Trastuzumab Deruxtecan for HER2+ Advanced Breast Cancer

References

• Cronin KA , HarlanLC, DoddKW, AbramsJS, Ballard-BarbashR. Population-based estimate of the prevalence of HER-2 positive breast cancer tumors for early stage patients in the US. Cancer Invest.28(9), 963–968 (2010).
   PubMed Web of Science ®Google Scholar
• Giannone G , MontemurroF. A new player in the treatment of HER2+ tumours. Lancet Oncol.20(6), 748–750 (2019).
   PubMed Web of Science ®Google Scholar
• NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) . Breast cancer. Ver3.2021 (2021). www.nccn.org
   Google Scholar
• Giordano SH , TeminS, ChandarlapatySet al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: ASCO clinical practice guideline update. J. Clin. Oncol.36(26), 2736–2740 (2018).
   PubMed Web of Science ®Google Scholar
• Murthy RK , LoiS, OkinesAet al. Tucatinib, trastuzumab, and capecitabine for HER2+ metastatic breast cancer. N. Engl. J. Med.382(7), 597–609 (2020).
   PubMed Web of Science ®Google Scholar
• Shah M , WedamS, ChengJet al. FDA approval summary: tucatinib for the treatment of patients with advanced or metastatic HER2+ breast cancer. Clin. Cancer Res.27(5), 1220–1226 (2021).
   PubMed Web of Science ®Google Scholar
• Corti C , CriscitielloC. Tucatinib approval by EMA expands options for HER2+ locally advanced or metastatic breast cancer. ESMO Open6(2), 100063 (2021).
   PubMed Web of Science ®Google Scholar
• FDA approves neratinib for metastatic HER2+ breast cancer (2021). www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neratinib-metastatic-her2-positive-breast-cancer
   Google Scholar
• Saura C , OliveiraM, FengYHet al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2+ metastatic breast cancer previously treated with ≥2 HER2-directed regimens: phase III NALA Trial. J. Clin. Oncol.38(27), 3138–3149 (2020).
   PubMed Web of Science ®Google Scholar
• Bang YJ , GiacconeG, ImSAet al. First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2+ advanced solid tumors. Ann. Oncol.28(4), 855–861 (2017).
   PubMed Web of Science ®Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• FDA approves margetuximab for metastatic HER2+ breast cancer (2021). www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-margetuximab-metastatic-her2-positive-breast-cancer
   Google Scholar
• Kim TM , LeeK-W, OhD-Yet al. Phase 1 studies of poziotinib, an irreversible pan-HER tyrosine kinase inhibitor in patients with advanced solid tumors. Cancer Res. Treat.50(3), 835–842 (2018).
   PubMed Web of Science ®Google Scholar
• Im SA , KimJH, LeeKHet al. Abstract P4-13-19: poziotinib, an oral, irreversible pan-HER inhibitor, demonstrates promising clinical activity in metastatic HER2 positive breast cancer patients. Cancer Res.76(Suppl. 4), P4-13-19 (2016).
   Google Scholar
• Park YH , LeeKH, SohnJet al. A phase II trial of pan-HER inhibitor poziotinib, in patients with HER2+ metastatic breast cancer who have received at least two prior HER2-directed regimens: the results of NOV120101-203 trial. Ann. Oncol.28, v74 (2017).
   Web of Science ®Google Scholar
• Park YH , LeeKH, SohnJHet al. A phase II trial of the pan-HER inhibitor poziotinib, in patients with HER2+ metastatic breast cancer who had received at least two prior HER2-directed regimens: results of the NOV120101-203 trial. Int. J. Cancer143(12), 3240–3247 (2018).
   PubMed Web of Science ®Google Scholar
• Kim J-Y , LeeE, ParkKet al. Molecular alterations and poziotinib efficacy, a pan-HER inhibitor, in human epidermal growth factor receptor 2 (HER2)-positive breast cancers: combined exploratory biomarker analysis from a phase II clinical trial of poziotinib for refractory HER2+ breast cancer patients. Int. J. Cancer145(6), 1669–1678 (2019).
   PubMed Web of Science ®Google Scholar
• Xu B , YanM, MaFet al. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2+ metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol.22(3), 351–360 (2021).
