Axel S. Merseburger retweeted
Why ‘More Drugs’ Isn’t Always Better: VOLGA Trial Redefines #BladderCancer Care
#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
nejm.org/doi/full/10.1056/NE…
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
Axel S. Merseburger retweeted
Thank you Colleagues for a phenomenal #ESMO26
ESMO in Madrid is a wrap, and we are grateful to everyone who shared, discussed, debated and amplified the science this week. You turned five days in Madrid into a truly global conversation. 🌍 OUR Network's MISSION: Keep our colleagues worldwide Up To date in REAL TIME.
📣 101.7M impressions of potential reach
💬 6.1K posts on X from 988 participants in 34 countries
⚡ 43.1 posts per hour across the meeting days
😊 45% positive sentiment, with only 6% negative
Real-time metrics powered by ACUVOX. WWW.ACUVOX.IO
🏆 Top influencers
@DrChoueiri, @StephenVLiu, @PTarantinoMD, @dr_yakupergun, @HHorinouchi, @zklaassen_md, @stolaney1, @ArndtVogel, @DrYukselUrun, @DraMartinezLago, @tompowles1, @SuyogCancer, @adamfeuerstein, @ScaltritiLab, @GIMedOnc, @ScottGottliebMD, @barriere_dr, @_ShankarSiva, @miriamgonp, @TiansterZhang, @matteolambe, @NiuSanford, @christine_lovly, @amerseburger, @GlopesMd, @montypal, @Icro_Meattini, @PGrivasMDPhD, @brian_rini, @CathyEngMD, @apolo_andrea, @AndreaNecchi, @DrSGraff, @graokane, @to_be_elizabeth, @ElisaAgostinett, @nataliagandur, @UOzkerim, @DrMirallas, @Lucarecco, @mzugman, @p_ciracimd, @DrVilmaPBarcia, @MarioBalsaMD, @scocmem, @GaiaGriguolo, @JankovicK, @Dr_Oncologista
🌎 Where the conversation came from
North America led with 1,940 posts, followed closely by Europe with 1,777. Boston, Madrid and New York were the most active cities.
🔬 Top studies by impact
1️⃣ DeLLphi-305 (SCLC): 4.0M reach, 170 posts
2️⃣ VOLGA (bladder): 3.7M reach, 141 posts
3️⃣ KRASCENDO-1 (NSCLC): 3.5M reach
4️⃣ SAFFRON (NSCLC): 3.3M reach
5️⃣ INTerpath-001 (melanoma): 154 posts
Pinging our Collaborators
Axel S. Merseburger retweeted
🚨 FDA NEWS | By colleagues, for colleagues
Talazoparib + enzalutamide now approved for mAPMN/S prostate cancer with HRR gene mutations.TALAPRO-3 delivered a clear rPFS benefit (HR 0.48).
Full details & Key Facts graphic below.#OncoAlert #ProstateCancer #FDA
fda.gov/drugs/resources-info…
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
Just happened today👏🎉👉 @FDA approved Talazoparib + enzalutamide for pts with HRRm positive mAPMS/mHSPC #prostatecancer FDA Link👉 l1nq.com/ltlq6jk 👉 @NEJM paper tinyurl.com/vkvra8cd 👇 @ASCO @oncoalert @urotoday @PCF_Science @DanaFarber_GU
Breaking news #ASCO26 Adding Talazoparib to enzalutamide significantly ⬆️ rPFS 👉 HR 0.48 in pts w/ mCSPC (mAPMS) #prostatecancer w/ HRRm 👉 @NEJM paper tinyurl.com/vkvra8cd 👇 @ASCO @oncoalert @urotoday @PCF_Science @OpenMedicineHQ
Axel S. Merseburger retweeted
NEWS: Today, FDA approved a new treatment for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. fda.gov/drugs/resources-info…
Axel S. Merseburger retweeted
Dear colleagues,
We are already curating THE COMPLETE #ESMO26 NEWSLETTER 📰 our picks of the top trials presented in Madrid, together in one email.
Register to receive it 👉 buff.ly/N5gYtAc
Every newsletter is curated by oncologists, for colleagues working in cancer care. It’s our way of making science quick and accessible.
