HLX02与参考曲妥珠单抗在转移性her2阳性乳腺癌中的最新疗效和安全性：一项随机III期等效试验

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2025-02-04 DOI:10.1016/j.breast.2025.104413

Binghe Xu , Qingyuan Zhang , Tao Sun , Wei Li , Yue'e Teng , Xichun Hu , Igor Bondarenko , Hryhoriy Adamchuk , Liangming Zhang , Dmytro Trukhin , Shusen Wang , Hong Zheng , Zhongsheng Tong , Yaroslav Shparyk , Futang Yang , Haoyu Yu , Jing Li , Qingyu Wang , Jun Zhu , HLX02-BC01 Investigators

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引用次数: 0

摘要

在一项III期研究中，来自欧盟（eu -曲妥珠单抗）的HLX02和曲妥珠单抗与多西他赛联合使用之间的完全等效性得到了证实。本研究旨在评估3年随访后的长期疗效和安全性数据。方法先前未经治疗的her2阳性转移性乳腺癌患者接受静脉注射HLX02或eu -曲妥珠单抗（初始剂量为8mg /kg，随后每3周增加6mg /kg，持续12个月）联合多西他赛。主要终点是第24周的总缓解率（ORR24）。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个月后，649例入组患者中有270例死亡；HLX02组有128例（39.5%），eu -曲妥珠单抗组有142例（43.7%）。中位OS为37.3个月（95% CI 36.2，不可评价[NE]），未达到（95% CI 34.2， NE）(分层风险比0.86 [95% CI 0.68, 1.10]；p = 0.229)， 3年OS率分别为57.5%和54.0%。在长期随访评估中，HLX02组的中位PFS为11.7 （95% CI 11.5, 12.1）个月，eu -曲妥珠单抗组的中位PFS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)。在生存随访结束之前，没有新的安全问题报告。结论长期疗效和安全性与前期研究结果一致。HLX02和参考曲妥珠单抗之间没有临床意义的差异。临床试验注册号：chinadrutrials.org CTR20160526（2016年9月12日），ClinicalTrials.gov NCT03084237（2017年3月20日），EudraCT 2016-000206-10（2017年4月27日）。

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Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial

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 (ORR₂₄). 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).

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.