AstraZeneca breast cancer drug trial fails to improve overall survival

(Sharecast News) - AstraZeneca updated the market on two ongoing drug trials on Monday, with a key trial in breast cancer failing to improve survival. The FTSE 100 pharmaceutical giant said the TROPION-Breast01 phase three trial investigating datopotamab deruxtecan (Dato-DXd) in patients with metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer, being conducted with Daiichi Sankyo, did not show a statistically significant improvement in overall survival (OS) compared to chemotherapy.

Despite that, the trial had previously met its primary endpoint of progression-free survival (PFS), demonstrating a meaningful improvement over chemotherapy.

The company said the safety profile remained consistent, with no new safety concerns reported. Researchers suggest that the approval of other antibody drug conjugates (ADCs) during the trial may have influenced the final survival outcomes.

"The metastatic HR-positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients," said executive vice-president of oncology research and development Susan Galbraith.

"Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting.

"We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for datopotamab deruxtecan in breast cancer."

In a separate development, AstraZeneca's 'Fasenra', or benralizumab, received a recommendation for approval in the European Union as an add-on treatment for eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal condition.

The recommendation by the Committee for Medicinal Products for Human Use (CHMP) was based on results from the MANDARA phase three trial, which showed that nearly 60% of patients treated with Fasenra achieved remission.

Additionally, 41% of Fasenra-treated patients were able to discontinue oral corticosteroids completely, compared to 26% in the comparator arm treated with mepolizumab.

"With today's recommendation, the EGPA community in Europe is one step closer to accessing a new and convenient treatment option to alleviate some of the impact of this debilitating disease," said executive vice-president of biopharmaceuticals, Ruud Dobber.

"With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma, and now has the potential to transform care for patients with EGPA.

"Today's news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma."

At 0829 BST, shares in AstraZeneca were down 0.53% at 11,718p.

Reporting by Josh White for Sharecast.com.