QL1209（曲妥珠单抗生物类似药）对比曲妥珠单抗联合多西他赛与参考用曲妥珠单抗用于人表皮生长因子受体 2 阳性、激素受体阴性、早期或局部晚期乳腺癌新辅助治疗：一项多中心、随机、双盲、平行对照、III 期等效性试验。
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.
机构信息
Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Department of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 233099, China.
出版信息
Br J Cancer. 2024 Sep;131(4):668-675. doi: 10.1038/s41416-024-02751-2. Epub 2024 Jun 21.
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.
背景
这项随机、平行对照、双盲、三期等效性研究评估了一种拟议的曲妥珠单抗生物类似药 QL1209 与曲妥珠单抗联合多西他赛在新辅助治疗中对 HER2 阳性、ER/PR 阴性的早期或局部晚期乳腺癌患者的等效性，该研究中 Pertuzumab（Perjeta®）也包含在内。
方法
符合条件的患者被随机（1:1）分配接受 4 个周期的新辅助 QL1209 或 Pertuzumab 联合曲妥珠单抗和多西他赛治疗，以及辅助治疗。主要终点是总病理完全缓解（tpCR），等效性边界为 0.76 至 1.32。
结果
在入组的 585 名患者中，257 名和 259 名患者分别被分配到 QL1209 和 Pertuzumab 组。QL1209（255 例中的 109 例，42.75%；90%CI 37.65 至 47.84）和 Pertuzumab（259 例中的 117 例，45.17%；90%CI 40.09 至 50.26）组的 tpCR 率相当。tpCR 风险比为 0.95（90%CI，0.80 至 1.11），90%CI 落入预设的等效性边界内。最常见的≥3 级治疗相关不良事件是 QL1209 和 Pertuzumab 组的中性粒细胞计数减少（10.9%比 12.7%）。
结论
QL1209 在新辅助治疗 HER2 阳性、ER/PR 阴性、早期或局部晚期乳腺癌中显示出与参考 Pertuzumab 等效的疗效和可比较的安全性。
试验注册
Chinadrugtrials.org CTR20201073；ClinicalTrials.gov NCT04629846。
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