AstraZeneca Teams with Daiichi Sankyo to Speed Development of HER2-positive Advanced Breast Cancer Therapy

AstraZeneca Teams with Daiichi Sankyo to Speed Development of HER2-positive Advanced Breast Cancer Therapy
AstraZeneca is starting a collaboration with Daiichi Sankyo for the global production and commercialization of trastuzumab deruxtecan (DS-8201), a novel antibody-drug conjugate under clinical studies for the treatment of advanced HER2-positive breast cancer, and other types of solid tumors. The investigational therapy was granted fast track status by the U.S. Food and Drug Administration (FDA) in 2016, and gained breakthrough therapy designation in 2017, for patients with HER2-positive, locally advanced or metastatic breast cancers that progressed after prior HER2 therapies, including Kadcyla (ado-trastuzumab emtansine). Early results from a pivotal Phase 1 clinical trial (NCT02564900), still  underway, show that treatment with trastuzumab deruxtecan has a "strong activity in a number of tumor types," Astrazeneca stated in a press release. Of note, the magnitude and duration of response was highest in patients with HER2-positive metastatic breast cancer who have progressed after prior treatment with Kadcyla. In these patients, overall response rate was 64.2%, meaning that the tumors shrunk at least partially in 43 of 67 patients. The response lasted a median of 7.6 months. Trastuzumab deruxtecan is an antibody-conjugated drug, composed of an approved anticancer HER2-targeting antibody (trastuzumab, brand name Herceptin) linked to an investigational cancer-killing agent (an exatecan derivative, deruxtecan). The product was designed so that trastuzumab helps deliver deruxtecan specifically to HER2-expressing cancers, improving cancer specificity and reducing off-targets, when compared with conventional chemotherapy. A broad development program is underway in North America, Europe, and Asia, including five pivotal trials in HER2-express
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