Page 11 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

5.2. How hyaluronidase is thought to work? 39

Hyaluronidase increases permeability of the SC tissue by
depolymerizing hyaluronan, based on preclinical studies.
In the doses administered, hyaluronidase in the fixed-dose SC
combination of trastuzumab and pertuzumab acts transiently and
locally.
The effects of hyaluronidase are reversible, and permeability of the
SC tissue is restored within 24 to 48 hours.
Hyaluronidase has been shown to increase the absorption rate of a
trastuzumab product into the systemic circulation, based on animal
studies.

6. FIXED-DOSE SC COMBINATION OF TRASTUZUMAB AND

PERTUZUMAB: CLINICAL EFFICACY AND SAFETY

6.1. FeDeriCa

FeDeriCa evaluated the pharmacokinetics (PK), efficacy, and safety of fixed-dose
SC combination of trastuzumab and pertuzumab vs IV pertuzumab + trastuzumab.

Study design 39,46,47
Phase III, randomized, open-label trial designed to demonstrate non-inferiority of

fixed-dose SC combination of trastuzumab and pertuzumab compared to IV
PERJETA and trastuzumab.
®
Neoadjuvant treatment Adjuvant treatment
fixed-dose SC combination of trastuzumab
ddAC (4 cycles) and pertuzumab* (4 cycles)
R Paclitaxel (12 weekly cycles)
A n=248 fixed-dose SC combination of trastuzumab fixed-dose SC
combination of trastuzumab and
Patients with operable or N AC (4 cycles) and pertuzumab* (4 cycles) S pertuzumab * (14 cycles, to complete F
locally advanced D Docetaxel (4 cycles) U 18 cycles of HER2-targeted therapy) O L
O
(including inflammatory) M R L
HER2+ eBC I G O
(with tumor size >2 cm Z E W
or node-positive) A IV PERJETA ® + trastuzumab † (4 cycles) R Y IV PERJETA ® + trastuzumab †
(N=500) T I ddAC (4 cycles) (14 cycles, to complete U P
18 cycles of
O n=252 Paclitaxel (12 weekly cycles) HER2-targeted therapy)
N IV PERJETA ® + trastuzumab † (4 cycles)
AC (4 cycles)
Docetaxel (4 cycles)
Treatment cycles with fixed-dose SC combination of trastuzumab and pertuzumab
or IV PERJETA + trastuzumab were received every 3 weeks.
®
Patients received adjuvant radiotherapy and endocrine therapy as per investigator’s
discretion.

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