Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
Safety and Efficacy of KN046 in Combination with KN026 in Patients with Advanced HER2-Positive Breast Cancer: A Phase II Trial.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
4 citing papers in PubMed.
- Longitudinal tissue analysis reveals microenvironmental changes correlate with combined immunotherapy and targeted therapy response in metastatic breast cancer.Journal for immunotherapy of cancer · 2025Trial
- Review
- Anbenitamab: First Approval.Drugs · 2026Article
- Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.International journal of molecular sciences · 2025Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
purposeIn this study, we report the results from a phase II trial assessing the safety and efficacy of KN046 in combination with KN026 in patients with HER2-positive metastatic breast cancer, who had progressed after prior anti-HER2 combination therapies. PATIENTS AND
methodsFemale patients with metastatic HER2-positive breast cancer, who were previously treated with at least one line of HER2-targeted combination therapy, were enrolled from multiple academic hospitals in China to receive KN046 (i.v. 5 mg/kg every 3 weeks) plus KN026 (i.v. 30 mg/kg every 3 weeks) until progression, unacceptable toxicities, or patient withdrawal. Efficacy was evaluated every 6 weeks per RECIST 1.1. The primary endpoint was objective response rate.
resultsA total of 36 patients with the median age of 53 years were enrolled. Of these 36 patients, 30 (83.3%) received ≥3 lines of HER2-targeted combination therapies in the metastatic setting. Thirty-three patients were evaluable for overall response and all 36 for safety. The objective response rate was 47.2% (95% confidence interval, 30.4-64.5), with two patients achieving complete response. The median progression-free survival was 5.6 months (95% confidence interval, 4.1-13.8). Of the 36 patients, 34 (94.4%) experienced treatment-related adverse events (TRAE) of any grade, and 10 of 36 (27.8%) patients had experienced ≥grade 3 TRAEs. The most common TRAEs were infusion-related reaction (36.1%), rash (16.7%), alanine aminotransferase increased (13.9%), diarrhea (13.9%), and pruritus (13.9%). No treatment-related deaths were observed.
conclusionsThe combination of KN046 and KN026, as a chemo-free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pretreated patients with advanced HER2-positive breast cancer.
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