A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab

The reduced cost of trastuzumab biosimilars has led to increased adoption for HER2-positive breast cancer. This review of trastuzumab biosimilars encompasses this development and real world clinical data in early breast cancer. In addition, we present a retrospective study evaluating the total patho...

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Main Authors: Charlie Yang, Raida Khwaja, Patricia Tang, Nancy Nixon, Karen King, Sasha Lupichuk
Format: Article
Language:English
Published: MDPI AG 2022-06-01
Series:Current Oncology
Subjects:
Online Access:https://www.mdpi.com/1718-7729/29/6/337
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author Charlie Yang
Raida Khwaja
Patricia Tang
Nancy Nixon
Karen King
Sasha Lupichuk
author_facet Charlie Yang
Raida Khwaja
Patricia Tang
Nancy Nixon
Karen King
Sasha Lupichuk
author_sort Charlie Yang
collection DOAJ
description The reduced cost of trastuzumab biosimilars has led to increased adoption for HER2-positive breast cancer. This review of trastuzumab biosimilars encompasses this development and real world clinical data in early breast cancer. In addition, we present a retrospective study evaluating the total pathological complete response (tpCR) rates (lack of residual invasive cancer in resected breast tissue and axillary nodes), of MYL-1401O to reference trastuzumab (TRZ) in the neoadjuvant setting for HER2+ early breast cancer (EBC) in Alberta, Canada. Neoadjuvant patients with HER2+ EBC treated with TRZ from November 2018–October 2019 and MYL-1401O from December 2019–September 2020 were identified. Logistic regression was used to control for variables potentially associated with tpCR: trastuzumab product, age, pre-operative T- and N-stage, grade, hormone receptor (HR)-status, HER2-status, chemotherapy regimen, and chemotherapy completion. tpCR was 35.6% in the MYL-1401O group (<i>n</i> = 59) and 40.3% in the TRZ (<i>n</i> = 77) group, <i>p</i> = 0.598. After controlling for clinically relevant variables, there was no significant difference in the odds of achieving tpCR in patients treated with TRZ versus MYL-1401O (OR 1.1, 95% CI 0.5–2.4, <i>p</i> = 0.850). tpCR rates were similar for patients treated with MYL-1401O compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials.
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spelling doaj.art-54fb96f00a8f465ca1356ccb18df6fe32023-11-23T16:14:11ZengMDPI AGCurrent Oncology1198-00521718-77292022-06-012964224423410.3390/curroncol29060337A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference TrastuzumabCharlie Yang0Raida Khwaja1Patricia Tang2Nancy Nixon3Karen King4Sasha Lupichuk5Department of Oncology, Tom Baker Cancer Centre, Calgary, AB T2N4N2, CanadaDepartment of Oncology, Cross Cancer Institute, Edmonton, AB T6G1Z2, CanadaDepartment of Oncology, Tom Baker Cancer Centre, Calgary, AB T2N4N2, CanadaDepartment of Oncology, Tom Baker Cancer Centre, Calgary, AB T2N4N2, CanadaDepartment of Oncology, Cross Cancer Institute, Edmonton, AB T6G1Z2, CanadaDepartment of Oncology, Tom Baker Cancer Centre, Calgary, AB T2N4N2, CanadaThe reduced cost of trastuzumab biosimilars has led to increased adoption for HER2-positive breast cancer. This review of trastuzumab biosimilars encompasses this development and real world clinical data in early breast cancer. In addition, we present a retrospective study evaluating the total pathological complete response (tpCR) rates (lack of residual invasive cancer in resected breast tissue and axillary nodes), of MYL-1401O to reference trastuzumab (TRZ) in the neoadjuvant setting for HER2+ early breast cancer (EBC) in Alberta, Canada. Neoadjuvant patients with HER2+ EBC treated with TRZ from November 2018–October 2019 and MYL-1401O from December 2019–September 2020 were identified. Logistic regression was used to control for variables potentially associated with tpCR: trastuzumab product, age, pre-operative T- and N-stage, grade, hormone receptor (HR)-status, HER2-status, chemotherapy regimen, and chemotherapy completion. tpCR was 35.6% in the MYL-1401O group (<i>n</i> = 59) and 40.3% in the TRZ (<i>n</i> = 77) group, <i>p</i> = 0.598. After controlling for clinically relevant variables, there was no significant difference in the odds of achieving tpCR in patients treated with TRZ versus MYL-1401O (OR 1.1, 95% CI 0.5–2.4, <i>p</i> = 0.850). tpCR rates were similar for patients treated with MYL-1401O compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials.https://www.mdpi.com/1718-7729/29/6/337trastuzumabbiosimilarMYL-1401OHER2+breast cancerearly stage
spellingShingle Charlie Yang
Raida Khwaja
Patricia Tang
Nancy Nixon
Karen King
Sasha Lupichuk
A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
Current Oncology
trastuzumab
biosimilar
MYL-1401O
HER2+
breast cancer
early stage
title A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
title_full A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
title_fullStr A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
title_full_unstemmed A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
title_short A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
title_sort review of trastuzumab biosimilars in early breast cancer and real world outcomes of neoadjuvant myl 1401o versus reference trastuzumab
topic trastuzumab
biosimilar
MYL-1401O
HER2+
breast cancer
early stage
url https://www.mdpi.com/1718-7729/29/6/337
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