The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial

Qiao Li, Jiaxuan Liu, Qingyuan Zhang, Quchang Ouyang, Yang Zhang, Qiang Liu, Tao Sun, Feng Ye, Baochun Zhang, Summer Xia, Bangyong Zhang and Binghe Xu ()
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Qiao Li: Chinese Academy of Medical Sciences and Peking Union Medical College
Jiaxuan Liu: Chinese Academy of Medical Sciences and Peking Union Medical College
Qingyuan Zhang: Harbin Medical University Cancer Hospital/Oncology Department
Quchang Ouyang: Hunan Cancer Hospital
Yang Zhang: Liaocheng People’s Hospital
Qiang Liu: Sun Yat-Sen University
Tao Sun: Cancer Hospital of China Medical University
Feng Ye: Xiamen University, Xiamen
Baochun Zhang: Nantong Tumor Hospital
Summer Xia: Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Bangyong Zhang: Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Binghe Xu: Chinese Academy of Medical Sciences and Peking Union Medical College

Nature Communications, 2024, vol. 15, issue 1, 1-9

Abstract: Abstract This multicenter, phase II study (NCT03872791) aims to evaluate the efficacy and safety of the anti-PD-L1/CTLA-4 bispecific antibody KN046 combined with nab-paclitaxel in the first-line treatment of patients with metastatic triple-negative breast cancer (TNBC). The primary endpoints included objective response rate (ORR) and duration of response (DoR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) rate, safety, and the correlation of PD-L1 status with clinical efficacy. This trial met pre-specified endpoints. 27 female patients were enrolled sequentially to receive KN046 in two dose levels (3 mg/kg or 5 mg/kg). Among the 25 evaluable patients, the ORR achieved 44.0% (95% CI, 24.4% − 65.1%), and the median DoR was not mature. The median PFS reached 7.33 months (95%CI, 3.68 − 11.07 months), and the median OS was 30.92 months (95%CI, 14.75 - NE months). In PD-L1 positive patients, PFS was 8.61 months (versus 4.73 months) and the 2-year OS rate was 62.5% (versus 57.1%) compared to PD-L1 negative patients. Patients tolerated well the combination therapy. In general, KN046 combined with nab-paclitaxel showed favorable efficacy and survival benefits with tolerable toxicity in the first-line treatment of metastatic TNBC, especially PD-L1 positive, which is worth further investigation.

Date: 2024
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DOI: 10.1038/s41467-024-45160-y

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