Roche Pharmaceutical Development and Sales Overview
Phesgo (pertuzumab/trastuzumab, RG6264)
FDC of Perjeta and Herceptin for subcutaneous administration
Indication
HER2-positive early breast cancer (BC)
Phase/study
# of patients
Design
Primary endpoint
Status
Phase III
FeDeriCa
N=500
FDC of Perjeta and Herceptin for SC
administration (Phesgo) in combination with
chemotherapy in neoadjuvant/adjuvant setting
ARM A: Perjeta IV plus Herceptin IV plus
chemotherapy
◉
ARM B: Phesgo plus chemotherapy
Trough Serum Concentration (Ctrough) of
Perjeta during cycle 7
Primary endpoint met Q3 2019
Data presented at SABCS 2019
Data published in Lancet Oncology 2021
Jan;22(1):85-97
Phase II
PHranceSCa
N=160
ARM A: Perjeta and Herceptin IV followed by
Phesgo
ARM B: Phesgo followed by IV
Percentage of patients who preferred Perjeta
and Herceptin FDC SC
Final analysis completed, 85% patients
preferred FDC SC
◉
Data presented at ESMO 2020
Data published in Eur J Cancer 2021
Jul;152:223-232
☐
Filed in US Dec 2019 & in EU Jan 2020; Approved in US Q2 2020 and EU Q4 2020
■
HER2-positive breast cancer (BC)
Phase I¹
N=144
ARM A: Phesgo administered using a
handheld syringe with hypodermic needle
(SC)
ARM B: Phesgo administered using the on-
body delivery system (OBI)
AUCO-62*, Cmax**
☐
FPI Q2 2022
CT Identifier
NCT03493854
In collaboration with West Pharmaceuticals and Halozyme
NCT03674112
NCT05275010
*AUCO-62-comparability of area under the time-concentration curve from the start of dosing to 63 days; **Cmax=maximum serum concentration for pertuzumab and trastuzumab within Phesgo; FDC=Fixed-dose combination;
Phesgo-FDC of Perjeta and Herceptin for SC administration; HER2-Human Epidermal growth factor Receptor 2, IV-intravenous; SC-Subcutaneous; ASCO=American Society of Clinical Onclogy; NEJM-New England Journal of Medcine;
SABCS-San Antonio Breast Cancer Symposium; Eur J Cancer-European Journal of Cancer; ESMO-European Society for Medical Oncology
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OncologyView entire presentation