BioNTech and partner DualityBio said their antibody-drug conjugate trastuzumab pamirtecan met its primary endpoint in a global Phase 3 trial in patients with HR+/HER2-low metastatic breast cancer. The drug delivered a statistically significant but modest improvement in progression-free survival compared with chemotherapy.
The trial showed a higher rate of interstitial lung disease than prior trials, including some severe and fatal cases.
The companies said the “potential benefit to patients would be limited in the context of the... treatment landscape.” They will discuss the data to determine next steps for the drug.