2879RO
Durvalumab plus definitive chemoradiotherapy versus definitive chemoradiotherapy in patients with locally advanced esophagus carcinoma: ARION PRODIGE 67 randomized phase 2 trial
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 3194 条
durvalumab
晚破23 人 · 24 条 · 6 篇摘要
本事件热度走势
当前热度 15·可比范围峰值 15（10月25日 02:00）·近 24 小时可比范围变化 –·当前参与者 21
参与者计数21
热度走势
深度解读
度伐利尤单抗作为抗PD-L1单抗，其III期证据已在多个瘤种站住脚。在不可切除III期非小细胞肺癌，PACIFIC研究将713例同步放化疗后未进展的患者按2:1随机至度伐利尤单抗（10 mg/kg，每2周，最长12个月）或安慰剂巩固治疗，主要终点之一、经盲态独立中心评审的无进展生存显著获益，后续分析又确认了总生存获益[1][2]。在广泛期小细胞肺癌一线，CASPIAN在23个国家209个中心入组初治患者，按1:1:1比较度伐利尤单抗联合铂类-依托泊苷、再加tremelimumab的三联方案与单纯化疗[4]。在不可切除肝细胞癌一线，HIMALAYA入组1171例，tremelimumab 300 mg单次给药联合度伐利尤单抗1500 mg每4周（STRIDE）的中位总生存为16.43个月，优于索拉非尼的13.77个月，度伐利尤单抗单药为16.56个月[6]；综述亦将该联合列为较索拉非尼总生存更优的方案[5]。类级安全性上，免疫检查点抑制剂的致命性毒性虽罕见但确实存在[3]。
本次会议上该药实际报告的是POP-DURVA研究：在I期三阴性乳腺癌中评估不含化疗的单剂度伐利尤单抗的临床与免疫学效应（n=71）。关键数字为：pCR 1.7%，客观缓解率11.6%，肿瘤缩小41.3%，初始免疫阴性肿瘤中33%转化为炎症表型。现场解读认为，单剂免疫治疗诱导了明显的免疫激活，但病理缓解非常有限，研究的主要价值在于识别免疫治疗敏感性的潜在生物标志物，而非证明去化疗方案的疗效；且这只是15天治疗后的结果，无法确立更长期单药治疗的疗效。同场另一条与该药相关的讨论是：在肌层浸润性膀胱癌围手术期试验中，度伐利尤单抗起效而帕博利珠单抗与纳武利尤单抗失败，原因无人能解释——这只是开放性提问，未伴随新数据。
从证据推进看，POP-DURVA与既往III期研究处在不同层面：PACIFIC、CASPIAN、HIMALAYA回答的是放化疗后巩固或与化疗、CTLA-4抗体联合能否改善生存[1][2][4][6]，POP-DURVA则在单剂、无化疗、仅15天的窗口期设定下考察免疫激活本身的幅度——41.3%的肿瘤缩小与33%的表型转化说明免疫确实被激活，1.7%的pCR则说明这种激活短期内几乎不转化为病理缓解，两者之间的落差正是生物标志物研究的切入点。局限也随之明确：单剂给药、15天观察、n=71的小样本、限定于I期TNBC这一早期人群，既不能外推疗效结论，更无法解释围手术期膀胱癌中PD-L1与PD-1抑制剂成败分化的原因，去化疗路线的可行性仍待确认。
参考来源
- 1.Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer · N Engl J Med 2017
- 2.Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC · N Engl J Med 2018
- 3.Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis · JAMA Oncol 2018
- 4.Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial · Lancet 2019
- 5.Immunotherapies for hepatocellular carcinoma · Nat Rev Clin Oncol 2022
- 6.Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma · NEJM Evid 2022
证据
4737RO
Durvalumab (D) in Combination With BCG Induction and Maintenance (I+M) for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): Early Recurrence and Cystectomy-Free Survival in Patients (pts) With Papillary Only Tumours From POT
https://esmocongress.esmo.orgLBA2
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.orgLBA26
Short-term preoperative durvalumab for stage I TNBC: First results from the phase II UNLOCK 14 - POP-DURVA trial
https://esmocongress.esmo.orgLBA3
Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial
https://esmocongress.esmo.orgLBA37