We are OncoAlert🚨 For Colleagues, by Colleagues
Best,
The Network
@cdanicas @hoperugo @DrChoueiri @TiansterZhang @matteolambe @NiuSanford @stolaney1 @christine_lovly @amerseburger @GlopesMd @tompowles1 @montypal @Icro_Meattini @PGrivasMDPhD @brian_rini @CathyEngMD @apolo_andrea @AndreaNecchi @DrSGraff @BenWestphalen @graokane @to_be_elizabeth @ElisaAgostinett @nataliagandur @UOzkerim @DrMirallas @DrYukselUrun @Lucarecco @mzugman @HHorinouchi @p_ciracimd @DraMartinezLago @DrVilmaPBarcia @GIMedOnc @MarioBalsaMD @scocmem @AmandaNizamMD @GaiaGriguolo @JankovicK @Dr_Oncologista @Erman_Akkus @WeOncologists @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
The #OncoAlertTOPTweet Day 3 #ESMO26
Post by @OncoAlert 🚨
LITESPARK 012
Adding belzutifan or quavonlimab to pembrolizumab plus lenvatinib does not improve outcomes and increases treatment discontinuation, supporting pembrolizumab plus lenvatinib as a first-line standard of care in advanced ccRCC. #KidneyCancer
Pinging Our 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, @niklas_kluemper @Markuseckstein3
🚨 #ESMO26 #Podium2Screen: LITESPARK-012 in advanced #RCC
Our @OncoAlert founding faculty @DrChoueiri presents
➡️ Adding belzutifan or CTLA-4 blockade (quavonlimab) to pembrolizumab + lenvatinib did NOT improve PFS, OS or ORR (n=1688)
@tompowles1 @MVossMD @ERPlimackMD
@HowardGurney @brian_rini
➡️ Higher discontinuation rates in the triplet arms
Pembro + lenvatinib remains a 1L standard 👇
#KidneyCancer
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
The #OncoAlertTOPTweet Day 3 #ESMO26
Post @OncoAlert
Presenter @montypal 🇺🇸 of @cityofhope
XmAb819
XmAb819 demonstrates promising antitumor activity in heavily pretreated ccRCC, supporting further development despite substantial treatment-related toxicity. #KidneyCancer
Pinging Our 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, @niklas_kluemper @Markuseckstein3
OncoAlert #Podium2Screen🚨 #ESMO26
XmAb819 in #RCC
Our @OncoAlert founding faculty @montypal 🇺🇸presents a first-in-class ENPP3 x CD3 bispecific in heavily pretreated ccRCC:
➡️ ORR 27%, DCR 68%
➡️ Activity after prior HIF-2α inhibitor (ORR 26%)
➡️ 15/16 responders still on treatment
#KidneyCancer
@AlbigesL, @MehmetAsimBilen
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
The #OncoAlertTOPTweet Day 3 #ESMO26
Post @OncoAlert 🚨
Presenter @DrDanielHeng 🇨🇦
LITESPARK 11
Belzutifan plus lenvatinib improves disease control and response durability versus cabozantinib after anti–PD-(L)1 therapy in advanced clear-cell renal-cell carcinoma, without a statistically significant overall survival benefit.
#kidneycancer
Pinging Our 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, @niklas_kluemper @Markuseckstein3
OncoAlert 🚨 #ESMO26 #Podium2Screen
LITESPARK-011 final analysis in #RCC
Our @OncoAlert founding faculty @DanielHengMD 🇨🇦 presents belzutifan + lenvatinib vs cabo after anti–PD-(L)1:
➡️ PFS HR 0.74 (14.8 vs 10.8 mo)
➡️ ORR 53% vs 40%, DOR 22.0 vs 11.9 mo
➡️ OS HR 0.85, not significant
👇 #KidneyCancer #GUOnc
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
Honoured to have had the opportunity to present "Optimal induction treatment in non-metastatic bladder cancer" at #ESMO26 in Madrid!
🚨 Does a deeper pathological response translate into greater survival benefit in perioperative MIBC?
An intriguing pattern across four phase III trials:
🔹 NIAGARA: ΔpCR +10 pp | EFS HR 0.68
🔹 KEYNOTE-B15: +23 pp | HR 0.53
🔹 VOLGA: +32 pp | HR 0.51
🔹 KEYNOTE-905: +49 pp | HR 0.40
Larger absolute pCR gains appear to track with greater EFS benefit.
But the comparator matters!
