BioNTech flags limited breast-cancer benefit and lung toxicity despite trial success

BioNTech ($BNTX) and DualityBio reported that trastuzumab pamirtecan met the primary endpoint in DYNASTY-Breast02, but described its progression-free survival advantage as modest. The global Phase 3 trial randomized 541 patients with hormone receptor-positive, HER2-low metastatic breast cancer who had progressed after endocrine treatment and had not received chemotherapy for metastatic disease. Overall survival results remained immature, and numerical efficacy estimates were not disclosed.

Interstitial lung disease occurred more frequently than in previous trials of the experimental antibody-drug conjugate. Most cases were mild or moderate, but a small proportion were severe or fatal. The partners said the combined efficacy and safety findings suggested limited benefit in this treatment setting and would determine next steps. The announcement does not report a regulatory filing or a decision to terminate development.

Sources:

• GlobeNewswire