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 · 3132 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.orgDavid H Aggen, MD PhD@Dr_Aggen Volga EFS and OS for Durva/EV and Durva/Treme #ESMO26 #oncoalert
Shankar Siva@_ShankarSiva JNCI@JNCI_Now Álvaro Pinto@dralvaropinto OncLive.com@OncLive 🔬 GU cancer data to watch at #ESMO26:
DCockrellMD@DCockrellMD Same topic VOLGA · 52 peopleLBA24734Opembrolizumab#BLADDERCANCER#VOLGA#KEYNOTEB15#CTDNA175 views3 likes1 repost0 repliesJulian Chavarriaga@chavarriagaj Same topic VOLGA · 52 peopleKEYNOTE-905KEYNOTE-B15durvalumabtremelimumab72 views1 like2 reposts0 repliesMario Balsa@MarioBalsaMD 👑 This is why #Podium2Screen works!
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 Kudos @tompowles1 on a fantastic #VOLGA presidential @ #ESMO26 👏
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 🇬🇧 Brilliant to see @tompowles1 AGAIN on the podium, leading the way in bladder cancer!
International Urology Cancer Summit@urologysummit 🚨 #IUCS Clinical Poll | #ESMO26
International Urology Cancer Summit@urologysummit 🚨⭐ #ESMO26 | GU ONCOLOGY — DAY 2 HIGHLIGHTS
Same topic VOLGA · 52 peopleDASL-HICAPLBA2LBA42215OLBA532045O4741RO4740RO33 views1 like0 reposts0 repliesOncology Learning Network@OncLearnNetwork Julian Chavarriaga@chavarriagaj Abeid Athman (Omar).@bin_abeid Ahmed Alanazi | أحمد العنزي@alanazi002 ESMO - Eur. Oncology@myESMO Same topic VOLGA · 52 peopleenfortumabdurvalumab#BLADDERCANCER#MIBC#CLINICALTRIAL#INSIGHTSBYESMO137 views1 like0 reposts0 repliesYakup 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 Amanda Nizam, MD@AmandaNizamMD #ESMO26 | Abstract #LBA2 | VOLGA | Presented by @tompowles1 | @OncoAlert
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
Elisabetta Bonzano MD, PhD@to_be_elizabeth 📌 An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session
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
Same topic VOLGA · 52 peopledurvalumabtremelimumabenfortumab#PODIUM2SCREEN18 views0 likes0 reposts0 repliesUrology Times@UrologyTimes OncoHULA@OncoHULA