HLX02与对照曲妥珠单抗治疗转移性HER2阳性乳腺癌的疗效和安全性更新：一项随机III期等效性试验
Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial.
作者信息
Xu Binghe, Zhang Qingyuan, Sun Tao, Li Wei, Teng Yue'e, Hu Xichun, Bondarenko Igor, Adamchuk Hryhoriy, Zhang Liangming, Trukhin Dmytro, Wang Shusen, Zheng Hong, Tong Zhongsheng, Shparyk Yaroslav, Yang Futang, Yu Haoyu, Li Jing, Wang Qingyu, Zhu Jun
机构信息
Department of Medical Oncology, National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Beijing, 100021, China.
Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
出版信息
Breast. 2025 Apr;80:104413. doi: 10.1016/j.breast.2025.104413. Epub 2025 Feb 4.
AIM
Equivalence between HLX02 and trastuzumab sourced from the European Union (EU-trastuzumab), in combination with docetaxel, was demonstrated in a phase III study. This study aimed to evaluate the long-term efficacy and safety data after 3 years of follow-up.
METHODS
Patients with previously untreated, HER2-positive metastatic breast cancer received intravenous HLX02 or EU-trastuzumab (initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months) in combination with docetaxel. Primary endpoint was the overall response rate up to week 24 (ORR). Secondary endpoints including updated overall survival (OS), progression-free survival (PFS), safety and immunogenicity are reported in this long-term follow-up analysis.
RESULTS
After a median follow-up duration of 35.0 months, 270 out of the 649 enrolled patients had died; 128 (39.5 %) in the HLX02 and 142 (43.7 %) in the EU-trastuzumab group. Median OS was 37.3 (95 % CI 36.2, not evaluable [NE]) months and not reached (95 % CI 34.2, NE) (stratified HR 0.86 [95 % CI 0.68, 1.10]; p = 0.229), with a 3-year OS rate of 57.5 % and 54.0 %, respectively. Median PFS at this long-term follow-up assessment was 11.7 (95 % CI 11.5, 12.1) months for the HLX02 group and 10.6 (95 % CI 9.5, 11.7) months for the EU-trastuzumab group (stratified HR 0.86 [95 % CI 0.69, 1.06]; p = 0.158). No new safety concerns were reported until the end of the survival follow-up.
CONCLUSION
Long-term efficacy and safety were consistent with the previous findings. No clinically meaningful differences between HLX02 and reference trastuzumab were demonstrated.
CLINICAL TRIAL REGISTRATION
Chinadrugtrials.org CTR20160526 (September 12, 2016), ClinicalTrials.gov NCT03084237 (March 20, 2017), EudraCT 2016-000206-10 (April 27, 2017).
目的
一项III期研究证实了HLX02与源自欧盟的曲妥珠单抗（欧盟曲妥珠单抗）联合多西他赛的等效性。本研究旨在评估3年随访后的长期疗效和安全性数据。
方法
既往未接受过治疗的HER2阳性转移性乳腺癌患者接受静脉注射HLX02或欧盟曲妥珠单抗（初始剂量8mg/kg，随后每3周6mg/kg，持续12个月）联合多西他赛治疗。主要终点为至第24周的总缓解率（ORR）。在这项长期随访分析中报告了次要终点，包括更新的总生存期（OS）、无进展生存期（PFS）、安全性和免疫原性。
结果
中位随访时间为35.0个月，649例入组患者中有270例死亡；HLX02组128例（39.5%），欧盟曲妥珠单抗组142例（43.7%）。中位OS为37.3（95%CI 36.2，不可评估[NE]）个月和未达到（95%CI 34.2，NE）（分层HR 0.86[95%CI 0.68，1.10]；p=0.229），3年OS率分别为57.5%和54.0%。在此次长期随访评估中，HLX02组的中位PFS为11.7（95%CI 11.5，12.1）个月，欧盟曲妥珠单抗组为10.6（95%CI 9.5，11.7）个月（分层HR 0.86[95%CI 0.69，1.06]；p=0.158）。直至生存随访结束，未报告新的安全性问题。
结论
长期疗效和安全性与既往研究结果一致。未显示HLX02与参比曲妥珠单抗之间存在具有临床意义的差异。
临床试验注册
中国药物临床试验登记号CTR20160526（2016年9月12日），美国国立医学图书馆临床试验注册号NCT03084237（2017年3月20日），欧盟临床试验注册号2016-000206-10（2017年4月27日）。
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