8th May 2019 08:17
LONDON (Alliance News) - AstraZeneca PLC on Wednesday said a phase two study of breast cancer drug trastuzumab deruxtecan met its primary endpoint by demonstrating a meaningful response in patients.
The Destiny-Breast01 trial assessed trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer who had failed or discontinued treatment with another drug called trastuzumab emtansine.
In HER2-positive breast cancer, the cancer tests positive for the protein HER2. These types of cancers tend to be more aggressive.
The response rate in the phase two trial of trastuzumab deruxtecan was assessed by an independent review committee. The committee said the response rate confirmed the "unprecedented clinical activity" seen in the phase one trial.
The safety and tolerability profile of trastuzumab deruxtecan was also in line with the phase one trial.
Drug maker Astra said the results of the trial should support its plans for regulatory submissions, including in the US where it will submit a biologics licence application with the Food & Drug Administration in the second half of 2019.
Trastuzumab deruxtecan, which is being jointly developed by Astra and Japanese pharmaceutical firm Daiichi Sankyo Co Ltd, has already obtained FDA breakthrough therapy designation and fast track designation for HER2-positive patients with advanced of refractory breast cancer.
Jose Baselga, AstraZeneca's executive vice president of Research & Development 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 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."
Shares in AstraZeneca were up 0.1% at 5,768.00 pence on Wednesday morning.
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