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FDA Approves AstraZeneca's Truqap in HR-Positive, HER2-Negative Breast Cancer

NEW YORK – AstraZeneca on Thursday said the US Food and Drug Administration approved its AKT1/2/3 inhibitor Truqap (capivasertib) as a treatment for patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancers bearing alterations in PIK3CA, AKT1, or PTEN.

Concurrently, the FDA approved the FoundationOneCDx assay as a companion diagnostic to identify breast cancer patients who can benefit from a combination treatment of Truqap and fulvestrant.

The agency's decision was based on results from the Phase III CAPItello-291 trial in which treatment with Truqap and fulvestrant reduced the risk of disease progression or death by 50 percent compared to fulvestrant alone in 289 patients with PIK3CA/AKT1/PTEN-altered tumors. Median overall progression-free survival was 7.3 months for patients on Truqap-fulvestrant versus 3.1 months for those on fulvestrant alone. The hazard ratio for this group was 0.50. To be eligible for the trial, patients must have progressed on at least one endocrine-based regimen in the metastatic setting or had recurrence of their cancer within 12 months of completing adjuvant treatment.

In an exploratory analysis in the 313 patients in the trial whose tumors did not have a PIK3CA/AKT1/PTEN alteration, the hazard ratio was 0.79, showing that the positive results from the trial were attributable to the patients with those alterations.

"Patients with advanced HR-positive breast cancer typically experience tumor progression or resistance with widely used first-line endocrine therapies and there is an urgent need to extend the effectiveness of these approaches," Komal Jhaveri, a medical oncologist at Memorial Sloan Kettering Cancer Center, said in a statement. "The combination of [Truqap] and fulvestrant, a first-of-its-kind combination, provides a much-needed new treatment option for up to half of patients in this setting with these specific biomarkers."