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Drug Evaluation

Margetuximab in HER2-positive metastatic breast cancer

ORCID Icon, ORCID Icon, ORCID Icon, , & ORCID Icon
Pages 1099-1112 | Received 20 Oct 2022, Accepted 06 Apr 2023, Published online: 12 May 2023

References

  • American Cancer Society . Cancer facts & figures 2023.American Cancer Society, 1–84 (2023). www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts-figures.html
  • Wolff AC , HammondMEH, AllisonKHet al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline focused update. J. Clin. Oncol.36(20), 2105–2122 (2018).
  • NCCN . Clinical practice guidelines in oncology, breast cancer (v1.2023). www.nccn.org/professionals/physician_gls/pdf/breast.pdf
  • Owens MA , HortenBC, DaSilva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin. Breast Cancer5(1), 63–69 (2004).
  • NCI . Cancer stat facts: female breast cancer subtypes.Surveillance, Epidemiology, and End Results (SEER) program. https://seer.cancer.gov/statfacts/html/breast-subtypes.html
  • Gennari A , AndreF, BarriosCHet al. on behalf of the ESMO Guidelines Committee . ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann. Oncol.32(12), 1475–1495 (2021).
  • Giordano SH , FranzoiMAB, TeminSet al. Systemic therapy for advanced human epidermal growth factor receptor 2-positive breast cancer: ASCO guideline update. J. Clin. Oncol.40(23), 2612–2635 (2022).
  • Cameron D , CaseyM, OlivaC, NewstatB, ImwalleB, GeyerCE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist15(9), 924–934 (2010).
  • Blackwell KL , BursteinHJ, StornioloAMet al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J. Clin. Oncol.28(7), 1124–1130 (2010).
  • Krop IE , KimSB, González-MartinAet al. on behalf of the TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician’s choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol.15(7), 689–699 (2014).
  • Krop IE , KimSB, GonzalezMartin Aet al. Trastuzumab emtansine versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol.18(6), 743–754 (2017).
  • von Minckwitz G , SchwedlerK, SchmidtMet al. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur. J. Cancer47(15), 2273–2281 (2011).
  • MARGENZA® (margetuximab-cmkb): US prescribing information. MacroGenics, Inc., MD, USA (2020). www.margenza.com/pdf/prescribing-information.pdf
  • ENHERTU® (fam-trastuzumab deruxtecan-nxki). US prescribing information. Daiichi Sankyo, Inc., NJ, USA (2022). https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Enhertu&inline=true
  • TUKYSA® (tucatinib) tablets: US prescribing information. Seagen Inc., WA, USA (2023). https://seagendocs.com/TUKYSA_Full_Ltr_Master.pdf
  • NERLYNX® (neratinib) tablets: US prescribing information. Puma Biotechnology, Inc., Los Angeles, CA (2022). https://nerlynxhcp.com/pdf/full-prescribing-information.pdf
  • Saura Manich C , ModiS, KropIet al. Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer (MBC): updated survival results from a phase II trial (DESTINY-Breast01). Ann. Oncol.32(Suppl. 5), Abstract 279P (2021).
  • Murthy RK , LoiS, OkinesAet al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N. Engl. J. Med.382(7), 597–609 (2020).
  • Rugo HS , ImS-A, CardosoFet al. Margetuximab versus trastuzumab in patients with previously treated HER2-positive advanced breast cancer (SOPHIA): final overall survival results from a randomized phase 3 trial. J. Clin. Oncol.41(2), 198–205 (2023).
  • Liu L , YangY, BurnsRet al. Margetuximab mediates greater Fc-dependent anti-tumor activities than trastuzumab or pertuzumab in vitro. Cancer Res.79(Suppl. 13), Abstract 1538 (2019).
  • Nordstrom JL , GorlatovS, ZhangWet al. Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties. Breast Cancer Res.13(6), R123 (2011).
  • Slamon DJ , Leyland-JonesB, ShakSet al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med.344(11), 783–792 (2001).
  • Stavenhagen JB , GorlatovS, TuaillonNet al. Enhancing the potency of therapeutic monoclonal antibodies via Fc optimization. Adv. Enzyme Regul.48, 152–164 (2008).
  • Stavenhagen JB , GorlatovS, TuaillonNet 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 Fcgamma receptors. Cancer Res.67(18), 8882–8890 (2007).
  • Bang YJ , GiacconeG, ImSAet 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.28(4), 855–861 (2017).
  • Musolino A , GradisharWJ, RugoHSet al. Role of Fcγ receptors in HER2-targeted breast cancer therapy. J. Immunother. Cancer10(1), e003171 (2022).
