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3w ago

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy

The Phase 3 result positions the TROP2‑targeting ADC for regulatory filings, potentially shifting first‑line care for patients who cannot receive immunotherapy.

A sign is pictured during the unveiling of AstraZeneca's new manufacturing facility, to be operational in the coming months with an initial focus on T-cell therapies, in Rockville, Maryland, U.S., May 5, 2025. REUTERS/Jonathan Ernst
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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.