The double-blinded and randomised trial enrolled 708 patients. Credit: National Cancer Institute on Unsplash.

AstraZeneca has received approval for Truqap (capivasertib) in combination with Faslodex (fulvestrant) in the European Union (EU) for the treatment of certain advanced breast cancer cases in adults.

This marks a significant development for patients with oestrogen receptor (ER)-positive, HER2-negative breast cancer, who have experienced disease progression after endocrine-based therapy.

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The European Commission’s decision follows a favourable recommendation from the Committee for Medicinal Products for Human Use (CHMP).

It is underpinned by results from the Phase III CAPItello-291 trial, which demonstrated a 50% reduction in the risk of disease progression or death when Truqap was used in combination with Faslodex, compared to Faslodex with placebo.

The double-blinded and randomised trial, which enrolled 708 patients, showcased a median progression-free survival of 7.3 months for the combination therapy versus 3.1 months for the placebo group. The safety profile observed was consistent with previous studies of the combination.

It focused on the efficacy of Truqap in conjunction with Faslodex against a placebo plus Faslodex regimen.

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The trial targeted a specific patient group: those with locally advanced or metastatic HR-positive, HER2-low or negative breast cancer, which had recurred or progressed post-aromatase inhibitor treatment.

AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumours harbouring these specific biomarkers.

“Breast cancer continues to be the leading cause of cancer-related death in Europe, and today’s news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.”

With the approval, AstraZeneca’s partner, Astex Therapeutics, stands to receive milestone payments upon the first commercial sale in the EU, and royalties on future sales.

Regulatory reviews of Truqap and Faslodex are ongoing in China, with the combination already approved in the US, Japan and other regions based on the evidence from the CAPItello-291 trial.

In June 2024 the CHMP recommended the approval of AstraZeneca‘s Tagrisso, in combination with chemotherapy, for the first-line treatment of adults with non-small cell lung cancer.