Roche’s oral selective oestrogen receptor degrader (SERD) has reduced the risk of invasive disease recurrence or death by 30% in oestrogen receptor (ER)-positive early-stage breast cancer in a Phase III trial.
In the lidERA Breast Cancer study (NCT04961996), Roche investigated giredestrant as an adjuvant endocrine treatment in patients with ER-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer.
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In interim data, presented at the 2025 San Antonio Breast Cancer Symposium taking place on 9-12 December in San Antonio, Texas, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30%, compared with standard of care (SoC) endocrine therapy.
The invasive disease-free survival (iDFS) benefit was consistent across all clinically relevant subgroups.
After three years of treatment, 92.4% of patients who received giredestrant were alive and free of invasive disease, compared with 89.6% in the SoC cohort.
Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval, meeting another key secondary endpoint.
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By GlobalDataOverall survival (OS) data were immature at the time of analysis, but Roche said that there is a clear positive trend in favour of the study drug.
The drug was well tolerated, with adverse events being manageable and consistent with the known safety profile.
Dr Aditya Bardia, director of the breast oncology program and professor of medicine at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), and principal investigator of the lidERA trial, said: “After almost 25 years, 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.”
This is not the first win for giredestrant in a Phase III trial. In September 2025, Roche subsidiary Genentech said that treatment with giredestrant led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the evERA trial (NCT05306340).
Based on data from the evERA trial, Roche said it would discuss its options with regulators.
If approved, Clinical Trials Arena‘s parent company GlobalData predicts that sales of giredestrant will reach $1.04bn in 2031.
Eli Lilly has also seen success with its oral SERD, imlunestrant, which cut the risk of disease progression or death by 38%; however, only a subset of patients benefited.
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.
Approximately 70% to 80% of all breast cancers are ER-positive, with around a third of patients experiencing recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer.