   PubMed Web of Science ®Google Scholar
• Aftimos P , Van HerpenC, MommersEet al. Abstract P6-12-02: SYD985, a novel anti-HER2 ADC, shows promising activity in patients with HER2+ and HER2-negative metastatic breast cancer. Cancer Res.77(Suppl. 4), P6-12-02 (2017).
   Google Scholar
• Saura C , ThistlethwaiteF, BanerjiUet al. A phase I expansion cohorts study of SYD985 in heavily pretreated patients with HER2+ or HER2-low metastatic breast cancer. J. Clin. Oncol.36(Suppl. 15), 1014 (2018).
   Web of Science ®Google Scholar
• Ogitani Y , HagiharaK, OitateM, NaitoH, AgatsumaT. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody–drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci.107(7), 1039–1046 (2016).
   PubMed Web of Science ®Google Scholar
• Tsurutani J , IwataH, KropIet al. Targeting HER2 with trastuzumab deruxtecan: a dose-expansion, phase i study in multiple advanced solid tumors. Cancer Discov.10(5), 688–701 (2020).
   PubMed Web of Science ®Google Scholar
• Nguyen X , HooperM, BorlagdanJP, PalumboA. A review of fam-trastuzumab deruxtecan-nxki in HER2+ breast cancer. Ann. Pharmacother.55(11), 1410–1418 (2021).
   PubMed Web of Science ®Google Scholar
• Ogitani Y , AidaT, HagiharaKet al. DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin. Cancer Res.22(20), 5097–5108 (2016).
   PubMed Web of Science ®Google Scholar
• Rinnerthaler G , GampenriederSP, GreilR. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer. Int. J. Mol. Sci.20(5), 5 (2019).
   Web of Science ®Google Scholar
• Nakada T , SugiharaK, JikohT, AbeY, AgatsumaT. The latest research and development into the antibody-drug conjugate, [fam-] trastuzumab deruxtecan (DS-8201a), for HER2 cancer therapy. Chem. Pharm. Bull (Tokyo)67(3), 173–185 (2019).
   PubMed Web of Science ®Google Scholar
• Poon KA , FlagellaK, BeyerJet al. Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Toxicol. Appl. Pharmacol.273(2), 298–313 (2013).
   PubMed Web of Science ®Google Scholar
• Doi T , ShitaraK, NaitoYet al. Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody–drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study. Lancet Oncol.18(11), 1512–1522 (2017).
   PubMed Web of Science ®Google Scholar
• Nagai Y , OitateM, ShiozawaH, AndoO. Comprehensive preclinical pharmacokinetic evaluations of trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody–drug conjugate, in cynomolgus monkeys. Xenobiotica49(9), 1086–1096 (2019).
   PubMed Web of Science ®Google Scholar
• Andrikopoulou A , ZografosE, LiontosM, KoutsoukosK, DimopoulosMA, ZagouriF. Trastuzumab deruxtecan (DS-8201a): the latest research and advances in breast cancer. Clin. Breast Cancer21(3), e212–e219 (2021).
   PubMed Web of Science ®Google Scholar
• Tamura K , TsurutaniJ, TakahashiSet al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2+ breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol.20(6), 816–826 (2019).
   PubMed Web of Science ®Google Scholar
• Mckenzie JA , MbofungRM, MaluSet al. The effect of topoisomerase I inhibitors on the efficacy of T-cell-based cancer immunotherapy. J. Natl Cancer Inst.110(7), 777–786 (2018).
   PubMedGoogle Scholar
• Hamilton E , ShapiroCL, PetrylakDet al. Abstract PD3-07: trastuzumab deruxtecan (T-DXd; DS-8201) with nivolumab in patients with HER2-expressing, advanced breast cancer: a 2-part, phase 1b, multicenter, open-label study. Cancer Res.81(Suppl. 4), PD3-07–PD03-07 (2021).
   Web of Science ®Google Scholar
• Modi S , SauraC, YamashitaTet al. Trastuzumab deruxtecan in previously treated HER2+ breast cancer. N. Engl. J. Med.382(7), 610–621 (2020).
