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AstraZeneca’s Combination Therapy Shows Significant Efficacy in Phase III Trial

Cambridge, UK- On Monday, AstraZeneca’s combination of Truqap (capivasertib) with Faslodex (fulvestrant) received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This recommendation pertains to the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, it targets patients with tumors that exhibit one or more alterations in the PIK3CA, AKT1, or PTEN genes following the failure of an initial endocrine-based treatment.

Clinical Trial Success

The positive opinion from CHMP is based on the compelling results of the CAPItello-291 Phase III clinical trial, recently published in The New England Journal of Medicine. The study demonstrated that the combination of Truqap and Faslodex significantly reduced the risk of disease progression or death by 50% compared to the use of Faslodex alone. This was particularly evident in patients whose tumors had alterations in PI3K, AKT, or PTEN. The trial reported a median progression-free survival (PFS) of 7.3 months for the combination therapy, significantly longer than the 3.1 months observed with Faslodex alone. The statistical significance of these findings was underscored by a p-value of less than 0.001.

Impact and Approval Status

Breast cancer continues to be the leading cause of cancer-related deaths among women in Europe, with over 140,000 deaths recorded in 2022 and more than 550,000 new cases diagnosed. The recommendation by CHMP marks a critical step forward in offering a new therapeutic option for patients affected by this challenging disease stage.

Regulatory reviews for Truqap in combination with Faslodex are currently underway in China and several other countries. Notably, this treatment combination has already been approved in Japan, the United States, and several other countries, reflecting its global potential and impact.

This development underscores AstraZeneca’s commitment to advancing cancer treatment and provides hope for patients with limited therapeutic options after the first line of defense fails. As regulatory bodies continue to review the data, the medical community eagerly anticipates the broader availability of this treatment combination, aiming to provide patients with a more effective tool against advanced breast cancer.

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