Roche has announced that its Phase III persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed. 

The trial assessed giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.   

The company also reported that the adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment. 

“While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.  

“We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies. The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development programme.” 

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown and stopping or slowing down the growth of cancer cells. It is being investigated in five company-sponsored Phase III clinical trials. 

The FDA recently accepted the New Drug Application based on evERA trial data, Roche says data from the Phase III lidERA trial will be submitted to the FDA in the coming weeks. 

persevERA is the first of two Phase III studies in the first-line setting. The pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to readout in 2027.