Overview
- Topline TROPION‑Breast02 data showed statistically significant, 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 ineligible for PD‑1/PD‑L1 therapy, including PD‑L1–negative tumors and others unable to receive immunotherapy.
- AstraZeneca and Daiichi Sankyo said this is the first trial to demonstrate an overall survival advantage over chemotherapy in this first‑line TNBC population.
- Safety was consistent with prior Datroway studies, and the TROP2‑directed antibody‑drug conjugate already has U.S. approvals in HR‑positive breast cancer and EGFR‑mutated non‑small cell lung cancer.
- Full results will be presented at a medical meeting with submissions to global regulators planned, while shares of both companies rose and Gilead’s Trodelvy remains a competing TROP2 ADC.