Overview

• High-level results from the Phase 3 TROPION-Breast02 trial show statistically significant and clinically meaningful improvements in overall survival and progression-free survival versus investigator’s-choice chemotherapy.
• The study enrolled previously untreated patients with locally recurrent inoperable or metastatic triple-negative breast cancer who were not candidates for immunotherapy, including those with PD-L1–negative tumors.
• The companies reported a safety profile consistent with prior Datroway breast cancer studies.
• AstraZeneca and Daiichi Sankyo said full data will be presented at a medical meeting and submitted to global regulators as soon as possible.
• Company leaders said this is the first trial to demonstrate a survival benefit over chemotherapy in this first-line, immunotherapy-ineligible population, setting up competition with Gilead’s Trodelvy, which had not shown an overall survival benefit to date.