Roche’s Genentech has released positive phase 3 results for its oral selective estrogen receptor degrader (SERD), giredestrant, as an adjuvant endocrine treatment for early-stage breast cancer.
Giredestrant is an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. The lidERA Breast Cancer study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy, making giredestrant the first SERD to demonstrate superior invasive disease-free survival in early breast cancer. This suggests that the drug could become the new standard-of-care endocrine therapy for early-stage cases.
According to Roche, at this interim analysis, it is too soon to gain overall survival data, although there is a clear positive trend. The results of the lidERA study followed positive results from the evERA Breast Cancer phase 3 trial.