Roche breast cancer pill cuts post-surgery recurrence risk by 30% in major trial
Roche’s experimental oral drug giredestrant reduced the risk of breast cancer recurrence by 30% compared with standard adjuvant endocrine therapy in a phase III trial.1
The data come from the large phase III lidERA trial in patients with estrogen receptor (ER)-positive early breast cancer, the most common subtype of the disease.12
At three years, 92.4% of patients receiving giredestrant were alive and disease‑free versus 89.6% in the standard-of-care endocrine therapy arm.1
Roche described this as the first major advance in hormonal (endocrine) treatment for early breast cancer in over 20 years, as giredestrant outperformed long‑standing standard therapies.12
The drug is an oral selective estrogen receptor degrader (SERD), designed to more effectively block and degrade the estrogen receptor that drives tumor growth in ER‑positive cancers.12
Roche’s chief medical officer explained that a 30% improvement in disease‑free survival means about 30% fewer patients experience recurrence compared with standard therapy.1
ER‑positive breast cancer accounts for about 70% of all breast cancer cases, and up to one-third of patients with early-stage disease eventually recur despite current treatments, highlighting a major unmet need.12
Giredestrant showed a favorable safety profile, with numerically fewer treatment discontinuations due to side effects than standard endocrine therapy in the trial.1
The results position giredestrant as a potential new standard of care in adjuvant endocrine therapy after surgery, although it remains to be clarified which patients will still need additional drugs such as CDK4/6 inhibitors (e.g., Novartis’ Kisqali).1
Analysts have estimated that if approved for adjuvant use, giredestrant could reach around $5 billion in annual sales, reflecting the large ER‑positive early breast cancer population.1
Detailed results are being presented at the San Antonio Breast Cancer Symposium, a major international breast cancer meeting, underscoring the scientific and clinical importance of the findings.1
Sources:
1. https://whbl.com/2025/12/10/roche-breast-cancer-pill-cuts-risk-of-disease-recurrence-by-30-in-trial/
2. https://newsroom.ucla.edu/releases/novel-breast-cancer-therapy-reduces-recurrence-risk-hr-positive-HER2-negative-ucla