
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 4873 条
tucatinib
★★★20 人 · 20 条
本事件热度走势
当前热度 5·可比范围峰值 10(10月26日 19:00)·近 24 小时可比范围变化 –·当前参与者 15
图卡替尼是口服、高选择性的HER2酪氨酸激酶抑制剂[1],其在HER2阳性转移性乳腺癌中的证据基础由随机双盲安慰剂对照的HER2CLIMB研究奠定:在曲妥珠单抗、帕妥珠单抗和T-DM1经治人群中,联合曲妥珠单抗加卡培他滨将1年PFS率从12.3%提高到33.1%(HR 0.54)[1];对291例脑转移患者的探索性分析显示颅内进展或死亡风险降低68%(HR 0.32)[2];最终OS分析随访至中位29.6个月[6]。在化疗难治、HER2阳性、RAS野生型转移性结直肠癌中,II期MOUNTAINEER研究也显示了图卡替尼联合曲妥珠单抗的活性[5]。
本次会上实际报告的是单臂II期BRIDGET研究:47例可评估的HER2阳性转移性乳腺癌患者在孤立性颅内进展、接受SRS治疗后,在继续原曲妥珠单抗/帕妥珠单抗或T-DM1骨架的基础上加用图卡替尼,主要终点为按RANO-BM评估的颅内PFS。现场帖给出的数字是:中位iPFS未达到,6个月、12个月、18个月iPFS分别为91%、64%、59%,≥3级不良事件15%;帖文在颅外结果处被截断,相关数据未披露。同场还有Nancy Lin介绍即将在Dana-Farber启动的II/III期BREnna研究(ZN-A-1041或图卡替尼联合曲妥珠单抗+卡培他滨,用于伴或不伴CNS转移的HER2阳性局部晚期/转移性乳腺癌),另有一条现场帖以极简方式提到HERTOCLIMB维持治疗的生活质量恶化,细节待确认。
主站新闻没有报道BRIDGET本身,而是独立提供了监管侧信息:2026年10月8日FDA批准图卡替尼用于HER2阳性乳腺癌维持治疗[N1]。这与BRIDGET“局部放疗后加药、原有骨架不动”的思路方向一致,即从整体换线转向延续并强化既有抗HER2治疗,但新闻与现场数据之间并无直接对应关系。
就认知推进而言,BRIDGET回应的是一个高度实用的临床场景:颅外病灶控制良好、仅颅内进展时,是否必须整体换方案。18个月iPFS仍达59%、≥3级AE仅15%,提示在HER2CLIMB脑转移人群颅内获益[2]的基础上,“SRS后加用图卡替尼、不动HP或T-DM1骨架”的策略可能带来持久的颅内控制。但局限同样清楚:单臂设计、仅47例可评估、无对照组,中位iPFS未达到提示随访尚不成熟,颅外与生存数据未披露,BREnna尚未开始入组,结论均有待更完整的结果验证。
- 1.Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer · N Engl J Med 2020
- 2.Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial · J Clin Oncol 2020
- 3.Properties of FDA-approved small molecule protein kinase inhibitors: A 2021 update · Pharmacol Res 2021
- 4.HER2-positive breast cancer and tyrosine kinase inhibitors: the time is now · NPJ Breast Cancer 2021
- 5.Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study · Lancet Oncol 2023
- 6.Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis · Ann Oncol 2022
OncoAlert@OncoAlert Erika Hamilton, MD, FASCO@ErikaHamilton9 引用@#ESMO26: Practice-changing improvement in intracranial progression-free survival seen with the addition of tucatinib to standard therapy in HER2-positive metastatic #BreastCancer (#MBC) in the BRIDGET #ClinicalTrial. Read more https://ow.ly/Gc4550ZZO6K #InsightsbyESMO
Sara Tolaney@stolaney1 Aya Mohamed | MSc, MD 🎗@Dr_Oncologista Elisa Agostinetto@ElisaAgostinett Matteo Lambertini, MD PhD@matteolambe Dr Sarah Sammons@drsarahsam Tucatinib 加用 HP 是局部治疗后,一线治疗脑部仅有低肿瘤负荷病变的一种不错选择。 尤其适用于没有颅外病变且不希望出现 ADC 毒性的患者。 #ESMO26
引用@📌 BRIDGET: A phase II trial of tucatinib added to trastuzumab/pertuzumab or ado-trastuzumab emtansine after isolated intracranial progression in patients with advanced HER2-positive breast cancer ✨@drsarahsam #ESMO26 🇪🇸 @OncoAlert #OncoAlertAF
Dra. María Natalia Gandur Quiroga@nataliagandur 引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 BRIDGET: A Phase II Trial of Tucatinib Added to Trastuzumab/Pertuzumab or Ado-Trastuzumab Emtansine After Isolated Intracranial Progression in Patients With Advanced HER2-Positive Breast Cancer @drsarahsam @DrVanSwearingen @rashmikmurthy @CareyAnders1 🔬 Single-arm phase II (47 evaluable): tucatinib added to ongoing HP or T-DM1 after SRS for isolated intracranial progression in HER2+ MBC. Primary endpoint: iPFS (RANO-BM). ➡️ Median iPFS not reached; p<0.0001 vs historical median of 5 mo ➡️ iPFS 91% at 6 mo, 64% at 12 mo, 59% at 18 mo ➡️ Grade ≥3 AEs 15%; extracranial progression 4.3% ✅ Adding tucatinib to HP after radiation met the primary endpoint, with more than half of patients free of intracranial progression at 18 months. #BreastCancer 🎙️ Sarah Sammons 👥 Amanda Van Swearingen · Laura Noteware · Nusayba Bagegni · Kelly Moulton · Stevie Threatt · Denise Jaggers · Shannon Shea · Eric Lipp · Erin Riley · Sin-Ho Jung · Gloria Broadwater · Masey Ross · Kimberly Strickland · Sasha Beyer · Alison Conlin · Aki Morikawa · Rashmi Murthy · Carey Anders (4Sight Made from Abstracts publicly available at the ESMO website) Pinging OncoAlert Breast Cancer Faculty @matteolambe @aftimosp @E_de_Azambuja @DrSGraff @ErikaHamilton9 @hoperugo @stolaney1 @BianchiniGP @aftimosp @kevinpunie @ElisaAgostinett @to_be_elizabeth @GaiaGriguolo @JankovicK @raalbany @JavierCortesMD @JaniceTNBCmets @Prof_Nadia_H @LoiSher @jamecancerdoc @Lucarecco @Dr_Oncologista @guiandri76
Elisabetta Bonzano MD, PhD@to_be_elizabeth Dana-Farber’s Breast Oncology Center@DFCI_BreastOnc Yakup Ergün@dr_yakupergun Mitsuo Terada, MD, PhD@乳腺科医@MamMa_mimumemo Hope Rugo@hoperugo VIRGINIA KAKLAMANI@VKaklamani Kazuki Nozawa, MD@kazuki_nozawa Paolo Tarantino@PTarantinoMD Juliano A Moreira@mjuliano77 HERTOCLIMB tucatinib维持治疗 #ESMO2026 生活质量恶化
ESMO Open@ESMO_Open Encore Medical Education@Encore_Med_Ed ESMO - Eur. Oncology@myESMO