AstraZeneca's capivasertib shows survival benefit, meets main goals of breast cancer study
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AstraZeneca (NASDAQ:AZN) said its drug capivasertib in combination with Faslodex showed survival benefit in certain patients with breast cancer cancer in a phase 3 trial and become a new option for patients in this setting regardless of biomarker status.
The study called CAPItello-291 enrolled 708 adult patients.
The British pharma giant said on Wednesday that capivasertib in combination with Faslodex (fulvestrant) showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus Faslodex in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or negative locally advanced or metastatic breast cancer, after recurrence or progression on or after endocrine therapy.
PFS is the length of time during/after therapy a patient lives with the disease without it getting worse.
AstraZeneca said that the study trial met both main goals, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.
The company added that data on overall survival (OS), a secondary goal, were immature at the time of analysis but early data was encouraging. The trial will continue to evaluate OS as a key secondary goal.
"These exciting data in an all-comers population indicate that capivasertib could become a new first-in-class treatment option for patients with HR-positive breast cancer," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca.
The safety profile of the combo was similar to that seen in previous trials evaluating this combination, according to the company.