QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

期刊论文
出版模式：

开放获取
发表日期：

2024年6月21日

查看全文

Wenjia Zuo,
Zhonghua Wang,
Jun Qian,
Xiaopeng Ma,
Zhaofeng Niu,
Jianghua Ou,
Qinguo Mo,
Jing Sun,
Xinzheng Li,
Qitang Wang,
Yongzhong Yao,
Guohua Yu,
Hongsheng Li,
Dedian Chen,
Hao Zhang,
Cuizhi Geng,
Guangdong Qiao,
Mengmeng Zhao,
Baihui Zhang,
Xiaoyan Kang,
Jin Zhang,
Zhimin Shao

摘要

Background

This randomized, parallel-controlled, double-blinded, phase III equivalence study evaluated the equivalence of a proposed pertuzumab biosimilar QL1209 to the pertuzumab (Perjeta®) each with trastuzumab and docetaxel in neoadjuvant treatment of early or locally advanced breast cancer patients with HER2-positive, ER/PR-negative.

Methods

Eligible patients were randomly (1:1) assigned to receive 4 cycles of neoadjuvant QL1209 or pertuzumab each with trastuzumab and docetaxel, and adjuvant treatment. The primary endpoint was total pathologic complete response (tpCR), with equivalence margins of 0.76 to 1.32.

Results

Among the 585 patients enrolled, 257 and 259 patients were assigned to the QL1209 and pertuzumab groups, respectively. The tpCR rates were comparable in the QL1209 (109/255, 42.75%; 90% CI 37.65 to 47.84) and pertuzumab (117/259, 45.17%; 90% CI 40.09 to 50.26) groups. The tpCR risk ratio was 0.95 (90% CI, 0.80 to 1.11), and the 90% CI fell within the predefined equivalence margin. The most common grade ≥3 treatment-related adverse event was decreased neutrophil count (10. 9% vs. 12.7%) in the QL1209 and pertuzumab groups.

Conclusions

QL1209 demonstrated equivalent efficacy and comparable safety profile to the reference pertuzumab in neoadjuvant treatment of HER2-positive, ER/PR-negative, early, or locally advanced breast cancer.

Trial registration

Chinadrugtrials.org CTR20201073; ClinicalTrials.gov NCT04629846.