Positive results from Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan to treat HER2-positive, unresectable breast cancer . Daiichi Sankyo + AstraZeneca

AstraZeneca and Daiichi Sankyo Company, Limited announced positive top-line results for the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201). The HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.

The response rate in DESTINY-Breast01, as assessed by an independent review committee, confirms in a heavily-pretreated, global patient population the unprecedented clinical activity in the recently-published Phase I trial. The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including a Biologics License Application with the Food and Drug Administration (FDA) anticipated in the second half of 2019.

DESTINY-Breast01 is a pivotal Phase II, open-label, global, multicentre, two-part trial of trastuzumab deruxtecan. The optimal dose of 5.4mg/kg was previously identified in part one of the trial. These results from part two evaluated the efficacy and safety of that dose in patients who have failed or discontinued previous treatment with trastuzumab emtansine.

Comment: AstraZeneca and Daiichi said their pivotal Phase II DESTINY-Breast01 trial assessing the HER2-targeting antibody drug conjugate trastuzumab deruxtecan met its primary endpoint, supporting global regulatory submission plans starting in this year�s second half.