   PubMed Web of Science ®Google Scholar
• Takahashi S , ModiS, TsurutaniJet al. Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2+ breast cancer. Ann. Oncol.30, vi84 (2019).
   Web of Science ®Google Scholar
• Modi S , SauraC, YamashitaTet al. Abstract PD3-06: updated results from DESTINY-breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer. Cancer Res.81(Suppl. 4), PD3-06–PD03-06 (2021).
   Web of Science ®Google Scholar
• Jerusalem GHM , ParkYH, YamashitaTet al. Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: a subgroup analysis of the DESTINY-Breast01 trial. J. Clin. Oncol.39(Suppl. 15), 526 (2021).
   Web of Science ®Google Scholar
• Jerusalem G , ParkYH, YamashitaTet al. 138O CNS metastases in HER2+ metastatic breast cancer treated with trastuzumab deruxtecan: DESTINY-Breast01 subgroup analyses. Ann. Oncol.31, S63–S64 (2020).
   Web of Science ®Google Scholar
• Shitara K , IwataH, TakahashiSet al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2+ gastric cancer: a dose-expansion, phase 1 study. Lancet Oncol.20(6), 827–836 (2019).
   PubMed Web of Science ®Google Scholar
• Shitara K , BangY-J, IwasaSet al. Trastuzumab deruxtecan in previously treated HER2+ gastric cancer. N. Engl. J. Med.382(25), 2419–2430 (2020).
   PubMed Web of Science ®Google Scholar
• Tsurutani J , IwataH, KropIet al. Targeting HER2 with trastuzumab deruxtecan: a dose-expansion, phase I study in multiple advanced solid tumors. Cancer Discovery10(5), 688–701 (2020).
   PubMed Web of Science ®Google Scholar
• DS8201a and pembrolizumab in participants with locally advanced/metastatic breast or non-small cell lung cancer (2021). https://clinicaltrials.gov/ct2/show/NCT04042701
   Google Scholar
• A study of novel anti-cancer agents in patients with metastatic triple negative breast cancer (BEGONIA) (2021). https://clinicaltrials.gov/ct2/show/NCT03742102
   Google Scholar
• Hackshaw MD , DanyshHE, SinghJet al. Incidence of pneumonitis/interstitial lung disease induced by HER2-targeting therapy for HER2+ metastatic breast cancer. Breast Cancer Res. Treat.183(1), 23–39 (2020).
   PubMed Web of Science ®Google Scholar
• Kumagai K , AidaT, TsuchiyaY, KishinoY, KaiK, MoriK. Interstitial pneumonitis related to trastuzumab deruxtecan, a human epidermal growth factor receptor 2-targeting Ab-drug conjugate, in monkeys. Cancer Sci.111(12), 4636–4645 (2020).
   PubMed Web of Science ®Google Scholar
• Fehrenbacher L , CecchiniRS, GeyerCEJret al. NSABP B-47/NRG oncology phase III randomized trial comparing adjuvant chemotherapy with or without trastuzumab in high-risk invasive breast cancer negative for HER2 by FISH and with IHC 1+ or 2. J. Clin. Oncol.38(5), 444–453 (2020).
   PubMed Web of Science ®Google Scholar
• Gianni L , LladóA, BianchiGet al. Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer. J. Clin. Oncol.28(7), 1131–1137 (2010).
   PubMed Web of Science ®Google Scholar
• Yazaki S , HashimotoJ, OgitaS, NakanoE, YamauchiT. Lower response to T-DM1 in metastatic breast cancer patients with HER2 IHC score of 2 and FISH positive compared with IHC score of 3. Ann. Oncol.28, v102–v103 (2017).
   Google Scholar
• Brufsky A , ZulfiqarM, PegueroJ, LathropK, BhatG, LebelF. Abstract PD1-07: a phase 2 study of poziotinib in patients with HER2+ metastatic breast cancer heavily pre-treated with HER2-targeted therapy. Cancer Res.81(Suppl. 4), PD1-07–PD01-07 (2021).
