- persevERA study did not achieve significant progression-free survival improvement.
- Giredestrant plus palbociclib was well tolerated with known safety profiles.
- FDA accepted New Drug Application based on evERA data.
- pionERA study results expected in 2027.
Study Results
The Phase III persevERA Breast Cancer study evaluated giredestrant combined with palbociclib for ER-positive, HER2-negative advanced breast cancer. It did not meet the primary objective of statistically significant improvement in progression-free survival compared to letrozole plus palbociclib, though a numerical improvement was noted.
Safety Profile
The combination of giredestrant and palbociclib was well tolerated, with adverse events aligning with the known safety profiles of each treatment.
Regulatory Developments
The FDA has accepted the New Drug Application based on evERA data, and Phase III lidERA data will be submitted soon.
Future Research
Genentech plans further studies combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting. The pionERA study, involving giredestrant with a physician’s choice of CDK4/6 inhibitor for endocrine-resistant ER-positive breast cancer, is expected to report results in 2027.
