Roche reports data from Phase 3 lidERA Breast Cancer study

Roche (RHHBY) announced “positive” data from the Phase 3 lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm. The iDFS benefit was consistent across all clinically relevant subgroups. Overall survival data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval – another key secondary endpoint. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile. The lidERA results are being presented at the 2025 San Antonio Breast Cancer Symposium and are included in the official press program. “The substantial efficacy observed with giredestrant in the lidERA trial underscores its potential to become a new standard-of-care endocrine therapy in ER-positive early-stage breast cancer, where the chance for cure is highest,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to sharing these results with health authorities around the world with the aim of bringing this new treatment option to patients as soon as possible.”