Half-Year 2022 Financial and Clinical Trials Update
Inavolisib (RG6114, GDC-0077)
A potent, orally available, and selective PI3Ka inhibitor
Indication
PIK3CA-mutant HR+ metastatic breast cancer (mBC)
PIK3CA mutant solid tumors and metastatic
ER+ HER2-neg breast cancer
Roche
Phase/study
# of patients
Design
Phase III
INAVO120
N=400
ARM A: Inavolisib plus palbociclib plus fulvestrant
ARM B: Placebo plus palbociclib plus fulvestrant
Phase I
N=256
Monotherapy and in combination with standard of care (letrozole; letrozole
plus palbociclib; fulvestrant)
• Stage 1: Dose escalation
• Stage 2: Dose expansion
▪ Progression-free survival
Primary endpoint
Status
CT Identifier
FPI Q1 2020
NCT04191499
Safety, tolerability and pharmacokinetics
•
FPI Q4 2016
• Preclinical/molecule discovery data presented at AACR 2017
•
Data presented at SABCS 2019, 2020 and 2021
NCT03006172
ER=Estrogen receptor; HR=Hormon receptor; HER2=Human Epidermal growth factor Receptor 2; PI3K=Phosphoinositide 3-Kinase; AACR=American Association for Cancer Research; SABCS-San Antonio Breast Cancer Symposium 134
OncologyView entire presentation