Roche presents first phase II data on giredestrant, a next generation selective oestrogen receptor degrader, in untreated oestrogen receptor (ER)-positive, early breast cancer

Basel, 17 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim data from the randomised phase II coopERA Breast Cancer trial evaluating neoadjuvant treatment with giredestrant (formerly known as GDC-9545), an investigational next generation oral selective oestrogen receptor degrader (SERD), in post-menopausal women with ER-positive, HER2-negative early breast cancer. In the window of opportunity phase, after 14 days of treatment, giredestrant showed a reduction in Ki67, a prognostic marker that measures tumour proliferation, compared to anastrozole (80% versus 67% respectively, p=0.0222). The safety profile of giredestrant remained consistent with previous trials and fewer patients experienced side effects assessed as related to giredestrant versus anastrozole.1 Interim analysis results from the coopERA Breast Cancer study will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 and the primary analysis data will be presented at an upcoming medical meeting.“We are pleased to share the first randomised phase II data for giredestrant, which shows encouraging activity and safety in early HR-positive, HER2-negative breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our ongoing co mprehensive programme in HR-positive breast cancer aims to address significant unmet needs for people who still experience a profound impact on their quality of life, including t...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news