Roche Pharmaceutical Development and Sales Overview
Inavolisib (RG6114, GDC-0077)
A potent, orally available, and selective PI3Ka inhibitor
Indication
Phase/study
# of patients
Design
PIK3CA-mutant HR+ metastatic breast cancer (mBC)
Phase III
INAVO120
N=400
■
ARM A: Inavolisib plus palbociclib plus fulvestrant
ARM B: Placebo plus palbociclib plus fulvestrant
Progression-free survival
Primary endpoint
FPI Q1 2020
Status
CT Identifier
NCT04191499
PIK3CA mutant solid tumors and metastatic
ER+ HER2-neg breast cancer
Phase I
Roche
N=256
Monotherapy and in combination with standard of care (letrozole; letrozole
plus palbociclib; fulvestrant)
Stage 1: Dose escalation
Stage 2: Dose expansion
■ 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 112
OncologyView entire presentation