BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate, with investigator's choice of docetaxel or cabazitaxel in patients with metastatic castration-resistant prostate cancer
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 2740 条
docetaxel
★★★晚破15 人 · 18 条 · 3 篇摘要
本事件热度走势
当前热度 3·可比范围峰值 5(10月24日 17:00)·近 24 小时可比范围变化 –·当前参与者 7
多西他赛在前列腺癌中的奠基性地位来自 TAX 327 Ⅲ 期试验,该研究在激素难治性转移性前列腺癌中证实,每三周 75 mg/m² 多西他赛联合泼尼松较米托蒽醌联合泼尼松显著降低死亡风险(HR 0.76,95% CI 0.62–0.94,P=0.009)[5]。这一确立了多西他赛作为晚期前列腺癌标准化疗骨干的地位,随后的强化治疗探索均以其为对照或组分。
本次 ESMO 会议呈现了多组涉及多西他赛的新数据。PEACE-1 Ⅲ 期长期随访(中位 7.7 年,n=1173)显示,在初发转移性激素敏感性前列腺癌中,阿比特龙联合泼尼松加入标准治疗(ADT ± 多西他赛)显著改善总生存(OS HR 0.75,95% CI 0.65–0.87,P=0.0001);接受 ADT+多西他赛组中位 OS 6.2 年对 4.4 年,8 年 OS 40.3% 对 27.1%,高瘤负亚组 8 年 OS 38% 对 20%,交互作用 P=0.56。TRIDA 真实世界研究评估达罗他胺+ADT+多西他赛治疗 mHSPC,中位随访 11 个月,18 月生存率 86.5%,16.2% 进展为 CRPC,安全性与 ARASENS 相似。PR21 Ⅲ 期比较 ¹⁷⁷Lu-PSMA-617 与多西他赛治疗 mCRPC,患者报告生活质量(FACT-P)在 Lu-PSMA 组维稳、多西他赛组下降,副作用困扰“相当/非常”比例 15% 对 41%,rPFS 无显著差异。Himalayas-1 Ⅲ 期(n=600)以阿比特龙失败 mCRPC 为背景,对比林齐美司汀+达罗他胺与医生选择(ARPI 或多西他赛),主要终点 rPFS。BNT324-03 Ⅲ 期(N≈736)将 B7-H3 ADC Elfe-D 与多西他赛头对头,入组 1–2 线 ARPI 失败、化疗初治 mCRPC,双主要终点 rPFS 与 OS。
这些数据在两个方向推进了认知:一是 PEACE-1 以近 8 年随访确证三联强化(阿比特龙+ADT+多西他赛)在初发 mCSPC 中带来的长期生存获益,且不受瘤负量影响,强化了“早期、足强度”强化治疗的原则;二是 PR21 以患者报告结局为核心,展示 Lu-PSMA 在 mCRPC 一线化疗位点上相对多西他赛的生活质量优势,为治疗排序提供非生存终点支撑。同时,Himalayas-1 与 BNT324-03 仍在招募,分别以多西他赛为对照探索 PRC2 抑制剂联合 ARPI 与 B7-H3 ADC,反映多西他赛仍是新药开发的标准比较基准。
局限在于:PEACE-1 尽管随访长,但三联组毒性累积与后续治疗异质性未在摘要中详述;TRIDA 为单臂真实世界队列,随访仅 11 个月,OS 尚未成熟;PR21 以生活质量为主要叙事,rPFS 无差异且 OS 数据待报;Himalayas-1 与 BNT324-03 仍处招募期,疗效与安全性均待确认。最优三联选择、生物标志物导向的排序、以及可及性与毒性的平衡仍需进一步证据。
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Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study
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.orgTom Powles@tompowles1 ABBV-969 dual-targeting ADC #ESMO26 MOA = PSMA/STEAP1— TOPO1 在转移性去势抵抗性前列腺癌中出现深度缓解 这款药肯定能击败多西他赛?
OncoAlert@OncoAlert Zach Klaassen@zklaassen_md Dra. María Natalia Gandur Quiroga@nataliagandur 引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Long-Term Overall Survival With Abiraterone Acetate Plus Prednisone in the PEACE-1 Phase 3 Trial for De Novo Metastatic Castration-Sensitive Prostate Cancer (mCSPC) @RayMcDermott1 @BertrandTOMBAL 🔬 Phase 3, 2×2 factorial (n=1173): abiraterone and/or prostate RT added to SOC (ADT ± docetaxel) in de novo mCSPC. Median follow-up 7.7 y. ➡️ Abiraterone: OS HR 0.75 (0.65–0.87); p=0.0001 ➡️ ADT + docetaxel ± abiraterone: median OS 4.4 vs 6.2 y; 8-year OS 27.1% vs 40.3% ➡️ High-volume: 8-year OS 20% vs 38%; interaction by metastatic extent p=0.56 ✅ Major OS benefit of adding abiraterone to SOC, irrespective of metastatic extent; triplet associated with almost twice as many long-term survivors in some subgroups. #ProstateCancer 🎙️ Karim Fizazi 👥 Stéphanie Foulon · Joan Carles · Guilhem Roubaud · Ray McDermott · Aude Fléchon · Bertrand Tombal · Stéphane Supiot · Dominik Berthold · Philippe Ronchin · Gabriel Kacso · Gwenaëlle Gravis · Fabio Calabro · Jean-François Berdah · Ali Hasbini · Marlon Silva · Antoine Thiery-Vuillemin · Igor Latorzeff · Loïc Mourey · Brigitte Laguerre · Sophie Abadie-Lacourtoisie · Etienne Martin · Claude El Kouri · Anne Escande · Alvar Rosello · Nicolas Magne · Friederike Schlurmann · Frank Priou · Marie-Eve Chand-Fouche · Salvador Villà Freixa · Muhammad Jamaluddin · Isabelle Rieger · Alberto Bossi (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
Tian Zhang, MD, MHS, FASCO (@tiansterzhangmd.bsky)@TiansterZhang Deborah Mukherji@dmukherji Toni Choueiri, MD@DrChoueiri Gil Morgan, MD@weoncologists Zach Klaassen@zklaassen_md Deborah Mukherji@dmukherji Kenrick Ng@Kenrickng1 UroToday.com@urotoday UroToday.com@urotoday Julian Chavarriaga@chavarriagaj Ricardo Sánchez-E@tioriri OncoDaily RT@OncoDailyRT ScienceLink@sciencelinkonco Martin ZapataLaguado@zapatalaguadomd