Pharma Update
Giredestrant in HR+ breast cancer
Potential new endocrine backbone potential across eBC and mBC
Selective ER degrader (SERD)
ER
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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
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