AstraZeneca’s Truqap (capivasertib) in conjunction with Faslodex (fulvestrant) has garnered a recommendation for approval in the European Union (EU) for treating adult patients grappling with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer harboring one or more PIK3CA, AKT1, or PTEN alterations post recurrence or progression following an endocrine-based regimen. This recommendation stems from the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was based on the compelling outcomes from the CAPItello-291 Phase III trial reported in The New England Journal of Medicine.
The trial showcased that Truqap combined with Faslodex slashed the risk of disease progression or death by 50% compared to Faslodex alone in patients with tumors possessing PI3K, AKT, or PTEN alterations. This significant reduction in risk was supported by a hazard ratio of 0.50 and a median progression-free survival (PFS) of 7.3 months versus 3.1 months.
In Europe, breast cancer continues to claim the most lives among cancers, with over 140,000 deaths in 2022 and more than 550,000 new cases diagnosed in the same year. HR-positive breast cancer constitutes the majority, with around 70% of tumors being HR-positive and HER2-low or HER2-negative. Resistance to conventional therapies often develops, necessitating alternative approaches to extend treatment effectiveness.
Mafalda Oliveira, MD, PhD, highlighted the urgent need for enhancing the efficacy of standard endocrine therapies for advanced ER-positive breast cancer patients. Susan Galbraith emphasized the potential of Truqap in reshaping treatment approaches for patients facing disease progression on or resistance to standard endocrine therapies.
The safety profile of Truqap plus Faslodex was consistent with previous trials evaluating this combination. Regulatory submissions are undergoing review in China and other countries, while similar indications for Truqap with Faslodex have already been approved in Japan, the US, and several other nations based on the CAPItello-291 trial results.
AstraZeneca’s comprehensive portfolio and pipeline underscore its commitment to revolutionize breast cancer treatment, with a focus on addressing the diverse tumor biology. The company’s vision extends beyond breast cancer, aiming to redefine cancer care and ultimately eliminate cancer as a cause of death.
