AZ, Daiichi planning global submissions for breast cancer ADC

After AstraZeneca paid Daiichi $1.35 billion up front to jointly develop and commercialize the Japanese pharma’s trastuzumab deruxtecan (DS-8201), the partners reported Wednesday that the antibody-drug conjugate met the primary endpoint in the pivotal Phase II DESTINY-Breast01 trial to treat breast cancer. The companies said the data support planned global regulatory applications, including a BLA to FDA next half, for the ADC comprising a humanized anti-HER2 antibody linked to a TOP1 inhibitor.

The two-part, open-label, international trial enrolled 253 patients with HER2-positive unresectable and/or metastatic breast cancer who were previously treated with Kadcyla trastuzumab emtansine...