AstraZeneca’s Truqap Combo Fails to Improve Survival in Phase III Triple-Negative Breast Cancer Trial

1. Trial Failure: AstraZeneca's Truqap (capivasertib) in combination with paclitaxel failed to meet its primary endpoints of improving overall survival in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) in the Phase III CAPItello-290 trial.
2. Dual Primary Endpoints: The trial did not show significant improvement in overall survival in either the overall trial population or in a subgroup of patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN).
3. Safety Profile: The safety profile of Truqap in combination with paclitaxel was consistent with the known safety profile of each medicine.
4. Background: TNBC is a challenging form of breast cancer, accounting for approximately 15% of all breast cancer diagnoses, and is characterized by the lack of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2).
5. Ongoing Trials: AstraZeneca has other ongoing Phase III trials for Truqap, including CAPItello-292 in breast cancer and CAPItello-280 and CAPItello-281 in prostate cancer.
6. Previous Approvals: Truqap was approved by the US FDA in 2023 for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer with AKT pathway mutations, and was recommended for approval in Europe in April 2024.