Roche has released the results of its persevERA breast cancer phase 3 clinical trial, showing that investigational giredestrant with palbociclib did not lead to a statistically-significant improvement in progression-free survival compared to letrozole with palbociclib.
Patients in the clinical trial had estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally-advanced or metastatic breast cancer. Despite the failure to meet the primary objective, the results did show a numerical improvement and the drug was well tolerated, with a safety profile consistent with the individual treatments.
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist, designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown and stopping or slowing down the growth of cancer cells. Roche is also conducting trials of giredestrant to treat other types of ER-positive breast cancer to determine which patients may gain the greatest benefits from the oral drug. The company has already received positive results from the phase 3 evERA trial of second-line, ER-positive, HER2-negative metastatic breast cancer.
“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, Ph.D., 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 program.”