Half-Year 2022 Financial and Clinical Trials Update slide image

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 00 Oncology
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