  • Nordstrom JL , MuthJ, ErskineCLet al. High frequency of HER2-specific immunity observed in patients (pts) with HER2+ cancers treated with margetuximab (M), an Fc-enhanced anti-HER2 monoclonal antibody (mAb). J. Clin. Oncol.37(Suppl. 15), Abstract 1030 (2019).
  • Gavin PG , SongN, KimSRet al. Association of polymorphisms in FCGR2A and FCGR3A with degree of trastuzumab benefit in the adjuvant treatment of ERBB2/HER2-positive breast cancer: analysis of the NSABP B-31 trial. JAMA Oncol.3(3), 335–341 (2017).
  • Musolino A , NaldiN, BortesiBet 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.26(11), 1789–1796 (2008).
  • Musolino A , NaldiN, DieciMVet al. Immunoglobulin G fragment C receptor polymorphisms and efficacy of preoperative chemotherapy plus trastuzumab and lapatinib in HER2-positive breast cancer. Pharmacogenomics J.16(5), 472–477 (2016).
  • Tamura K , ShimizuC, HojoTet al. FcγR2A and 3A polymorphisms predict clinical outcome of trastuzumab in both neoadjuvant and metastatic settings in patients with HER2-positive breast cancer. Ann. Oncol.22(6), 1302–1307 (2011).
  • Hurvitz SA , BettingDJ, SternHMet al. Analysis of Fcγ receptor IIIa and IIa polymorphisms: lack of correlation with outcome in trastuzumab-treated breast cancer patients. Clin. Cancer Res.18(12), 3478–3486 (2012).
  • Norton N , OlsonRM, PegramMet al. Association studies of Fcγ receptor polymorphisms with outcome in HER2+ breast cancer patients treated with trastuzumab in NCCTG (Alliance) Trial N9831. Cancer Immunol. Res.2(10), 962–969 (2014).
  • Royce M , OsgoodCL, AmatyaAKet al. FDA approval summary: margetuximab plus chemotherapy for advanced or metastatic HER2-positive breast cancer. Clin. Cancer Res.28(8), 1487–1492 (2022).
  • Im SA , BangYJ, OhDYet al. Long-term responders to single-agent margetuximab, an Fc-modified anti-HER2 monoclonal antibody, in metastatic HER2+ breast cancer patients with prior anti-HER2 therapy. Cancer Res.79(Suppl. 4), Abstract P6-18-11 (2019).
  • Pegram MD , Tan-ChiuE, MillerKet al. A single-arm, open-label, phase 2 study of MGAH22 (margetuximab) [fc-optimized chimeric anti-HER2 monoclonal antibody (mAb)] in patients with relapsed or refractory advanced breast cancer whose tumors express HER2 at the 2+ level by immunohistochemistry and lack evidence of HER2 gene amplification by FISH. J. Clin. Oncol.32(Suppl. 15), Abstract TPS671 (2014).
  • Rugo HS , ImSA, CardosoFet al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer: a phase 3 randomized clinical trial. JAMA Oncol.7(4), 573–584 (2021).
  • Escrivá S , ImSA, CardosoFet 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.38(Suppl. 15), Abstract 1040 (2020).
  • Im SA , CardosoF, CortesJet al. Integrated safety summary of single agent and combination margetuximab in phase 1, 2, and 3 studies of HER2-positive advanced cancers and metastatic breast cancer (MBC). Cancer Res.81(Suppl. 4), Abstract PS10-12 (2021).
  • Cortes J , CardosoF, CuriglianoGet al. Infusion related reactions in the phase 3 SOPHIA trial of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with pretreated HER2+ metastatic breast cancer. Cancer Res.81(Suppl. 4), Abstract PS10-24 (2021).
  • HERCEPTIN® (trastuzumab): US prescribing information. Genentech, Inc., CA, USA (2021). www.gene.com/download/pdf/herceptin_prescribing.pdf
  • Thompson LM , EckmannK, BosterBLet al. Incidence, risk factors, and management of infusion-related reactions in breast cancer patients receiving trastuzumab. Oncologist19(3), 228–234 (2014).
  • Gradishar WJ , ImS-A, CardosoFet al. Phase 3 SOPHIA study of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: Infusion time substudy results. Cancer Res.80(Suppl. 4), Abstract P1-18-04 (2020).
  • PERJETA® (pertuzumab): US prescribing information. Genentech, Inc., CA, USA (2021). www.gene.com/download/pdf/perjeta_prescribing.pdf
  • KADCYLA® (ado-trastuzumab emtansine): US prescribing information. Genentech, Inc.; CA, USA (2022). www.gene.com/download/pdf/kadcyla_prescribing.pdf
  • TYKERB® (lapatinib) tablets: US prescribing information. Novartis Pharmaceuticals Corp., NJ, USA (2022). www.novartis.us/sites/www.novartis.us/files/tykerb.pdf
  • Cardoso F , CortesJ, GradisharWet al. Health-related quality of life for margetuximab + chemotherapy vs. trastuzumab + chemotherapy in the phase 3 SOPHIA trial of patients with pretreated HER2+ metastatic breast cancer. Cancer Res.81(Suppl. 4), Abstract PS9-11 (2021).
