Half-Year 2022 Financial and Clinical Trials Update
Kadcyla
First ADC for HER2-positive breast cancer
Indication
HER2-positive early breast cancer (BC)
high-risk patients
2L+ HER-2 positive PD-L1 positive metastatic
breast cancer (mBC)
HER2-positive early breast cancer (BC)
high-risk patients
Phase/study
# of patients
Phase III
KATHERINE
N=1,484
☐
ARM A: Kadcyla 3.6mg/kg q3w
Phase III
KATE 3
N=320
ARM A: Kadcyla plus Tecentriq
Design
ARM B: Herceptin
◉
ARM B: Herceptin plus placebo
Phase III
ASTEFANIA
N=1700
▪ ARM A: Kadcyla plus Tecentriq
- ARM B: Kadcyla plus placebo
Primary endpoint
▪ Invasive disease-free survival
Progression-free survival and overall survival
■ Invasive disease-free survival
Status
•
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
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
84
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OncologyView entire presentation