Roche has reported encouraging outcomes from its Phase III lidERA Breast Cancer trial of oral giredestrant as an adjuvant endocrine therapy.
This therapy is intended for those with oestrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer.
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The multicentre, open-label, randomised trial enrolled more than 4,100 subjects and assessed the safety and efficacy of the therapy against a standard-of-care endocrine treatment for individuals with medium-risk or high-risk stage I-III breast cancer.
Its main endpoint is invasive disease-free survival (iDFS), which does not take into account unrelated cancers in organs other than the breast.
Important secondary measures include iDFS that includes second primary non-breast cancers, disease-free survival, overall survival (OS) and safety.
The trial achieved its primary goal at a pre-planned interim analysis, demonstrating an improvement in invasive disease-free survival for those receiving the oral therapy compared to standard-of-care endocrine therapies.
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By GlobalDataAt the interim analysis, OS data is said to have remained immature but showed a clear positive trend.
The safety profile was in line with previous findings for the therapy, without any unexpected safety findings noted.
Giredestrant is a selective oestrogen receptor degrader and full antagonist.
Roche global product development head and chief medical officer Levi Garraway said: “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.
“Given that oestrogen receptor-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced oestrogen receptor-positive setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease.”
lidERA marks the second instance of a positive Phase III readout for giredestrant, after the evERA Breast Cancer trial.
The scientific basis for lidERA was supported by earlier neoadjuvant studies, such as the coopERA trial, which demonstrated that giredestrant led to greater reductions in malignant cell proliferation compared to an aromatase inhibitor.
