India Pharma Outlook Team | Wednesday, 19 November 2025
Roche revealed favorable phase III outcomes from the lidERA Breast Cancer trial assessing the experimental giredestrant as an adjunctive endocrine therapy for individuals with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer.
The research reached its main goal during a scheduled interim assessment, revealing a statistically significant and clinically relevant enhancement in invasive disease-free survival with giredestrant compared to traditional endocrine treatment.
lidERA marks the inaugural phase III study of a selective estrogen receptor degrader (SERD) to exhibit a notable advantage in the adjuvant context. Most breast cancer instances are identified in the initial stage.
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“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.”
The overall survival results were not yet fully mature at the interim analysis, but the data showed a noticeable favorable trend. Giredestrant demonstrated good tolerability, and the side-effect profile aligned with what is already known, with no new safety concerns identified.
Findings from the lidERA study will be shared at an upcoming scientific meeting and submitted to regulatory authorities to support making this potential therapy available to patients worldwide.
