Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1 - Seite 2

About DESTINY-Breast01
DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part study evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with T-DM1. The primary endpoint of the study is objective response rate. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. The first part of the study includes a pharmacokinetic stage and a dose-finding stage to identify the recommended dose of [fam-] trastuzumab deruxtecan to be evaluated in the second part of the study. The second part of the study enrolled patients into one of two cohorts: patients resistant or refractory to T-DM1 (part 2a) and patients who discontinued treatment with T-DM1 for reasons other than resistant or refractory disease (part 2b).

Enrollment into DESTINY-Breast01 was completed in September 2018, with approximately 230 patients at more than 100 sites in North America, Europe, Japan and other countries in Asia. For more information about this study, visit ClinicalTrials.gov.

Unmet Need in HER2 Positive Breast Cancer
Breast cancer is the most common cancer and the most common cause of cancer mortality in women worldwide; there were an estimated 2.1 million new cases of female breast cancer diagnosed in 2018.¹ Approximately one in five breast cancers (20 percent) are HER2 positive (IHC3+ or IHC2+/ISH+).^2,3 HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells that is associated with aggressive disease and poorer prognosis.^4,5 To be considered HER2 positive, tumor cancer cells are usually tested first by immunohistochemistry (IHC) and reported as: 0, IHC 1+, IHC 2+ or IHC 3+. A finding of IHC 3+ is considered HER2 positive, and a finding of IHC 2+ is borderline and typically is confirmed by a positive fluorescent in situ hybridization (FISH) test.^3,4

Several unmet treatment needs remain today in HER2 positive metastatic breast cancer. Many HER2 positive breast cancers eventually advance to the point where no currently approved HER2 targeting therapy continues to control the disease, and there is no established standard of care after treatment with trastuzumab, pertuzumab and T-DM1.⁶

About [Fam-] Trastuzumab Deruxtecan
[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo's proprietary DXd ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.