Roche Holding AGPhase III evERA data show giredestrant combo cut progression risk 44% and FDA accepted NDAs for giredestrant in breast cancer

Roche announced that detailed results from the phase III evERA Breast Cancer study, showing investigational giredestrant plus everolimus significantly improved progression-free survival versus standard endocrine therapy plus everolimus, were published in The New England Journal of Medicine. In the ESR1-mutated population, median PFS was 10.0 months with the giredestrant combination compared with 5.5 months in the comparator arm, a stratified hazard ratio of 0.38, while in the intent-to-treat population median PFS was 8.8 months versus 5.5 months, a hazard ratio of 0.56, corresponding to a 44% reduction in the risk of disease progression or death in the ITT population and 62% in the ESR1-mutated population. Overall survival data were immature but showed a clear positive trend in both the ITT population, with a hazard ratio of 0.69, and the ESR1-mutated population, with a hazard ratio of 0.62, and adverse events were manageable with no unexpected safety findings, including no photopsia and low rates of bradycardia. Based on these data, the US Food and Drug Administration accepted Roche's New Drug Application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer, with a decision expected by 18 December 2026, and also accepted a Priority Review NDA for giredestrant as adjuvant treatment in early breast cancer based on the lidERA results, with a Prescription Drug User Fee Act goal date of 30 November 2026. evERA was the first positive phase III readout for giredestrant, followed by the lidERA Breast Cancer study in the early-stage setting, and additional analyses presented at the 2026 American Society of Clinical Oncology Annual Meeting showed the combination prolongs PFS2 and chemotherapy-free survival compared with standard endocrine therapy.
Roche Holding AGPhase III evERA data show giredestrant combo cut progression risk 44% and FDA accepted NDAs for giredestrant in breast cancer
Rogers Corporation