2025年2月5日 · Objectives: The primary objective of TROPION-Breast04 is to evaluate the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy versus standard of care in patients with previously untreated early-stage TNBC or HR-low/HER2- breast cancer.

2024年12月20日 · 本次 ESMO Asia 大会上，一项关于 TROPION-Lung01 和 TROPION-Lung05 研究的汇总分析结果以 LBA 的形式公布，为 Dato-DXd 在 EGFR 突变晚期非小细胞肺癌（NSCLC）后线治疗领域的应用提供了强有力的支持[1]。 对此，「丁香园肿瘤时间」特邀中国医学科学院肿瘤医院/山西省肿瘤医院王洁教授对该汇总分析结果进行深度解读与点评。 EGFR-TKI 作为 EGFR 突变晚期 NSCLC 的一线标准治疗方案，为患者带来了显著的生存获益。 然 …

The TROPION-Breast02 study aims to discover whether Dato-DXd is more effective than standard-of-care chemotherapy, allowing patients with TNBC to live longer without their breast cancer getting worse.

2023年6月30日 · TROPION-Breast01 is an ongoing phase III study that is evaluating the efficacy and safety of Dato-DXd compared with investigator's choice of standard-of-care chemotherapy in patients with inoperable or metastatic HR+/HER2- breast cancer who have received one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting.

2024年9月12日 · In this primary analysis, TROPION-Breast01 met its dual primary PFS end point; Dato-DXd reduced the risk of disease progression or death by 37% versus ICC in patients with inoperable or metastatic HR+/HER2– breast cancer who had received one or two previous lines of chemotherapy in this setting (HR, 0.63; P < .0001 per BICR). Consistent PFS ...

2025年1月30日 · TROPION-Lung12 is a global, multicenter, three-arm, open-label phase 3 trial where patients will be randomized in a 2:1:2 ratio to evaluate the efficacy and safety of adjuvant DATROWAY (6 mg/kg) in combination with rilvegostomig (750 mg) or rilvegostomig (750 mg) monotherapy versus observation or standard of care adjuvant chemotherapy regimens i...

2024年8月11日 · TROPION-Breast05 is a phase 3, randomized, open-label, 3-arm, multicenter, international study; it will randomize about 625 patients (aged 18 years or older) with histologically or cytologically documented locally recurrent inoperable or metastatic PD-L1 positive (CPS 10 or greater) TNBC that has not been previously treated with CT or targeted ...

2023年1月30日 · A comprehensive development program called TROPION is underway globally with more than 10 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple tumors including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer.

2023年10月24日 · 关键性III期临床试验TROPION-Breast01显示，针对既往接受过内分泌治疗且至少一种全身系统性治疗、无法手术或转移性激素受体（HR）阳性，人表皮生长因子受体-2（HER2）低表达或阴性（IHC 0，IHC 1+或IHC 2 + / ISH-）乳腺癌患者，与研究者选择的化疗相比，Datopotamab deruxtecan（Dato-DXd）在无进展生存期（PFS）方面表现出具有统计学意义与临床意义的改善。 这些结果已在西班牙马德里举行的2023年欧洲肿瘤内科学会（ESMO） …

Dato-DXd is an antibody drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload via a plasma-stable tetrapeptide-based cleavable linker. Dato-DXd had encouraging efficacy and manageable safety in heavily pretreated aNSCLC.