Half-Year 2022 Financial and Clinical Trials Update
Giredestrant (SERD (3), RG6171, GDC-9545)
A selective estrogen receptor degrader or downregulator
Indication
ER+ HER2-neg metastatic breast cancer (mBC)
ER+ HER2-neg Stage I-III operable breast
cancer (BC)
Neoadjuvant ER+ breast cancer (BC)
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase I
Phase I
N=181
■ Dose escalation and expansion at RPTD
■ Giredestrant monotherapy and in combination
with palbociclib and/or LHRH agonist
N=75
■ Open-label, pre-operative administration
Dose escalation
■ Safety
"
■ Safety, tolerability and PK/PD
FPI Q4 2017
FPI Q3 2019
☐
Data presented at SABCS 2019, ASCO 2020,
ASCO 2021 and SABCS 2021
☐
Data presented at ASCO 2021
NCT03332797
NCT03916744
Roche
Phase II
coopERA Breast Cancer
N=221
ARM A: Giredestrant followed by giredestrant
plus palbociclib
.
• ARM B: Anastrazole followed by anastrazole
plus palbociclib
■ Safety, tolerability and PK/PD
FPI Q3 2020
Data presented at ESMO and SABCS 2021; ASCO
2022
NCT04436744
ER-Estrogen receptor; HER2-Human Epidermal growth factor Receptor; RPTD=Recommended phase II dose; LHRH=Luteinizing hormone-releasing hormone; PK/PD-Pharmacokinetics/Pharmacodynamics; SABCS=San Antonio
Breast Cancer Symposium; ASCO-American Society of Clinical Oncology
135
OncologyView entire presentation