Roche’s Giredestrant Achieves Strong Phase III Results In lidERA Early Breast Cancer Trial

Roche reported positive Phase III outcomes from its lidERA Breast Cancer study, which tested the investigational SERD giredestrant as an adjuvant endocrine therapy for patients with ER-positive, HER2-negative early-stage breast cancer. In a pre-planned interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival compared with standard endocrine therapy. This marks the first time a selective estrogen receptor degrader has shown such benefit in the adjuvant setting, where most breast cancer cases are diagnosed.

“Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Given that ER-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced ER-positive setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease.”

Although overall survival results are still immature, the interim readout showed a favorable trend. Safety outcomes were consistent with the known profile of giredestrant, with no unexpected adverse events. Roche plans to share the full data from lidERA at an upcoming scientific meeting and submit the results to global regulatory agencies, aiming to make this therapy available to early-stage breast cancer patients who need better treatment alternatives.

ER-positive breast cancer represents roughly 70% of cases, with up to one-third of patients experiencing recurrence after current adjuvant endocrine therapies, often due to insufficient efficacy or tolerability issues that force early discontinuation. The lidERA results add to the growing evidence base, including the earlier evERA Phase III study and data from the coopERA neoadjuvant trial, all of which support the potential of giredestrant to outperform existing endocrine therapies across early and advanced disease. Roche continues to advance an extensive development program to bring this innovation to as many patients as possible.