KEYNOTE-905 and VOLGA used surgery-based controls without neoadjuvant systemic therapy (control "pCR" ~8–9%), whereas NIAGARA and KEYNOTE-B15 used active neoadjuvant cisplatin-based chemotherapy.
Thus, the magnitude of ΔpCR is not directly comparable across trials.
The key question: Can pCR, combined with utDNA + ctDNA clearance, become a reliable tool for response-adapted treatment intensity?
⚠️ This is an exploratory, trial-level observation—not proof that pCR improvements cause EFS benefits or that pCR is a validated surrogate endpoint!
Better biomarkers could help us maximize cure while minimizing overtreatment. 🔬
#ESMO26 #BladderCancer
@weoncologists @urotoday @Uromigos
@OncoAlert 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 @Markuseckstein3
Axel S. Merseburger retweeted
OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Perioperative Durvalumab With or Without Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial
@tompowles1 @jteoh_hk @CPRT65
🔬 Phase 3 (n=695): perioperative durvalumab ± tremelimumab + neoadjuvant enfortumab vedotin vs control (RC, then observation or approved adjuvant therapy) in cisplatin-ineligible MIBC. Interim analysis; median EFS follow-up 22.9 mo.
➡️ D+EV: EFS HR 0.51 (0.38–0.67); OS HR 0.58 (0.40–0.83)
➡️ D+T+EV: EFS HR 0.61 (0.47–0.80); OS did not meet significance
➡️ pCR 45% (D+EV) vs 10% (control); grade 3/4 TRAEs 30% and 42%
✅ Both EFS primary endpoints met; perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS.
🎙️ Thomas Powles
👥 Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto
(4Sight Made from Abstracts publicly available at the ESMO website)
@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
Axel S. Merseburger retweeted
OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Darolutamide With Androgen Deprivation Therapy (ADT) and Definitive or Salvage Locoregional Radiation Therapy (RT) for Localised, Very High-Risk Prostate Cancer: Interim Analysis of an International, Placebo-Controlled, Randomised Phase 3 Trial (DASL-HiCaP; ANZUP1801)
@niazi_Dr7 @seanmmcbride @DocJarad @RayMcDermott1
🔬 Phase 3 (n=1106): darolutamide vs placebo added to 96 weeks of ADT plus prostate/pelvic RT in very high-risk localized or post-prostatectomy persistent/recurrent prostate cancer. Interim analysis; median follow-up 3.8 years.
➡️ 4-yr MFS 95% vs 88%; HR 0.42 (0.27–0.66); p=0.0001
➡️ PSA-PFS HR 0.47 (0.33–0.67); OS HR 0.88 (0.49–1.59)
➡️ Grade ≥3 AEs 43% vs 36%
✅ Darolutamide significantly improved MFS-CI; follow-up is ongoing to confirm MFS-CI surrogacy for OS. #ProstateCancer
🎙️ Tamim Niazi
👥 Sean McBride · Scott Williams · Ian Davis · Martin Stockler · Andrew Martin · Karen Bracken · Felicia Roncolato · Lisa Horvath · Shomik Sengupta · Jarad Martin · Tee Lim · Simon Hughes · Raymond McDermott · James Catto · Paul Kelly · Wendy Parulekar · Scott Morgan · Ricardo Rendon · Christopher Sweeney
(4Sight Made from Abstracts publicly available at the ESMO website)
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Axel S. Merseburger retweeted
OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Results From a Phase 3 Trial of Neoadjuvant Chemotherapy Alone vs in Combination With Nivolumab Followed by Postsurgical Adjuvant Nivolumab in Patients With Muscle-Invasive Bladder Cancer (MIBC)
🔬 Phase 3 (n=653): neoadjuvant nivolumab + gemcitabine/cisplatin then adjuvant nivolumab vs neoadjuvant GC in MIBC. Primary endpoints: EFS and pCR.
➡️ EFS HR 0.94 (95.74% CI 0.71–1.25); P=0.67
➡️ pCR 39.1% vs 29.6%; OR 1.54 (99.91% CI 0.88–2.69)
➡️ OS immature: HR 0.88 (0.64–1.21); grade ≥3 TRAEs 45.9% vs 49.5%
✅ No statistically significant differences in EFS or pCR; safety of nivolumab + GC consistent with the individual agents.
