Genentech Provides Update on Phase III persevERA Study in ER-positive Advanced Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today results from the Phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. 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. 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, M.D., Ph.D., 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.”

The giredestrant clinical development program is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer. Genentech will continue to advance the clinical development program to identify the people with ER-positive breast cancer who can derive the greatest benefit from giredestrant.

Giredestrant Phase III clinical development program

Trial	Indication	Regimen
lidERA Breast Cancer	Adjuvant ER+/HER2- breast cancer	Giredestrant vs. standard-of-care endocrine therapy (SoC ET)
persevERA Breast Cancer	1L ER+/HER2- metastatic breast cancer (endocrine-sensitive)	Giredestrant + palbociclib vs. letrozole plus palbociclib
pionERA Breast Cancer	1L ER+/HER2- metastatic breast cancer (endocrine-resistant)