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Roche’s Giredestrant Cuts Early Breast Cancer Recurrence 30% in Phase III Trial

Regulatory filings are planned following the SABCS presentation with overall survival still immature.

Overview

  • The prespecified interim analysis of the global, 4,170‑patient lidERA study met its primary and key secondary endpoints after a median 32.3 months of follow‑up.
  • At three years, invasive disease‑free survival was 92.4% with giredestrant versus 89.6% with standard endocrine therapy.
  • Giredestrant reduced the risk of distant recurrence by about 31%, with benefits reported across key prespecified subgroups.
  • Common low‑grade side effects were similar between arms, though mild, asymptomatic bradycardia was higher with giredestrant (11.3% vs 3.2%) and discontinuations were lower (5.3% vs 8.2%).
  • Investigators and Roche described the oral SERD as a potential new adjuvant standard for HR‑positive, HER2‑negative disease, while OS results and optimal integration with CDK4/6 inhibitors remain open questions.