Roche Pharmaceutical Development and Sales Overview
Kadcyla (trastuzumab emtansine, RG3502)
First ADC for HER2-positive breast cancer
Indication
Phase/study
# of patients
Design
Primary endpoint
Status
HER2-positive early breast cancer (BC)
high-risk patients
2L+ HER-2 positive PD-L1 positive metastatic
breast cancer (mBC)
Phase III
KATHERINE
N=1,484
■
ARM A: Kadcyla 3.6mg/kg q3w
☐
☐
ARM B: Herceptin
Invasive disease-free survival
"
"
☐
Recruitment completed Q4 2015
Stopped at pre-planned interim data analysis
for efficacy Q4 2018
Data presented at SABCS 2018
BTD granted by FDA in Q1 2019
US filling completed under RTOR Q1 2019 and
filed in EU Q1 2019
Approved in US Q2 2019 and in EU Q4 2019
Data published in NEJM 2019; 380:617-628
Phase III
KATE 3
N=320
ARM A: Kadcyla plus Tecentriq
ARM B: Kadcyla plus placebo
☐
HER2-positive early breast cancer (BC)
high-risk patients
Phase III
ASTEFANIA
N=1,700
ARM A: Kadcyla plus Tecentriq
ARM B: Kadcyla plus placebo
Progression-free survival and overall survival
Invasive disease-free survival
FPI Q1 2021
FPI Q2 2021
CT Identifier
In collaboration with ImmunoGen, Inc.
NCT01772472
NCT04740918
NCT04873362
ADC=antibody drug conjugate; BTD=Breakthrough therapy designation; HER2=Human Epidermal growth factor Receptor 2; SABCS-San Antonio Breast Cancer Symposium; RTOR=Real time oncology review; NEJM-New England
Journal of Medicine
Roche
63
OncologyView entire presentation