Roche Pharmaceutical Development and Sales Overview
Giredestrant (SERD (3), RG6171, GDC-9545)
A selective estrogen receptor degrader or downregulator
Indication
Phase/study
# of patients
Design
ER+ HER2-neg metastatic breast cancer (mBC)
ER+ HER2-neg Stage I-III operable breast
cancer (BC)
Phase I
N=181
Dose escalation and expansion at RPTD
☐
Giredestrant monotherapy and in combination with
palbociclib and/or LHRH agonist
Neoadjuvant ER+ breast cancer (BC)
Phase I
N=75
Open-label, pre-operative administration
Dose escalation
Phase II
coopERA Breast Cancer
N=221
ARM A: Giredestrant followed by
giredestrant plus palbociclib
ARM B: Anastrazole followed by
anastrazole plus palbociclib
Primary endpoint
Safety
Safety, tolerability and PK/PD
☐
FPI Q4 2017
FPI Q3 2019
Data presented at SABCS 2019, ASCO 2020, ASCO
2021 and SABCS 2021
Π
Data presented at ASCO 2021
Status
CT Identifier
NCT03332797
NCT03916744
Roche
Safety, tolerability and PK/PD
FPI Q3 2020
Data presented at ESMO and SABCS 2021;
ASCO 2022
Data (biomarker subgroup analysis)
presented at ESMO 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 113
Breast Cancer Symposium; ASCO-American Society of Clinical Oncology
OncologyView entire presentation