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
© 2024. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
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| Enthalten in: |
Nature communications - 15(2024), 1 vom: 03. Feb., Seite 1015 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li, Qiao [VerfasserIn] |
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| Links: |
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| Themen: |
130-nm albumin-bound paclitaxel |
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| Anmerkungen: |
Date Completed 07.02.2024 Date Revised 07.02.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1038/s41467-024-45160-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367996707 |
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| 245 | 1 | 4 | |a The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer |b a multicenter phase II trial |
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| 520 | |a 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 | ||
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| 700 | 1 | |a Zhang, Qingyuan |e verfasserin |4 aut | |
| 700 | 1 | |a Ouyang, Quchang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Qiang |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Tao |e verfasserin |4 aut | |
| 700 | 1 | |a Ye, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Baochun |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Summer |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Bangyong |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Binghe |e verfasserin |4 aut | |
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