  • Zai Lab . Zai Lab announces margetuximab achieved primary objective in bridging study in advanced HER2+ breast cancer in greater China. https://ir.zailaboratory.com/node/9636/pdf
  • Zai Lab . Zai Lab announces NDA acceptance of margetuximab for patients with pretreated metastatic HER2-positive breast cancer in China by the NMPA. https://ir.zailaboratory.com/node/10036/pdf
  • Andersson M , LidbrinkE, BjerreKet al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J. Clin. Oncol.29(3), 264–271 (2011).
  • Esfahani K , FerrarioC, LeP, PanasciL. The trastuzumab and vinorelbine combination: an alternative to taxane-based chemotherapy for early-stage and locally advanced HER2-positive breast cancer. Curr. Oncol.21(5), e723–727 (2014).
  • Dang C , IyengarN, DatkoFet al. Phase II study of paclitaxel given once per week along with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. J. Clin. Oncol.33(5), 442–447 (2015).
  • Smyth LM , IyengarNM, ChenMFet al. Weekly paclitaxel with trastuzumab and pertuzumab in patients with HER2-overexpressing metastatic breast cancer: overall survival and updated progression-free survival results from a phase II study. Breast Cancer Res. Treat.158(1), 91–97 (2016).
  • Blackwell KL , BursteinHJ, StornioloAMet al. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J. Clin. Oncol.30(21), 2585–2592 (2012).
  • Swain SM , BaselgaJ, KimSBet al. for the CLEOPATRA Study Group . Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N. Engl. J. Med.372(8), 724–734 (2015).
  • Swain SM , KimSB, CortesJet al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol.14(6), 461–471 (2013).
  • Swain SM , MilesD, KimSBet al. on behalf of the CLEOPATRA study group . Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol.21(4), 519–530 (2020).
  • Bartsch R , WenzelC, AltorjaiGet al. Capecitabine and trastuzumab in heavily pretreated metastatic breast cancer. J. Clin. Oncol.25(25), 3853–3858 (2007).
  • Baselga J , CortésJ, KimSBet al. for the CLEOPATRA Study Group . Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N. Engl. J. Med.366(2), 109–119 (2012).
  • Burstein HJ , KeshaviahA, BaronADet al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer110(5), 965–972 (2007).
  • Cobleigh MA , VogelCL, TripathyDet al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J. Clin. Oncol.17(9), 2639–2648 (1999).
  • Esteva FJ , ValeroV, BooserDet al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J. Clin. Oncol.20(7), 1800–1808 (2002).
  • Geyer CE , ForsterJ, LindquistDet al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N. Engl. J. Med.355(26), 2733–2743 (2006).
  • Leyland-Jones B , GelmonK, AyoubJPet al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J. Clin. Oncol.21(21), 3965–3971 (2003).
  • Marty M , CognettiF, MaraninchiDet al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J. Clin. Oncol.23(19), 4265–4274 (2005).
  • Modi S , SauraC, YamashitaTet al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N. Engl. J. Med.382(7), 610–621 (2020).
  • Perez EA , SumanVJ, RowlandKMet al. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin. Breast Cancer6(5), 425–432 (2005).
  • Robert N , Leyland-JonesB, AsmarLet al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J. Clin. Oncol.24(18), 2786–2792 (2006).
  • Saura C , OliveiraM, FengYHet al. for the NALA Investigators . 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.38(27), 3138–3149 (2020).
  • Seidman AD , BerryD, CirrincioneCet al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J. Clin. Oncol.26(10), 1642–1649 (2008).
  • Verma S , MilesD, GianniLet al. for the EMILIA Study Group . Trastuzumab emtansine for HER2-positive advanced breast cancer. N. Engl. J. Med.367(19), 1783–1791 (2012).
  • von Minckwitz G , du BoisA, SchmidtMet al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German Breast Group 26/Breast International Group 03–05 study. J. Clin. Oncol.27(12), 1999–2006 (2009).
  • Cortés J , KimS-B, ChungW-Pet al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N. Engl. J. Med.386(12), 1143–1154 (2022).
  • Modi S , JacotW, YamashitaTet al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N. Engl. J. Med.387(1), 9–20 (2022).
  • Quest Diagnostics . CD16A (FCGR3A) F158V polymorphism analysis. https://testdirectory.questdiagnostics.com/test/test-detail/34493/cd16a-fcgr3a-f158v-polymorphism-analysis?cc=MASTER