AstraZeneca reports CAPItello-290 Phase 3 trial did not meet primary endpoints

The CAPItello-290 Phase 3 trial for Truqap in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer, or TNBC, did not meet the dual primary endpoints of improvement in overall survival, or OS, versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumours harbouring specific biomarker alterations, AstraZeneca announced. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “We are committed to advancing science for patients in some of the most challenging cancers, including this heterogeneous subtype of breast cancer. While we are disappointed in the CAPItello-290 outcome, these results will further our understanding of the role of the PI3K/AKT pathway in breast cancer as we continue our clinical research across the Truqap clinical development programme and across our pipeline.” The company added: “The safety profile of Truqap in combination with paclitaxel in CAPItello-290 was broadly consistent with the known safety profile of each medicine with no new safety concerns identified. Data will be shared in due course. Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.”