AstraZeneca upbeat on latest results from potential breast cancer drug
AstraZeneca and its partner Daiichi Sankyo Company announced positive top-line results for the pivotal phase 2 ‘DESTINY-Breast01’ trial of trastuzumab deruxtecan (DS-8201) on Wednesday.
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The FTSE 100 pharmaceutical giant said the HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.
It said the response rate in DESTINY-Breast01, as assessed by an independent review committee, confirmed in a “heavily-pretreated, global” patient population the “unprecedented” clinical activity in the recently-published phase 1 trial.
The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience.
AstraZeneca said the results were expected to support planned global regulatory submissions, including a biologics license application with the US Food and Drug Administration (FDA), expected in the second half of 2019.
DESTINY-Breast01 was described by the company as a pivotal phase 2, open-label, global, multicentre, two-part trial of trastuzumab deruxtecan.
The optimal dose of 5.4 milligrams per kilogram of body weight had been previously identified in part one of the trial.
Results from part two, released on Wednesday, evaluated the efficacy and safety of that dose in patients who had failed or discontinued previous treatment with trastuzumab emtansine.
“We are encouraged to see positive data from trastuzumab deruxtecan, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown,” said José Baselga, AstraZeneca executive vice-president of research and development in oncology.
“We believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2-expressing cancers, and 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.”
Antoine Yver, executive vice-president and global head of oncology research and development at Daiichi Sankyo, added that the results confirmed their commitment to pursue accelerated regulatory pathways in HER2-positive metastatic breast cancer with trastuzumab deruxtecan.
“We are more dedicated than ever to our comprehensive and ambitious development strategy evaluating the potential across a spectrum of HER2-expressing cancers including breast, gastric, lung and colorectal.”
Trastuzumab deruxtecan had been granted US FDA ‘Breakthrough Therapy’ and ‘Fast Track’ designation for HER2-positive patients in the advanced or refractory breast cancer setting.
A recent publication in the Lancet Oncology reported long-term phase 1 safety and preliminary efficacy results in HER2-positive metastatic breast cancer.
The potential new medicine was currently in development for the treatment of multiple HER2-expressing cancers, including in patients with HER2-low expression, AstraZeneca explained.
The company and Daiichi Sankyo said they planned to present the data from DESTINY-Breast01 at a forthcoming medical meeting.