logo
Plus   Neg
Share
Email

AstraZeneca, Daiichi Sankyo: Phase II DESTINY-Breast01 Trial Met Primary Goal

British drug major AstraZeneca Plc (AZN.L,AZN) and Daiichi Sankyo Co. Ltd. (DSKYF.PK) on Wednesday announced that the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201) met primary endpoint.

DESTINY-Breast01 is a pivotal Phase II, open-label, global, multicentre, two-part trial of trastuzumab deruxtecan. The HER2-targeting antibody drug conjugate or ADC and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.

The companies expect the positive top-line results to support planned global regulatory submissions, including a Biologics License Application with the US Food and Drug Administration or FDA, anticipated in the second half of 2019.

Trastuzumab deruxtecan has been granted US FDA Breakthrough Therapy Designation and Fast Track Designation for HER2-positive patients in the advanced or refractory breast cancer setting.

José Baselga, Executive Vice President, R&D Oncology, said, "We are encouraged to see positive data from trastuzumab deruxtecan, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown. …. we are eager to bring it as quickly as possible to patients with refractory HER2-positive breast cancer who continue to have high unmet medical need."

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Elon Musk, the founder and CEO of Space Exploration Technologies, or SpaceX, said the aerospace company is planning to list its space internet venture, Starlink, after many years when revenue growth is smooth and predictable. In a tweet, Musk said, "We will probably IPO Starlink, but only several years in the future when revenue growth is smooth & predictable. Public market does *not* like erratic It's again that day of the year when coffee lovers celebrate their passion for the caffeinated beverage. It is National Coffee Day today in the U.S. when major food and beverage outlets nationwide promote the coffee culture with deals for coffee fans. In the U.S., major coffee outlets such as Starbucks, Dunkin' Donuts, Wawa, Krispy Kreme, Wendy's and Panera Bread give away free cups of coffee. The state of Ohio ordered General Motors to repay $28 million in tax credits after closing the Lordstown plant, which was in agreement to be operated until 2040. The Ohio Tax Credit Authority said the closure violated the terms of two economic development agreements signed by the company. In separate development, GM announced it is investing $71 million in two other Ohio manufacturing facilities.
Follow RTT