Tuesday, AstraZeneca Plc (NASDAQ:AZN) announced topline data from the CAPItello-290 Phase 3 trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC).
The study did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumors harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN).
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TNBC is defined as negative for all three. In the 1st-line setting, approximately 59,000 patients with TNBC are treated with a medicine.
Collectively, mutations in PIK3CA, AKT1, and alterations in PTEN affect approximately 35% of patients with TNBC.
"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 program and across our pipeline," said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca.
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.
Truqap is currently being evaluated in Phase 3 trials for breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.
Last month, AstraZeneca said the survival results did not reach statistical significance in the overall trial population in the TROPION-Lung01 phase 3 trial.
Price Action: AZN shares are down 0.49% at $78.92 during the premarket session at last check Tuesday.
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