positive NIAGARA. Another post noted that VOLGA is now under priority review.
Relative to existing knowledge, the step forward by VOLGA lies in answering the de-escalation question raised by DCockrell: given that EV+IO has already markedly improved MIBC outcomes, can postoperative EV be omitted to build a less toxic perioperative paradigm? In a chemotherapy-limited cisplatin-ineligible population, neoadjuvant EV plus perioperative durvalumab delivered benefit in both EFS and OS, with a wide pCR gap (45% vs 10%), suggesting that a shorter EV exposure may preserve efficacy; set against the failed KEYNOTE-866 in the same session, the failure of the PD-1 plus chemotherapy path also highlights the differentiated value of ADC combined with IO. The limitations are that all figures above are relayed from live posts, surgical outcomes, toxicity, and subgroup details were not disclosed, and the session discussion and full data remain to be confirmed; in addition, posts differ on the regimen components (whether tremelimumab was included), so the formal publication should be authoritative.
- 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 ★★★Same topic VOLGA · 52 peopleKEYNOTE-B15KEYNOTE-866DASL-HICAPCAPITELLO-281LITESPARK-011ivonescimab#BLADDERCANCER#PROSTATECANCER10799 views58 likes32 reposts0 repliesTom Powles@tompowles1 Toni Choueiri, MD@DrChoueiri Karine Tawagi MD@DrKarineTawagi Lovely walking tour & sunset in Madrid @myESMO #ESMO26
OncoAlert@OncoAlert An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session
★★★Same topic VOLGA · 52 peopledurvalumabtremelimumabenfortumabMET#PODIUM2SCREEN1093 views19 likes13 reposts0 repliesTom 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 VOLGA: OS benefit without adjuvant EV.
Karine Tawagi MD@DrKarineTawagi Full house for Bladder/RCC updates first with #KN866 #ESMO26
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 Same topic VOLGA · 52 peopleINTERPATH-001LITESPARK-011DASL-HICAPLBA2#GUONC1026 views21 likes5 reposts2 repliesDr Amol Akhade@SuyogCancer Yakup Ergün@dr_yakupergun #ESMO26 | VOLGA | Presidential Symposium-1
Dra. María Natalia Gandur Quiroga@nataliagandur 🚨 #ESMO26 GU Oncology — the studies I would keep closest on the radar
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
Same topic VOLGA · 52 peopleKEYNOTE-B15KEYNOTE-866DASL-HICAPCAPITELLO-281LITESPARK-011LITESPARK-012ivonescimab#BLADDERCANCER461 views10 likes4 reposts0 repliesDavid H Aggen, MD PhD@Dr_Aggen VOLGA shows Improved EFS and OS for Durva/EV presented by @tompowles1 #ESMO26 #oncoalert
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 OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Oriol Mirallas MD@DrMirallas 🔥 Presidential Symposium I #ESMO26
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 The #ESMO26 Presidential Symposium is about to begin! 🔥
Karine Tawagi MD@DrKarineTawagi 🔥 full house before #ESMO26 Presidential:
Same topic VOLGA · 52 peopleDELLPHI-305tarlatamab#INTERPATH001#VOLGA#DELLPHI-305226 views5 likes1 repost1 replyDra. María Natalia Gandur Quiroga@nataliagandur 🚨⭐ #ESMO26 | GU ONCOLOGY — DAY 2 HIGHLIGHTS
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
Same topic VOLGA · 52 peopleDASL-HICAPLBA2LBA42215OLBA532045O4741RO4740RO163 views3 likes2 reposts0 repliesRodrigo Sanchez Roger@RodRogSan 🎯 #ESMO2026 | VOLGA: pueden cambiar la práctica clínica en cáncer de vejiga músculo-invasivo.
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