Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial

Abstract Purpose: This randomized, double-blind phase 3 equivalence study aimed to evaluate the similarity of neoadjuvant pertuzumab biosimilar HLX11 versus reference pertuzumab plus trastuzumab and docetaxel for human epidermal growth factor receptor 2-positive, hormone receptor-negative early-stage or locally advanced breast cancer (BC). Patients and Methods: Eligible patients were randomly assigned (1:1) to receive 4 cycles of neoadjuvant HLX11 (HLX11 arm) or European Union-sourced pertuzumab, plus trastuzumab and docetaxel (EU-pertuzumab arm). Patients in the respective arms received adjuvant HLX11 plus trastuzumab or were re-randomized (1:1) to receive HLX11 or EU-pertuzumab plus trastuzumab. The primary endpoint was blinded independent central review (BICR)-assessed total pathological complete response (tpCR) rate. Results: In total, 908 patients were randomized to the HLX11 (n = 454) or EU-pertuzumab arm (n = 454); 192 patients in HLX11 arm received adjuvant HLX11; 200 patients in EU-pertuzumab arm were re-randomized to receive adjuvant HLX11 (n = 100) or EU-pertuzumab (n = 100). BICR-assessed tpCR rate (95% confidence interval [CI]) was 46.3% (41.6%–51.0%) and 45.8% (41.2%–50.5%), respectively. The equivalence criteria were met, with relative risk of tpCR (90% CI) of 1.01 (0.90–1.14) and relative difference (95% CI) of 0.47% (−5.99%–6.92%). No clinically meaningful differences were observed in other efficacy endpoints, safety, pharmacokinetics (PK), or immunogenicity. In the adjuvant phase, switching from EU-pertuzumab to HLX11 led to no notable differences in safety, PK, or immunogenicity. Conclusions: Compared with EU-pertuzumab, neoadjuvant HLX11 demonstrated a similar tpCR rate and no clinically meaningful differences in other efficacy endpoints, safety, PK, or immunogenicity in BC.

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Journal
Clinical Cancer Research
Published
2026-09-09
DOI
https://doi.org/10.1158/1078-0432.ccr-26-1604
Primary Topic
HER2/EGFR in Cancer Research
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article
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article

Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial

Xiaobo Du, Yaping Yang, Xiaopeng Ma, Erwei Song et al.
Clinical Cancer Research
HER2/EGFR in Cancer Research
article

Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial

Xiaobo Du, Yaping Yang, Xiaopeng Ma, Erwei Song, Zhaofeng Niu, Min-Ying Li, Zhuorong Chen, Dong Song, Yu Ren, 莫钦国, Xujuan Wang, Tao Huang, 王启堂, Bo Zhang, Jing Li, Jin Zhang, Qiang Liu, Jinhai Zhu, Hongsheng Li, Qingyuan Zhang, Fan Li, Ying Yi, Xiaoyu Liu, Peifen Fu, Haoyu Yu, Qingyu Wang, Futang Yang, Yanlan Fan, Chunwei Xie
article en

Abstract

Abstract Purpose: This randomized, double-blind phase 3 equivalence study aimed to evaluate the similarity of neoadjuvant pertuzumab biosimilar HLX11 versus reference pertuzumab plus trastuzumab and docetaxel for human epidermal growth factor receptor 2-positive, hormone receptor-negative early-stage or locally advanced breast cancer (BC). Patients and Methods: Eligible patients were randomly assigned (1:1) to receive 4 cycles of neoadjuvant HLX11 (HLX11 arm) or European Union-sourced pertuzumab, plus trastuzumab and docetaxel (EU-pertuzumab arm). Patients in the respective arms received adjuvant HLX11 plus trastuzumab or were re-randomized (1:1) to receive HLX11 or EU-pertuzumab plus trastuzumab. The primary endpoint was blinded independent central review (BICR)-assessed total pathological complete response (tpCR) rate. Results: In total, 908 patients were randomized to the HLX11 (n = 454) or EU-pertuzumab arm (n = 454); 192 patients in HLX11 arm received adjuvant HLX11; 200 patients in EU-pertuzumab arm were re-randomized to receive adjuvant HLX11 (n = 100) or EU-pertuzumab (n = 100). BICR-assessed tpCR rate (95% confidence interval [CI]) was 46.3% (41.6%–51.0%) and 45.8% (41.2%–50.5%), respectively. The equivalence criteria were met, with relative risk of tpCR (90% CI) of 1.01 (0.90–1.14) and relative difference (95% CI) of 0.47% (−5.99%–6.92%). No clinically meaningful differences were observed in other efficacy endpoints, safety, pharmacokinetics (PK), or immunogenicity. In the adjuvant phase, switching from EU-pertuzumab to HLX11 led to no notable differences in safety, PK, or immunogenicity. Conclusions: Compared with EU-pertuzumab, neoadjuvant HLX11 demonstrated a similar tpCR rate and no clinically meaningful differences in other efficacy endpoints, safety, PK, or immunogenicity in BC.

Clinical Cancer Research
Qingdao University (CN), Yuncheng University (CN), University of Science and Technology of China (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Guangxi Medical University (CN), Hefei University of Technology (CN), Bengbu Medical College (CN), Jilin University (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Shantou University (CN), Fuyang City People's Hospital (CN), Mianyang Central Hospital (CN), Sun Yat-sen Memorial Hospital (CN), Shanxi Provincial Cancer Hospital (CN), Zhongshan People's Hospital (CN), Yue Bei People's Hospital (CN), Deyang Stomatological Hospital (CN), Affiliated Hospital of Qingdao University (CN), Neijiang Normal University (CN), Qingdao Municipal Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), First Hospital of Jilin University (CN), Wuhan Union Hospital (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), First Affiliated Hospital of Bengbu Medical College (CN), Chongqing Cancer Hospital (CN), Viva Biotech (China) (CN), Qingdao Center of Resource Chemistry and New Materials (CN), Yueqing People's Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Chongqing Medical University (CN), Guangzhou Medical University (CN)
Good health and well-being
Openalex Percentile: Top 13%
HER2/EGFR in Cancer Research
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