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Pharma Update

Giredestrant in HR+ breast cancer Potential new endocrine backbone potential across eBC and mBC Selective ER degrader (SERD) ER XXIX ER is immobililized, preventing activation of ER target genes ER ER is ubiquitinated & turned over, as a consequence of ER immobilization Broad development program in eBC and mBC Ph III (lidERA) trial design in adjuvant ER+/HER2-BC Clinical development program Giredestrant 30mg QD Screening (n=4,100) R 1:1 Physician's choice of adjuvant endocrine monotherapy Long-term follow-up (5 years) Indication regimen 1L ER+/HER2-mBC giredestrant + palbociclib 1L ER+/HER2- MBC giredestrant + CDK4/6 of choice Phl Ph ll Ph III persevERA pionERA Adjuvant ER+/HER2- BC giredestrant lidERA 1L maintenance ER+/HER2+ mBC giredestrant + Phesgo heredERA • Highest preclinical potency vs. other oral SERDS in development Combinable with all CDKis including: palbociclib, abemaciclib, ribociclib • Well tolerated at all doses, with no dose-limiting toxicity • Girdestrant has the potential to be best-in-class backbone endocrine agent in HR+ BC, either used alone or in combination, replacing standard of care (aromatase inhibitor, fulvestrant or tamoxifen) • A single-arm lidERA substudy will investigate giredestrant + abemaciclib in high risk eBC patients; lidERA is -1 yr ahead of other oral SERD competition in eBC • Initiated additional Ph III (pionERA) trial in 1L mBC (girdestrant + CDK4/6 of choice vs. fulvestrant + CDK4/6 of choice) • First results from Ph III persevERA (1L mBC) expected in 2025 SERD=Selective estrogen receptor degrader; HR-Hormone receptor; ER-Estrogen receptor; HER2-Human epidermal growth factor receptor 2; BC=Breast cancer; mBC=metastatic breast cancer; eBC-early breast cancer; CDKi-Cyclin-dependent Kinase Inhibitor; CDK4/6-CDKI-Cyclin-dependent Kinase 4/6 74 Roche
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