Drugs and FDA
BioNTech and DualityBio report modest benefit from breast cancer ADC
The Phase 3 trial found modestly delayed tumor progression in HER2-low breast cancer, without a clear survival benefit.
BioNTech and DualityBio said their antibody-drug conjugate trastuzumab pamirtecan met its main goal in a Phase 3 study of people with breast cancer whose tumors had low but detectable levels of HER2. The treatment delayed tumor progression, but the companies described the improvement as modest.
The companies also reported higher rates of interstitial lung disease than in earlier testing, along with severe and fatal events in a small proportion of patients. They said the trial had not run long enough to show a clear survival benefit, and that the findings suggest the potential benefit for people with HER2-low metastatic breast cancer may be limited. The partners said they will discuss the data and determine next steps.