🎙️ Andrea Necchi
(4Sight Made from Abstracts publicly available at the ESMO website)
Pinging Our 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, @niklas_kluemper @Markuseckstein3
Happy to see some posters with good visuals and less text 📚I can remember and understand in 5 minutes poster walk 🚶 at @myESMO #ESMO26
Take home: BRAC-1/2 not more prevalent in young men @OncoAlert
Axel S. Merseburger retweeted
🚨⭐🟠 #ESMO26 | Abstract 4733O | KEYNOTE-905 / EV-303
Perioperative Pembrolizumab or Enfortumab Vedotin + Pembrolizumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer: Ad Hoc Analysis
🎤 Presented by Anders Ullén 🇸🇪
@OncoAlert
🔬 What is the contribution of each agent to the benefit of perioperative EV + pembrolizumab?
📊 STUDY DESIGN
Exploratory 3-arm analysis | N=255
Patients with #MIBC ineligible for or declining cisplatin, concurrently randomized to:
🟢 EV + pembrolizumab (n=85)
🔵 Pembrolizumab alone (n=83)
🔴 Radical cystectomy + PLND alone (n=87)
📊 KEY RESULTS
✅ OVERALL SURVIVAL
🔹 EV + pembro vs control:
HR 0.48 (95% CI 0.29–0.80)
🔹 Pembro vs control:
HR 0.76 (95% CI 0.48–1.20)
📈 Median OS:
• EV + pembro: NR
• Pembro: 51.0 months
• Control: 41.7 months
✅ PATHOLOGICAL COMPLETE RESPONSE
🟢 EV + pembro: 58.8%
🔵 Pembro: 25.3%
🔴 Control: 10.3%
Absolute differences vs control:
• EV + pembro: +48.6 percentage points
• Pembro: +15.7 percentage points
📌 EFS and OS favored perioperative EV + pembro versus surgery alone, while pembrolizumab monotherapy showed numerically favorable outcomes.
⚠️ SAFETY
Grade ≥3 AEs:
• Neoadjuvant: 44.0% vs 20.7% (EV + pembro vs pembro)
• Adjuvant: 60.0% vs 44.9%
🔬 INTERPRETATION
The efficacy pattern supports a potential contribution of both EV and pembrolizumab.
However, this was an ad hoc exploratory analysis, and comparisons should not be interpreted as confirmatory evidence of the independent contribution of each drug.
⭐ MY POINT OF VIEW | CLINICAL PEARL
The question is evolving from whether perioperative EV + pembrolizumab works to understanding why the combination works—and which patients truly need both agents.
The striking pCR difference and favorable OS signal reinforce the biological rationale for combining an ADC with immune checkpoint inhibition.
💡 But treatment intensification must always be balanced against toxicity, patient fitness and long-term benefit.
📌 EV + pembrolizumab is an established perioperative option for cisplatin-ineligible MIBC based on the parent KEYNOTE-905 trial. These exploratory findings add insight rather than establish a new treatment indication.
🌍 GU Oncology Community
@gbanna74 @ravikanesvaran @urologysummit
@tompowles1 @brian_rini @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @BraunMDPhD @cdanicas @AOmlin @declangmurphy @salvolarosa @RenuEapen @seanmcbride @DrJaVallejo
@ecancer @UrologyTimes @urotoday @wearemedsir @OpenMedicineHQ @UCSFCancer
#BladderCancer #MIBC #GUOncology #ADC #ClinicalTrials
Axel S. Merseburger retweeted
🇪🇸 #ESMO26 Day 1 in numbers 📊 and it Just got Started
🔥 17.9M impressions
💬 1.1K posts
👥 437 participants
🌍 26 countries
⚡ 18.7 posts/hour
Proud to lead the conversation at #1 💪 Thank you @myESMO and everyone sharing the science from Madrid 🙌
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@cdanicas @hoperugo @DrChoueiri @TiansterZhang @matteolambe @NiuSanford @stolaney1 @christine_lovly @amerseburger @GlopesMd @tompowles1 @montypal @Icro_Meattini @PGrivasMDPhD @brian_rini @CathyEngMD @apolo_andrea @AndreaNecchi @DrSGraff @BenWestphalen @graokane @to_be_elizabeth @ElisaAgostinett @nataliagandur @UOzkerim @DrMirallas @DrYukselUrun @Lucarecco @mzugman @HHorinouchi @p_ciracimd @DraMartinezLago @DrVilmaPBarcia @GIMedOnc @MarioBalsaMD @scocmem @AmandaNizamMD @GaiaGriguolo @JankovicK @Dr_Oncologista @Erman_Akkus @WeOncologists @niklas_kluemper @Markuseckstein3 @PTarantinoMD @ScottGottliebMD @VivekSubbiah @dr_yakupergun
Axel S. Merseburger retweeted
🚨 Important biomarker signal from #ESMO2026—highly relevant beyond breast cancer!