   Web of Science ®Google Scholar
• A phase 1b study of T-DXd combinations in HER2-low advanced or metastatic breast cancer (DB-08) (2021). https://clinicaltrials.gov/ct2/show/NCT04556773
   Google Scholar
• Trastuzumab deruxtecan in participants with HER2-mutated metastatic non-small cell lung cancer (NSCLC) (DESTINY-LUNG02) (2021). https://clinicaltrials.gov/ct2/show/NCT04644237?term=trastuzumab+deruxtecan&draw=2&rank=1
   Google Scholar
• Trastuzumab deruxtecan for subjects with HER2+ gastric cancer or gastro-esophageal junction adenocarcinoma after progression on or after a trastuzumab-containing regimen (DESTINY-Gastric04). (2021) https://clinicaltrials.gov/ct2/show/NCT04704934?term=trastuzumab+deruxtecan&draw=2&rank=3
   Google Scholar
• Trastuzumab deruxtecan in participants with HER2-overexpressing advanced or metastatic colorectal cancer (DESTINY-CRC02) (2021). https://clinicaltrials.gov/ct2/show/NCT04744831?term=trastuzumab+deruxtecan&draw=3&rank=13
   Google Scholar
• Trastuzumab deruxtecan for the treatment of HER2+ newly diagnosed or recurrent osteosarcoma (2021). https://clinicaltrials.gov/ct2/show/NCT04616560?term=trastuzumab+deruxtecan&draw=2&rank=8
   Google Scholar
• A phase 1b/2 study of T-DXd combinations in HER2+ metastatic breast cancer (DB-07) (2021). https://clinicaltrials.gov/ct2/show/NCT04538742
   Google Scholar
• Trastuzumab deruxtecan alone or in combination with anastrozole for the treatment of early stage HER2 low, hormone receptor positive breast cancer (2021). https://clinicaltrials.gov/ct2/show/NCT04553770
   Google Scholar
• Trastuzumab deruxtecan (T-DXd) with or without pertuzumab versus taxane, trastuzumab and pertuzumab in HER2+ metastatic breast cancer (DESTINY-Breast09) (2021). https://clinicaltrials.gov/ct2/show/NCT04784715
   Google Scholar
• Andre F , HamiltonEP, LoiSet al. Trastuzumab deruxtecan (T-DXd) combinations in patients with HER2+ advanced or metastatic breast cancer: a phase 1b/2, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07). J. Clin. Oncol.39(Suppl. 15), TPS1096–TPS1096 (2021).
   Web of Science ®Google Scholar
• DS-8201a for treatment of aBc, BRain Mets, and Her2[+] disease (DEBBRAH) (2021). https://clinicaltrials.gov/ct2/show/NCT04420598?term=trastuzumab+deruxtecan&draw=3&rank=15
   Google Scholar
• FDA approves fam-trastuzumab deruxtecan-nxki for HER2+ gastric adenocarcinomas (2021). www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas
   Google Scholar
• DS-8201a in pre-treated HER2 breast cancer that cannot be surgically removed or has spread [DESTINY-Breast02] (2021). www.clinicaltrials.gov/ct2/show/NCT03523585
   Google Scholar
• DS-8201a versus T-DM1 for human epidermal growth factor receptor 2 (HER2)-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and taxane [DESTINY-Breast03] (2021) https://www.clinicaltrials.gov/ct2/show/NCT03529110
   Google Scholar
• Trastuzumab deruxtecan (DS-8201a) versus investigator's choice for HER2-low breast cancer that has spread or cannot be surgically removed [DESTINY-Breast04] (2021). https://clinicaltrials.gov/ct2/show/NCT03734029
   Google Scholar
• A study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in high-risk HER2+ participants with residual invasive breast cancer following neoadjuvant therapy (DESTINY-Breast05) (2021). https://clinicaltrials.gov/ct2/show/NCT04622319
   Google Scholar
• Study of trastuzumab deruxtecan (T-DXd) vs investigator's choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer (DB-06) (2021). https://clinicaltrials.gov/ct2/show/NCT04494425
   Google Scholar
• A study of tucatinib plus trastuzumab deruxtecan in HER2+ breast cancer (HER2CLIMB-04) (2021). https://clinicaltrials.gov/ct2/show/NCT04539938
   Google Scholar