Subcutaneous Fixed-Dose Pertuzumab/Trastuzumab Proves Noninferiority Versus IV Drugs

Published: Friday, Dec 13, 2019
Antoinette R. Tan, MD, chief of Breast Medical Oncology and co-director of the Phase I Program at the Levine Cancer Institute of Atrium Health

Antoinette R. Tan, MD

A subcutaneous (SC) fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) demonstrated noninferiority to intravenous formulations of the 2 drugs with respect to pharmacokinetics, clinical activity, and safety, a randomized trial demonstrated.1

The safety analysis showed that incidences of the most common adverse events (AEs) were similar between the 2 arms, including alopecia, nausea, diarrhea, anemia, and asthenia. Rates of specific AEs to monitor also were comparable, including diarrhea, neutropenia/febrile neutropenia, cardiac dysfunction, infusion/administration-related reactions within 24 hours of anti-HER2 therapy, interstitial lung disease, serious rash/skin reactions, serious mucositis, and pregnancy/neonatal-related AEs.


  1. Tan AR, Im S-A, Mattar A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at: 2019 San Antonio Breast Cancer Symposium. Poster PD4-07.
  2. Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7.
  3. Kirschbrown WP, Wynne C, Kagedal M, et al. Development of a subcutaneous fixed-dose combination of pertuzumab and trastuzumab: results from the phase Ib dose-finding study. J Clin Pharmacol. 2019 May;59(5):702-716. doi: 10.1002/jcph.1362.
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