Health · Medical Research · 12 hrs ago
BioNTech and DualityBio report modest benefit from breast cancer drug
BioNTech and DualityBio tested trastuzumab pamirtecan in people with HER2-low breast cancer, where tumors have low but detectable levels of the HER2 protein.
The antibody-drug conjugate delayed tumor progression in a Phase 3 trial, meeting the study’s main goal, but the improvement was modest.
The treatment was linked to more cases of lung inflammation than the companies had seen in earlier testing; some events were severe or fatal, though they affected a small proportion of patients.
The trial did not run long enough to show a clear survival benefit.
The companies said the drug’s potential benefit may be limited because Enhertu is already an established treatment for HER2-low breast cancer.
BioNTech and DualityBio will discuss the findings and decide what to do next, while the drug remains in two other trials, including one in HER2-positive endometrial cancer.
BioNTech and DualityBio said their antibody-drug conjugate trastuzumab pamirtecan met the main goal in a Phase 3 breast cancer study.
The treatment delayed tumor progression in people with HER2-low breast cancer, but the companies described the benefit as modest.
The companies said the findings suggest the treatment’s potential benefit may be limited in the current treatment landscape.
The trial was not long enough to show a clear survival benefit, and researchers observed higher rates of interstitial lung disease than in earlier testing.
The partners said they would discuss the data and determine next steps.
- Who
- BioNTech and DualityBio.
- What
- They reported modest results for trastuzumab pamirtecan in a Phase 3 study of HER2-low breast cancer and said they would discuss next steps.
- When
- The companies announced the findings on Monday, Oct. 26, 2026.
- Where
- The study involved people with HER2-low breast cancer. A specific location is not stated.
- Why
- The treatment delayed tumor progression, but the benefit was modest, the trial did not show a clear survival benefit, and there were safety concerns.
This story does not have two clearly opposing sides.
BioNTech obtained trastuzumab pamirtecan through a licensing deal with DualityBio.
The companies reported Phase 3 study results showing a modest delay in tumor progression for people with HER2-low breast cancer.
The companies said they would discuss the data and determine next steps.
- Drug
- Trastuzumab pamirtecan
- Study phase
- Phase 3
- Cancer type
- HER2-low breast cancer
- Study outcome
- Delayed tumor progression; improvement described as modest
- Safety finding
- Higher rates of interstitial lung disease than in earlier testing
- Licensing deal
- BioNTech obtained the drug from DualityBio in 2023
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What people are saying
The combined findings “suggest that the potential benefit to patients would be limited
discuss the data and determine next steps