🚨 #ESMO26 | Another perioperative MIBC trial that helps define what doesn’t work — and why that matters.
@OncoAlert @myESMO
In this phase III study presented by @AndreaNecchi, adding nivolumab to neoadjuvant gemcitabine/cisplatin, followed by adjuvant nivolumab, did not significantly improve outcomes versus GC alone in muscle-invasive #BladderCancer.
📊 n=653
➡️ EFS: HR 0.94
P=0.67
➡️ pCR: 39.1% vs 29.6%
OR 1.54, but not statistically significant
➡️ OS: still immature
HR 0.88
➡️ Grade ≥3 TRAEs: 45.9% vs 49.5%
🎯 Why this matters: a numerically higher pCR rate is interesting — but pCR alone cannot substitute for meaningful improvement in EFS or OS.
For me, this trial reinforces an increasingly important principle in perioperative MIBC:
checkpoint inhibition is not a class-effect strategy that can simply be added to every chemotherapy backbone.
The next step is better biological selection:
🧬 ctDNA/MRD
🔬 molecular subtype
🛡️ immune phenotype
🎯 other predictive biomarkers
The goal should not be more perioperative therapy for everyone — but identifying who truly needs intensification.
@AndreaNecchi @PGrivasMDPhD @tompowles1 @apolo_andrea @shilpaonc @niklas_kluemper @Markuseckstein3 @DrYukselUrun @crisbergerot @nataliagandur
#OncoAlert #ESMO26 #MIBC #UrothelialCancer #ctDNA #PrecisionOncology #GUOncology
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Emotional distress (ED) upfront neoadjuvant ipilimumab + nivolumab (IPI+NIVO) is associated with lower pathological response and toxicity
https://esmocongress.esmo.orgResults from a phase 3 trial of neoadjuvant (neoadj) chemotherapy alone vs in combination with nivolumab followed by postsurgical adjuvant nivolumab in patients (pts) with muscle-invasive bladder cancer (MIBC)
https://esmocongress.esmo.orgFinal pathological and radiological outcomes and initial EFS from a blinded, exploratory phase 2 trial of nivolumab ± visugromab in MIBC (GDFather-NEO)
https://esmocongress.esmo.orgPrimary analysis of HBI-8000-303: A randomized phase 3 trial of nivolumab plus HBI-8000 or placebo in advanced melanoma
https://esmocongress.esmo.org- **标题 / Title：** Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)
https://esmocongress.esmo.orgOncoAlert 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在 X 查看被引用的帖子
Source: Dra. María Natalia Gandur Quiroga · x.com