Giredestrant (Estrogen Receptor Degrader)
Roche HoldingRHHBY
- Indication
- First-Line ER-Positive HER2-Negative Locally Advanced Or Metastatic Breast Cancer
- Stage
- Phase 3
- Event
- Phase 3 Data readout
- Details
May 19, 2026 — F. Hoffmann-La Roche Ltd announced it will present new data on nine approved and investigational oncology medicines across 15+ indications at the 2026 ASCO Annual Meeting (May 29–June 2, Chicago), with emphasis on breast cancer.
Key highlight is giredestrant, an investigational oral selective estrogen receptor degrader (SERD) for ER-positive/HER2-negative breast cancer (~70% of cases). Roche will present: (1) Phase III lidERA results by menopausal status, building on December 2025 data showing a 30% reduction in risk of invasive disease recurrence or death; Roche says lidERA data have been submitted to the FDA. (2) Phase III persevERA primary analysis of first-line giredestrant + palbociclib in locally advanced/metastatic disease; the trial did not meet its primary endpoint but showed a numerical progression-free survival improvement. (3) Phase III evERA post-progression analyses for giredestrant + everolimus after prior CDK4/6 inhibitor; Roche notes FDA acceptance of an NDA based on evERA.
Additional presentations include early Phase Ic expansion data for brain-penetrant HER2 TKI ZN-A-1041 combinations in pre-treated HER2+ metastatic breast cancer, and data on divarasib+pembrolizumab in KRAS G12C+ NSCLC and Lunsumio+Polivy in relapsed/refractory DLBCL. Clinical significance: supports potential new endocrine standard of care and chemotherapy-free combination strategies.
- Source
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Financial Snapshot
Market Cap
$337.5B
Price
$50.22