Trastuzumab Deruxtecan Approaching Approval for Treatment of HER2+ Breast Cancer

Updated trial results suggest DS-8201 for HER2-positive metastatic breast cancer approaching FDA approval.

by Dr. C.H. Weaver M.D. updated 10/2019

The FDA has granted priority review to [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer. A Lancet Oncology publications of the Phase I dose-expansion results in HER2-positive metastatic breast was reported in May 2019 and additional data will be released at the San Antonio Breast Cancer Symposia in December that was used for the FDA filing.

DS-8201 is a HER2-targeting antibody drug conjugate (ADC) for the treatment of patients with HER2-positive cancer. Its initial application will be for the treatment of locally advanced or metastatic breast cancer patients who have been treated with Herceptin and Perjeta and have disease progression after ado-trastuzumab (T-DM1). (1)

About DS-8201 (trastuzumab deruxtecan)

ADCs are a type of targeted cancer medicine 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. DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor (DXd) payload by a tetrapeptide linker. It is designed to deliver enhanced cell destruction upon release inside the cell and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

About HER2-Positive Breast Cancer

About one in five patients with breast cancer over-express HER2 (make too much of), a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells, which is associated with aggressive disease.(2) Many tumors advance to the point where no currently approved HER2-targeting treatment continues to control the disease. Furthermore, there is no standard of care for HER2-positive tumors following treatment with Herceptin, Perjeta and T-DM1.(3)

The results of the initial breast cancer trial reported that an objective response rate of 60% and a disease control rate of 94% was attained at the recommended expansion dose of of DS-8201.(4) An average 20.7 months median duration of response in HER2-positive metastatic breast cancer patients previously treated with trastuzumab emtansine was reported. Patients enrolled in this part of the trial had a median of seven prior lines of treatment, including trastuzumab and trastuzumab emtansine, and in 86% of cases, pertuzumab.

The phase 2 DESTINY-Breast01clinical trial results will be presented at San Antonio Breast Cancer Symposium in December. The trial included 253 patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with Kadcyla (ado-trastuzumab).

The most common reported side effects include nausea, decreased appetite, vomiting, hair loss, fatigue, anemia, diarrhea and constipation. Cases of drug-related interstitial lung disease and pneumonitis, ihave also been reported.

Breakthrough Therapy designation is designed to expedite the development and review of medicines that may demonstrate substantial benefit over currently available treatments in order to ensure that patients with serious diseases have access to new treatments as soon as possible. Currently, there is no FDA-approved therapy for patients with HER2-positive metastatic breast cancer with disease progression following treatment with other HER2-targeting agents Herceptin, Perjeta and T-DM1.


  1. Doi T, et al. J Clin Oncol. 2017;35(15):108
  2. Tamura, K, et al. Trastuzuamb deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):816-826.
  3. American Cancer Society. Breast Cancer Overview. 2016.
  4. NCCN Guidelines. Breast Cancer. Version 2.2017.

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