Margetuximab for the treatment of HER2-positive metastatic breast cancer

References

• Owens MA, Horten BC, Da Silva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer. 2004;5(1):63–69.
   PubMedGoogle Scholar
• Pernas S, Tolaney SM. HER2-positive breast cancer: new therapeutic frontiers and overcoming resistance. Ther Adv Med Oncol. 2019;11:175883591983351.
   Web of Science ®Google Scholar
• Cesca MG, Vian L, Cristóvão-Ferreira S, et al. HER2-positive advanced breast cancer treatment in 2020. Cancer Treat Rev. 2020;88:102033.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)†. Annals of Oncology. 2020;31(12):1623–1649.
   Web of Science ®Google Scholar
• Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2019. DOI:https://doi.org/10.1056/NEJMoa1914510.
   Google Scholar
• Murthy RK, Loi S, Okines A, et al. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2019;NEJMoa1914609. DOI:https://doi.org/10.1056/NEJMoa1914609.
   Google Scholar
• Saura C, Oliveira M, Feng YH, et al. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: phase III NALA Trial. J Clin Oncol. 2020;147. DOI:https://doi.org/10.1200/JCO.20.00147.
   Google Scholar
• Cardoso F, Senkus E, Costa A, et al. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4). Ann. Oncol. 2018;29(8):1634–1657.
   PubMed Web of Science ®Google Scholar
• Lin NU, Borges V, Anders C, et al. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020;00775. DOI:https://doi.org/10.1200/JCO.20.00775.
   Google Scholar
• Emens LA, Esteva FJ, Beresford M, et al. 305OOverall survival (OS) in KATE2, a phase II study of programmed death ligand 1 (PD-L1) inhibitor atezolizumab (atezo)+trastuzumab emtansine (T-DM1) vs placebo (pbo)+T-DM1 in previously treated HER2+ advanced breast cancer (BC). Ann Oncol. 2019;30:v104.
   Web of Science ®Google Scholar
• Stavenhagen JB, Gorlatov S, Tuaillon N, et al. Fc Optimization of Therapeutic Antibodies Enhances Their Ability to Kill Tumor Cells In vitro and Controls Tumor Expansion In vivo via Low-Affinity Activating Fc Receptors. Cancer Res. 2007;67(18):8882–8890.
   PubMed Web of Science ®Google Scholar
• Nordstrom JL, Gorlatov S, Zhang W, et al. Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties. Breast Cancer Res. 2011;13(6):R123.
   PubMed Web of Science ®Google Scholar
• Lehrnbecher T, Foster CB, Zhu S, et al. Variant Genotypes of the Low-Affinity Fcγ Receptors in Two Control Populations and a Review of Low-Affinity Fcγ Receptor Polymorphisms in Control and Disease Populations. Blood. 1999;94(12):4220–4232.
   PubMed Web of Science ®Google Scholar
• Musolino A, Naldi N, Bortesi B, et al. Immunoglobulin G Fragment C Receptor Polymorphisms and Clinical Efficacy of Trastuzumab-Based Therapy in Patients With HER-2/neu –Positive Metastatic Breast Cancer. J. Clin. Oncol. 2008;26(11):1789–1796.
   PubMed Web of Science ®Google Scholar
• Pereira NA, Chan KF, Lin PC, et al. The “less-is-more” in therapeutic antibodies: afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity. MAbs. 2018;10:693–711.
   PubMed Web of Science ®Google Scholar
• Tarantino P, Hamilton E, Tolaney SM, et al. HER2-Low Breast Cancer: pathological and Clinical Landscape. J Clin Oncol. 2020;38(17):1951–1962.
   PubMed Web of Science ®Google Scholar
• Bang YJ, Giaccone G, Im SA, et al. First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors. Ann. Oncol. 2017;28(4):855–861.
   PubMed Web of Science ®Google Scholar
• Leveque D, Gigou L, Bergerat J. Clinical Pharmacology of Trastuzumab. Curr Clin Pharmacol. 2008;3:51–55.
   PubMedGoogle Scholar
• [cited 2020 Sept 23]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT01828021.
   Google Scholar
• Catenacci DVT, Kang Y-K, Park H, et al. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22–05): a single-arm, phase 1b–2 trial. Lancet Oncol. 2020;21(8):1066–1076.
   PubMed Web of Science ®Google Scholar
• Rugo HS, Im S-A, Wright GLS, et al. SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx). J. Clin. Oncol. 2019;37(15_suppl):1000.
   Web of Science ®Google Scholar
• Rugo HS, Im SA, Cardoso F, et al. Abstract GS1-02: phase 3 SOPHIA study of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: second interim overall survival analysis. General Session Abstracts GS1-02-GS1-02 (American Association for Cancer Research, 2020) 2020. doi:https://doi.org/10.1158/1538-7445.SABCS19-GS1-02.
   Google Scholar
• Escrivá S, Im S-A, Cardoso F, et al. SOPHIA analysis by chemotherapy (Ctx) choice: A phase III (P3) study of margetuximab (M) + Ctx versus trastuzumab (T) + Ctx in patients (pts) with pretreated HER2+ metastatic (met) breast cancer (MBC). J. Clin. Oncol. 2020;38(15_suppl):1040.
   Web of Science ®Google Scholar
• Tarantino P, Morganti S, Curigliano G. Biologic therapy for advanced breast cancer: recent advances and future directions. Expert Opin Biol Ther. 2020;20:1009–1024.
   PubMed Web of Science ®Google Scholar
• Murthy R, Borges VF, Conlin A, et al. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018;19(7):880–888.
   PubMed Web of Science ®Google Scholar
• Lin NU, Borges V, Anders C, et al. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020;775. DOI:https://doi.org/10.1200/JCO.20.00775.
   Google Scholar
• Mailankody S, Prasad V. Five Years of Cancer Drug Approvals. JAMA Oncol. 2015;1:539.
   PubMed Web of Science ®Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 2012;367(19):1783–1791.
   PubMed Web of Science ®Google Scholar
• Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab-Refractory Metastatic Breast Cancer. J. Clin. Oncol. 2010;28(7):1124–1130.
   PubMed Web of Science ®Google Scholar
• Pivot X, Manikhas A, Żurawski B, et al. CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J. Clin. Oncol. 2015;33(14):1564–1573.
   PubMed Web of Science ®Google Scholar
• Tolaney SM, Wardley AM, Zambelli S, et al. A monarcHER: a Randomized Phase 2 study of Abemaciclib plus Trastuzumab with or without fulvestrant versus trastuzumab plus standard of care chemotherapy in women with HR+, HER2+ Advanced Breast Cancer (ABC). Ann Oncol. 2019;30:v851–v934.
   Web of Science ®Google Scholar
• Park YH, Lee K-H, Sohn JH, et al. A phase II trial of the pan-HER inhibitor poziotinib, in patients with HER2-positive metastatic breast cancer who had received at least two prior HER2-directed regimens: results of the NOV120101-203 trial. Int J Cancer. 2018;143(12):3240–3247.
   PubMed Web of Science ®Google Scholar
• Xu B, Yan M, Ma F, et al. Pyrotinib or lapatinib plus capecitabine for HER2+ metastatic breast cancer (PHOEBE): A randomized phase III trial. J. Clin. Oncol. 2020;38(15_suppl):1003.
   PubMedGoogle Scholar