Half-Year 2022 Financial and Clinical Trials Update
Perjeta
First-in-class HER2 dimerization inhibitor
Indication
Phase/study
# of patients
Design
Adjuvant HER2-positive breast cancer (BC)
Phase III
APHINITY
N=4,803
ARM A: Perjeta (840mg loading dose, 420mg q3w) plus Herceptin for 52 weeks plus chemotherapy (6-8 cycles)
ARM B: Placebo plus Herceptin (52 weeks) plus chemotherapy (6-8 cycles)
Primary endpoint
Status
CT Identifier
■ Invasive disease-free survival (iDFS)
ப
Primary endpoint met Q1 2017
Data presented at ASCO 2017 and published in NEJM 2017; 377:122-131
■ Filed in US and EU Q3 2017
Approved in US Q4 2017 (priority review) and EU Q2 2018
6-year IDFS data presented at SABCS 2019
8-year iDFS data presented at ESMO virtual 2022
NCT01358877
HER2-Human Epidermal growth factor Receptor 2, IDFS=Invasive disease-free survival; ASCO-American Society of Clinical Oncology; NEJM-New England Journal of Medcine; SABCS-San Antonio Breast Cancer Symposium
85
Roche
OncologyView entire presentation