Global pharma giant Roche has announced the results of its phase III persevERA study evaluating investigational giredestrant combined with palbociclib in people with ER-positive, HER2-negative, locally advanced or metastatic breast cancer.
The trial did not meet its primary objective of a statistically significant improvement in progression-free survival compared with letrozole plus palbociclib. However, Roche noted a numerical improvement and said the adverse events for the giredestrant combination were manageable, consistent with the known safety profiles of the individual drugs.
“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, MD, PhD, 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.”
Roche emphasized that its giredestrant clinical program is tailored to the biology of each breast cancer stage, aiming to identify the patients who could benefit most. Previous trials, including evERA and lidERA, have shown positive results, with the phase II coopERA study demonstrating giredestrant’s superiority over aromatase inhibitors in reducing malignant cell division.
persevERA is the first of two phase III first-line studies, with pionERA, testing giredestrant plus a physician’s choice of CDK4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer, expected to read out in 2027.
Regulatory momentum is building: the US FDA recently accepted the New Drug Application based on evERA data, and Roche plans to submit lidERA phase III results in early-stage breast cancer in the coming weeks.
