Roche releases new update on phase 3 persevERA study in ER-positive advanced breast cancer

Roche has recently announced their new results from the phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor positive, human epidermal growth factor receptor 2 -negative, locally advanced or metastatic breast cancer. However, the study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.

“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.”

In addition, 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 phase III clinical development programme

Trial	Indication	Regimen
lidERA Breast Cancer	Adjuvant ER+/HER2- breast cancer	Giredestrant vs. standard-of-care endocrine therapy
persevERA Breast Cancer	1L ER+/HER2- metastatic breast cancer	Giredestrant + palbociclib vs. letrozole plus palbociclib
pionERA Breast Cancer	1L ER+/HER2- metastatic breast cancer	Giredestrant + physician’s choice of CDK4/6 inhibitor vs. fulvestrant + physician’s choice of CDK4/6 inhibitor
evERA Breast Cancer	2L+ ER+/HER2- metastatic breast cancer	Giredestrant + everolimus vs. SoC ET + everolimus
heredERA Breast Cancer	1L maintenance ER+/HER2+ metastatic breast cancer	Giredestrant + Phesgo vs. Phesgo

Note that evERA was the first positive phase III readout for giredestrant, followed by lidERA in the early-stage setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the phase II coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division.

 

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Related Topics and Keywords

breast cancer, ER-positive advanced breast cancer, phase III persevERA study, Roche