In the neoadjuvant TALENT trial T-DXd achieved relatively low pCR/near-pCR rates (16–17%) in HER2-low breast cancer.
Importantly, higher baseline HER2 expression was associated with better pathological response, while HER2 expression declined substantially during treatment.
Could the same principle apply to perioperative enfortumab vedotin + pembrolizumab in MIBC?
We urgently need to understand whether low or absent membranous NECTIN4 expression identifies patients less likely to achieve pCR—and potentially at higher risk of recurrence despite EV+pembro.
Histology, quantitative membranous NECTIN4 expression, spatial heterogeneity and ctDNA dynamics should be integrated into prospective biomarker studies. @Markuseckstein3 @DrRosenbergMSK @Dr_Aggen
Precision perioperative therapy must start before cycle 1—not only after cystectomy. 🔬
@OncoAlert 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
Axel S. Merseburger retweeted
🚨 Important new ctDNA data from KEYNOTE-B15 at ESMO 2026!
In cisplatin-eligible MIBC, EV+pembrolizumab achieved:
🔹 82.1% ctDNA clearance during neoadjuvant treatment vs 66.7% with gemcitabine/cisplatin.
🔹 87.0% ctDNA negativity before surgery vs 80.3% with chemotherapy.
🔹 95.2% ctDNA negativity after cystectomy vs 86.5% with chemotherapy.
Strikingly, only 4.8% remained ctDNA-positive after neoadjuvant EV+pembrolizumab and surgery!
We know from IMvigor011 that postoperative ctDNA can identify patients at high risk of recurrence and help guide adjuvant treatment strategies.
But what about patients achieving both pCR and sustained ctDNA negativity?
Do they really need another 5–6 cycles of adjuvant EV, with the potential for cumulative tox/ neuropathy?
Could pCR + ctDNA clearance, followed by longitudinal ctDNA monitoring, define a population suitable for treatment de-escalation?
VOLGA will add another important piece to this puzzle, using only 3 neoadjuvant EV cycles without adjuvant EV.
Of course, neither KEYNOTE-B15 nor VOLGA can establish the necessity of adjuvant EV through cross-trial comparisons.
We urgently need prospective, biomarker-guided de-escalation trials—not simply more treatment for everyone.
@OncoAlert 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 @Markuseckstein3
KEYNOTE-866 did not show EFS not OS. Great presentation 👏🏼by Prof Jens Bedke #ESMO26 @OncoAlert @Uromigos @urotoday @Uroweb @DGUrologie @high5md
Axel S. Merseburger retweeted
🚨 What does enfortumab vedotin really add to perioperative pembrolizumab in MIBC? #ESMO2026
Exciting new data from KEYNOTE-905 at ESMO 2026!
In 255 concurrently randomized, cisplatin-ineligible patients:
🔹 Pembrolizumab alone: pCR 25%, 2-year EFS 56%, EFS HR 0.71 vs cystectomy alone.
🔹 EV + pembrolizumab: pCR 59%, 2-year EFS 76%, EFS HR 0.40 vs cystectomy alone.
A striking difference in pathological response!
The key question: Which patients truly need EV in addition to immunotherapy?
We urgently need predictive biomarkers to guide treatment selection and avoid unnecessary toxicity.
🎤 Happy to discuss optimal induction therapy in non-metastatic bladder cancer this Sunday at ESMO 2026!
📍 Special Symposium: Peri-operative management of urothelial cancer
🕟 Sunday, 16:30–16:45 | Barcelona Auditorium, Hall 9
Looking forward to an exciting discussion! 🔬
ESMO 2026 | KEYNOTE-905/EV-303 | Abstract 4733O
@OncoAlert 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 @Markuseckstein3











