Durvalumab (D) plus carboplatin/paclitaxel (CP) followed by D with or without olaparib (O) in advanced/recurrent endometrial cancer (a/rEC): Interim overall survival (OS) and safety from the randomised phase 3 DUO-E/GOG-3041/ENGOT-EN10 stud
https://esmocongress.esmo.org现场
AACR 2026 现场信号@ Aya Mohamed | MSc, MD 🎗@Dr_Oncologista Emre Yekedüz@yekeduz_emre AACR 2026 现场信号@ AACR 2026 现场信号@ Yakup Ergün@dr_yakupergun Elisabetta Bonzano MD, PhD@to_be_elizabeth Julian Chavarriaga@chavarriagaj Sara Tolaney@stolaney1 POP-DURVA 术前 TNBC (T1N0) 使用 2 个周期的 durvalumab n=78 pCR: 1.4% @OncoAlert #ESMO26
Matteo Lambertini, MD PhD@matteolambe #ESMO26 的 #BreastCancer 分会场口头摘要：在 cT1 cN0 三阴性乳腺癌患者中，术前使用 #durvalumab，不联合化疗 @OncoAlert @myESMO
C. Michael Gibson MD@CMichaelGibson Dr Amol Akhade@SuyogCancer 3 剂 EV 联合 Durvalumab 应成为这类患者新的 SOC。少即是多。@myESMO @OncoAlert #esmo26 @tompowles1
Philippe Aftimos, MD @aftimosp UT MD Anderson@UTMDAnderson AACR 2026 现场信号@ Yakup Ergün@dr_yakupergun 引用@#ESMO26 | POP-DURVA In stage I TNBC, the clinical and immunological effects of a single dose of durvalumab without chemo were evaluated (n=71). - pCR: 1.7% - Objective response: 11.6% - Tumor shrinkage: 41.3% - Conversion to an inflamed phenotype: 33% of initially immune-negative tumors. A single dose of immunotherapy induced substantial immune activation, but pathological response was very limited. The main value of this study lies in identifying potential biomarkers of immunotherapy sensitivity rather than demonstrating the efficacy of a chemo-free approach. However, results after only 15 days of treatment cannot establish the efficacy of longer-term monotherapy.
Correo Farmacéutico@CFarmaceutico ScienceLink@sciencelinkonco CancerTherapyAdvisor@CancerTherAdvsr OncoHULA@OncoHULA 广泛期小细胞肺癌领域的一项新SoC：Durvalumab联合Tarlatamab。79%的患者存活至1年。#ESMO26 #LungCancer @myESMO @_SEOM @gecp_org
Diario Médico@diariomedico Kristina Jankovic, MD@JankovicK David H Aggen, MD PhD@Dr_Aggen Prof. Dr. Ahmet Dirican@dr_dirican Ritrattodellasalute@ritrattosalute Medinews@Medinews_ Catarina Abreu@catarinaabreupm Joana Ribeiro 在 #ESMO2026 上精彩呈现了关于 durvalumab 在 TNBC 中应答的转化分析
NEJM精选 DeLLphi-305 研究：塔拉妥单抗联合度伐利尤单抗维持治疗广泛期小细胞肺癌
NEJM 在线发表 DeLLphi-305 研究，评估塔拉妥单抗联合度伐利尤单抗作为广泛期小细胞肺癌维持治疗的疗效与安全性。
推荐理由：DeLLphi-305 研究在 NEJM 发表，给出广泛期小细胞肺癌维持治疗塔拉妥单抗联合度伐利尤单抗的关键疗效数据。
NEJM VOLGA试验：度伐利尤单抗联合特雷梅利尤单抗和恩福妥单抗维替妥治疗肌层浸润性膀胱癌
NEJM Ahead of Print 发表 VOLGA 试验结果，评估度伐利尤单抗、特雷梅利尤单抗联合恩福妥单抗维替妥治疗肌层浸润性膀胱癌的疗效。DOI: 10.1056/NEJMoa2608323
临床试验登记 Zolbetuximab联合Durvalumab及FLOT方案用于CLDN18.2阳性胃癌或胃食管交界腺癌的新辅助化疗
日本国立癌症中心启动2期试验（NCT07872722），计划入组29例CLDN18.2阳性局部进展期胃癌或胃食管交界腺癌患者，评估Zolbetuximab联合Durvalumab及FLOT方案新辅助化疗的疗效。主要终点为手术标本的组织学完全缓解率（Grade 3），关键次要终点包括不良事件发生率、治疗完成率及R0切除率。