What's Happening?
Genentech, a member of the Roche Group, has announced promising results from its Phase III lidERA Breast Cancer study. The study evaluated the efficacy of giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as an adjuvant
endocrine treatment for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. The interim analysis revealed that giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy. This marks a significant advancement in endocrine therapy, the first in over 20 years, for early-stage ER-positive breast cancer, which accounts for approximately 70% of breast cancer cases. The results were presented at the 2025 San Antonio Breast Cancer Symposium.
Why It's Important?
The findings from the lidERA study are significant as they offer a potential new standard-of-care for patients with early-stage ER-positive breast cancer, a group that often faces challenges with disease recurrence and treatment adherence. The ability of giredestrant to reduce the risk of recurrence and improve invasive disease-free survival could lead to better long-term outcomes for patients. This development is crucial as up to a third of patients experience recurrence on or after adjuvant endocrine therapy, and many discontinue treatment due to safety or tolerability issues. The introduction of a more effective and tolerable treatment option could enhance adherence and reduce the risk of recurrence, ultimately improving survival rates.
What's Next?
Following the positive results of the lidERA trial, Genentech plans to share these findings with health authorities worldwide to expedite the availability of giredestrant as a treatment option. The company is also continuing follow-up for overall survival data, which showed a positive trend, and will conduct further analyses. Genentech's extensive clinical development program for giredestrant includes multiple Phase III trials across various treatment settings, reflecting its commitment to improving outcomes for patients with ER-positive breast cancer.
