Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers November 19, 2017
Pharmacy Choice - Pharmaceutical News - Daiichi Sankyo Initiates Pivotal Phase 2 Study of DS-8201 in Patients with HER2-Positive Metastatic Breast Cancer - November 19, 2017

Pharmacy News Article

 9/14/17 - Daiichi Sankyo Initiates Pivotal Phase 2 Study of DS-8201 in Patients with HER2-Positive Metastatic Breast Cancer

By a News Reporter-Staff News Editor at Women's Health Weekly Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced the initiation of DESTINY-Breast01, a pivotal phase 2 study evaluating the safety and efficacy of investigational HER2-targeting antibody drug conjugate (ADC) DS-8201 in patients with HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to ado-trastuzumab emtansine (T-DM1) (see also Pharmaceutical Companies).

About one in five patients with breast cancer overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells, which is associated with aggressive disease.1 Many tumors advance to the point where no currently approved HER2-targeting treatment continues to control the disease. Furthermore, there is no current standard of care for HER2-positive tumors after treatment with trastuzumab, pertuzumab and T-DM1.2

"The initiation of this phase 2 study represents an important next step to rapidly advance the development of DS-8201, as we will obtain a better understanding of how the smart delivery of chemotherapy directly to targeted cancer cells may help patients with HER2-expressing metastatic breast cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "In addition to this pivotal study, we will continue to evaluate DS-8201 in other HER2-expressing cancers as well as in combination with other therapies where science suggests that it may help improve patient outcomes."

DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part study evaluating the safety and efficacy of DS-8201 in patients with HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to 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 will include a pharmacokinetic stage and a dose finding stage to identify the recommended dose of DS-8201 to be evaluated in the second part of the study. The second part of the study will enroll 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). DESTINY-Breast01 is expected to enroll more than 230 patients at up to 90 sites in North America, Europe, Japan and other countries in Asia. For more information about this clinical trial, please visit ClinicalTrials.gov.

Keywords for this news article include: Pharmaceutical Companies, Oncology, Breast Cancer, Women's Health, Daiichi Sankyo Company Limited.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



(c) 2017 NewsRx LLC

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Nov 20: Obesity Management: Overview of Pharmacotherapy
Last Chance
Nov 21: Standards of Practice for Filling Controlled Substance Prescriptions in Florida
Nov 22: Medical Marijuana: Examining the Science, Not the Politics
Nov 27: Drug Diversion and the Law: Updates and Considerations
Nov 28: An Integrative Approach to Managing Arthritis
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415