Roche’s Giredestrant Achieves Significant Phase III Benefit in Early ER-Positive Breast Cancer; lidERA Trial Shows Giredestrant Reduces Recurrence Risk

Roche announced encouraging phase III results from its lidERA Breast Cancer study, which assessed the investigational oral SERD giredestrant as an adjuvant endocrine therapy for people with ER-positive, HER2-negative early breast cancer. At the planned interim analysis, giredestrant lowered the risk of invasive disease recurrence or death by 30% compared with standard endocrine therapy, achieving statistical significance. After three years, more patients on giredestrant remained alive and free from invasive disease than those receiving standard-of-care treatment.

“In early ER-positive breast cancer, challenges with disease recurrence and treatment adherence mean there is an urgent need for more effective, tolerable endocrine therapies,” said Aditya Bardia, M.D., M.P.H, Director, Breast Oncology Program, Professor of Medicine at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, and lidERA principal investigator. “After almost 25 years, a new medicine –  giredestrant – has demonstrated superiority over existing endocrine therapies in the curative setting, highlighting its potential as a new standard-of-care endocrine therapy for patients with breast cancer.”

The benefit of giredestrant was consistent across all clinically relevant subgroups, and while overall survival data are still immature, an encouraging positive trend has already emerged. The therapy also reduced the risk of distant recurrence by 31%, a key secondary endpoint. Safety outcomes were favorable, with adverse events manageable and aligned with the known profile of the drug.

ER-positive breast cancer represents around 70% of all breast cancer cases, yet recurrence remains a major challenge, with up to one-third of patients experiencing disease return during or after standard endocrine therapy. Tolerability issues often lead patients to discontinue treatment early, further increasing the risk of poor outcomes. These challenges highlight the need for more effective and better-tolerated therapies that can support long-term adherence.

“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.”

Giredestrant is now the first oral SERD to demonstrate a superior invasive disease-free survival benefit in the adjuvant setting. The lidERA results also build on previous positive findings in metastatic and neoadjuvant settings, including the evERA and coopERA studies. Combined, the data strengthen the potential of giredestrant to improve outcomes across multiple stages of ER-positive breast cancer. Roche continues to advance a broad development program to extend the reach of this innovative therapy.