[Biosimilars in oncology. Focus on SB3 studies]

Marzia Del Re; Lucia Del Mastro

doi:10.1701/3031.30290

[Biosimilars in oncology. Focus on SB3 studies]

Recenti Prog Med. 2018 Nov;109(11):531-539. doi: 10.1701/3031.30290.

[Article in Italian]

Authors

Marzia Del Re¹, Lucia Del Mastro²

Affiliations

¹ Dipartimento di Medicina Clinica e Sperimentale, Azienda Ospedaliero-Universitaria Pisana, Pisa.
² Dipartimento di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova - Dipartimento di Medicina Interna, DIMI, Università di Genova.

PMID: 30565572
DOI: 10.1701/3031.30290

Abstract

A phase III study compared SB3, a trastuzumab biosimilar, with trastuzumab originator in 800 HER2 positive breast cancer patients undergoing neoadjuvant chemotherapy. The aim of the study was to demonstrate the equivalence between the two drugs in terms of pathological complete responses. The total pathologic complete response rates were 51.7% and 42.0% with SB3 and trastuzumab, respectively. Equivalence for efficacy was demonstrated between SB3 and trastuzumab. Safety and immunogenicity were comparable.

Publication types

Comparative Study
Review

MeSH terms

Antineoplastic Agents, Immunological / administration & dosage
Antineoplastic Agents, Immunological / adverse effects
Biosimilar Pharmaceuticals / administration & dosage*
Biosimilar Pharmaceuticals / adverse effects
Breast Neoplasms / drug therapy*
Female
Humans
Neoadjuvant Therapy / methods
Receptor, ErbB-2 / metabolism
Trastuzumab / administration & dosage*
Trastuzumab / adverse effects
Treatment Outcome

Substances

Antineoplastic Agents, Immunological
Biosimilar Pharmaceuticals
ERBB2 protein, human
Receptor, ErbB-2
Trastuzumab