AstraZeneca's CAPItello-290 Trial for Advanced TNBC Fails Primary Endpoints

AstraZeneca announced that its Phase III CAPItello-290 clinical trial, investigating the efficacy of Truqap (capivasertib) in combination with paclitaxel for patients with advanced or metastatic triple-negative breast cancer (TNBC), did not meet its dual primary endpoints. The trial failed to demonstrate a statistically significant improvement in overall survival (OS) compared to paclitaxel combined with placebo, both in the overall patient population and in a subgroup with tumors harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN).

Triple-negative breast cancer, accounting for approximately 15-20% of all breast cancers, remains a challenging subtype to treat due to a lack of targeted therapies, with chemotherapy continuing as the mainstay of treatment. Biomarker alterations in PIK3CA, AKT1, or PTEN are present in about 35% of TNBC patients, representing potential targets for drug development.

“While the CAPItello-290 trial results have not shown what we hoped, they provide important information to further understand this aggressive form of breast cancer where patients are in urgent need of new treatments,” said Peter Schmid, MD, Barts Cancer Institute, London, and principal investigator for the trial. He highlighted the ongoing need for novel therapeutic options for patients facing limited choices.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, acknowledged the disappointment with the outcome. She stated that the findings will further the understanding of the PI3K/AKT pathway's role in breast cancer as the company continues its clinical research across the Truqap development program and its pipeline.