23rd Sep 2024 08:44
(Alliance News) - AstraZeneca PLC on Monday said a breast cancer drug failed to significantly extend patients' lives, a second blow this month to hopes for the product.
Datopotamab deruxtecan, also known as Dato-DXd, is a targeted chemotherapy known as an antibody drug conjugate, developed with Japanese company Daiichi Sankyo Co Ltd.
In a statement, AstraZeneca, the Cambridge-based pharmaceuticals company, said high-level results from the tropion-breast01 phase III trial of datopotamab deruxtecan did not achieve statistical significance in the final overall survival analysis in patients with inoperable or metastatic hormone receptor-positive, HER2-low or negative breast cancer that had been treated with hormonal therapies.
The safety profile of datopotamab deruxtecan was consistent with that observed in previous trials including lower rates of grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said there is evidence of the clinical "value" of datopotamab deruxtecan, and the pharmaceutical firm will continue discussions with regulatory authorities.
Earlier in September, the drug failed to deliver overall survival benefits in patients with non small cell lung cancer.
More positively, Astra on Monday said that benralizumab, whose brand name is Fasenra, has been recommended for approval in the EU.
It has been recommended as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis, by the European Medicines Agency's Committee for Medicinal Products for Human Use.
CHMP based its positive opinion on results from the Mandara phase 3 trial in which "nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients" while "41% of Fasenra-treated patients fully tapered off oral corticosteroids".
EPGA is a rare, immune-mediated vasculitis that can result in damage to multiple organs. Without treatment, the condition can be fatal.
Shares in AstraZeneca slipped 0.6% to 11,710.00 pence in London on Monday morning. Daiichi Sankyo closed down 0.1% at JPY4,944 in Tokyo.
By Jeremy Cutler, Alliance News reporter
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