The Roche Group announced on 9 March that one of five trials of a Phase 3 development programme for giredestrant, a small molecule drug for breast cancer, failed to demonstrate progression-free survival. The Phase 3 trial, persevERA, was being conducted globally in 992 patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Giredestrant was being tested as a first-line therapy in combination with palbociclip (Ibrance), an approved cyclin-dependent kinase (CDK) 4/6 inhibitor.
In the announcement, Roche expressed confidence that the drug is still poised to set a new standard in the treatment of breast cancer. “We believe there is a path forward by combining giredestrant with a CDK 4/6 inhibitor in the adjuvant setting and we are conducting further studies,” said Levi Garraway, the company’s chief medical officer.
Among the five studies in the Phase 3 programme, two have produced positive data. Roche has already submitted data from the first of these studies, evERA, to the US Food and Drug Administration for review. The application, which was based on a combination study of giredestrant with everolimus (Afinitor) was accepted. Plans are underway to submit data to the FDA from a second study of giredestrant as an adjuvant treatment compared with standard-of-care endocrine therapy in the coming weeks, the company said.
The giredestrant clinical development programme is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer. Giredestrant is an oestrogen receptor degrader and antagonist. It is designed to block oestrogen from binding to the oestrogen receptor, triggering a breakdown, and stopping or slowing the growth of cancer cells.
Copyright 2026 Evernow Publishing Ltd