Update on SERENA-4 Phase III trial

2026-09-14SEC Filing 6-K (0001654954-26-008323)

The SERENA-4 Phase III trial for AstraZeneca's Etcamah in combination with palbociclib did not meet its primary endpoint of statistically significant improvement in progression-free survival (PFS), although a numerical improvement was observed. The trial evaluated this combination against an aromatase inhibitor plus palbociclib in previously untreated patients with advanced ER-positive, HER2-negative breast cancer. While the primary endpoint was not met, Etcamah demonstrated a numerical improvement in PFS and its safety profile was consistent with known data. Etcamah is already approved for a specific patient population based on the SERENA-6 trial, and AstraZeneca remains confident in its potential, especially in combination therapies and for early breast cancer treatment. Further data from SERENA-4 will be shared, and Etcamah continues to be evaluated in comprehensive development programs for various breast cancer settings.

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