Roche Pharmaceutical Development and Sales Overview
Perjeta (pertuzumab, RG1273)
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)
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ARM B: Placebo plus Herceptin (52 weeks) plus chemotherapy (6-8 cycles)
Invasive disease-free survival (iDFS)
Primary endpoint
Status
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
CT Identifier
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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
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