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Dra. María Natalia Gandur Quiroga· @nataliagandur · X·· 18 小时前评分70

nivolumab

正文 · 机器翻译

🚨 #ESMO26 | 又一项围手术期 MIBC 试验,有助于界定什么方案行不通——以及这为何重要。
@OncoAlert @myESMO
在这项由 @AndreaNecchi 公布的 III 期研究中,将 nivolumab 加至新辅助 gemcitabine/cisplatin 治疗中,随后在辅助治疗阶段使用 nivolumab,与单独采用 GC 相比,并未显著改善肌肉浸润性 #BladderCancer 患者的结局。

📊 n=653

➡️ EFS:HR 0.94
P=0.67

➡️ pCR:39.1% vs 29.6%
OR 1.54,但无统计学显著性

➡️ OS:数据仍不成熟
HR 0.88

➡️ ≥3级 TRAEs:45.9% vs 49.5%

🎯 这一点为何重要:pCR 率在数值上更高值得注意——但仅有 pCR 并不能替代 EFS 或 OS 方面有意义的改善。

在我看来,这项试验再次印证了围手术期 MIBC 中一个日益重要的原则:

检查点抑制并非一种类效应策略,不能简单地添加到每一种化疗骨架中。

下一步是更精准的生物学筛选:

🧬 ctDNA/MRD
🔬 分子亚型
🛡️ 免疫表型
🎯 其他预测性生物标志物

目标不应是为所有人提供更多围手术期治疗——而应识别出真正需要强化治疗的人群。

@AndreaNecchi @PGrivasMDPhD @tompowles1 @apolo_andrea @shilpaonc @niklas_kluemper @Markuseckstein3 @DrYukselUrun @crisbergerot @nataliagandur

#OncoAlert #ESMO26 #MIBC #UrothelialCancer #ctDNA #PrecisionOncology #GUOncology

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会议摘要
4736O按 Proffered paper 1: Genitourinary tumour, renal and urothelial 对上

Results 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.org
4757RO按 Rapid oral 1: Genitourinary tumours, renal and urothelial 对上

Final pathological and radiological outcomes and initial EFS from a blinded, exploratory phase 2 trial of nivolumab ± visugromab in MIBC (GDFather-NEO)

https://esmocongress.esmo.org
LBA54按 Proffered paper: Melanoma and other skin tumours 对上

Primary analysis of HBI-8000-303: A randomized phase 3 trial of nivolumab plus HBI-8000 or placebo in advanced melanoma

https://esmocongress.esmo.org
NCT04884282NCT04884282按 - **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) 对上

- **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.org
引用@
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
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来源:Dra. María Natalia Gandur Quiroga · x.com

CBACBA Frontier Insights (CFI)美国华人生物医药科技协会(CBA)www.cba-usa.org