11th Dec 2019 13:41
(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Wednesday reported positive detailed data from the phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan.
Trastuzumab deruxtecan is a potential new medicine for patients with metastatic breast cancer.
The FTSE 100-listed drugmaker said the primary endpoint of objective response rate was 60.9% with trastuzumab deruxtecan monotherapy.
The safety and tolerability profile of trastuzumab deruxtecan in DESTINY-Breast01 was consistent with that observed in the phase I trial, Astra noted.
"These results are particularly striking as trastuzumab deruxtecan prompted a high level of durable tumour reduction among patients, the majority of whom had exhausted most if not all standard therapies for HER2-metastatic breast cancer," said Ian Krop, a principal investigator of the DESTINY-Breast01 trial.
The company said regulatory submission of trastuzumab deruxtecan for the treatment of patients with metastatic breast cancer was recently accepted with priority review by the US Food & Drug Administration. A regulatory submission has also been made to Japan's Ministry of Health, Labour & Welfare.
Astra shares were trading 0.7% higher in London on Wednesday afternoon at 7,298.67 pence each.
By Evelina Grecenko; [email protected]
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