AstraZeneca, Daiichi Sankyo Tout Benefit of Enhertu in Breast Cancer Study

AstraZeneca (AZ) and Daiichi Sankyo have announced that an interim analysis from a phase 3 trial showed that their antibody drug-conjugate Enhertu (trastuzumab deruxtecan) posted positive progression-free survival relative to trastuzumab emtansine (T-DM1).

Based on yet-undisclosed results, the DESTINY-Breast03 study’s data monitoring committee determined the trial met its primary endpoint, with “highly statistically significant and clinically meaningful improvements” for patients with HER2-positve, unresectable breast tumors that have already been treated with trastuzumab and a taxane, AstraZeneca said.

Enhertu also showed a strong trend toward improved overall survival compared to T-DM1 in a key secondary endpoint, “although the overall survival data are still immature,” the company said.

Enhertu received FDA accelerated approval in late 2019. In January, the drug was approved for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.