Further Data Demonstrate Equivalence for Subcutaneous, IV Formulations of Trastuzumab in HER2+ Breast Cancer

Published: Friday, Dec 13, 2019
Sherko Kummel, MD, of Kliniken Essen-Mitte in Germany

Sherko Kümmel, MD

Subcutaneous (SC) trastuzumab with hyaluronidase-oysk (Herceptin Hylecta) in combination with intravenous (IV) pertuzumab (Perjeta) and chemotherapy had a safety profile consistent with IV trastuzumab as first-line treatment for metastatic HER2-positive breast cancer, according to results of a large single-arm phase IIIb trial.

Overall, about half of 412 patients had grade ≥3 adverse events (AEs), one fifth had AEs leading to drug withdrawal, and about a third had AEs leading to drug interruption. Among AEs to monitor, diarrhea, mucositis, and rash occurred most often. Aside from hematologic AEs, grade ≥3 AEs to monitor were uncommon. Investigator-reported AEs/grade ≥3 AEs also were infrequent.

An exploratory efficacy analysis also yielded results consistent with historical data from the landmark CLEOPATRA trial, Sherko Kümmel, MD, of Kliniken Essen-Mitte in Germany, reported at the 2019 San Antonio Breast Cancer Symposium (SABCS).1,2

“The CLEOPATRA trial was practice changing and established IV pertuzumab plus IV trastuzumab with chemotherapy, followed by IV trastuzumab and chemotherapy, as standard of care for patients with HER2-overexpressing metastatic breast cancer,”. Kümmel told OncLive. “This is the second trial of that treatment, and even though it is not a randomized trial, it affirms the efficacy of the CLEOPATRA trial, in terms of PFS (progression-free survival) and OS (overall survival).”

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