Antibody-drug conjugates: Smart chemotherapy delivery across tumor histologies.
antibody-drug conjugates
enfortumab vedotin
histology-agnostic
sacituzumab govitecan
smart chemotherapy
trastuzumab deruxtecan
Journal
CA: a cancer journal for clinicians
ISSN: 1542-4863
Titre abrégé: CA Cancer J Clin
Pays: United States
ID NLM: 0370647
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
revised:
26
09
2021
received:
07
07
2021
accepted:
04
10
2021
pubmed:
13
11
2021
medline:
6
5
2022
entrez:
12
11
2021
Statut:
ppublish
Résumé
As distinct cancer biomarkers have been discovered in recent years, a need to reclassify tumors by more than their histology has been proposed, and therapies are now tailored to treat cancers based on specific molecular aberrations and immunologic markers. In fact, multiple histology-agnostic therapies are currently adopted in clinical practice for treating patients regardless of their tumor site of origin. In parallel with this new model for drug development, in the past few years, several novel antibody-drug conjugates (ADCs) have been approved to treat solid tumors, benefiting from engineering improvements in the conjugation process and the introduction of novel linkers and payloads. With the recognition that numerous surface targets are expressed across various cancer histologies, alongside the remarkable activity of modern ADCs, this drug class has been increasingly evaluated as suitable for a histology-agnostic expansion of indication. For illustration, the anti-HER2 ADC trastuzumab deruxtecan has demonstrated compelling activity in HER2-overexpressing breast, gastric, colorectal, and lung cancer. Examples of additional novel and potentially histology-agnostic ADC targets include trophoblast cell-surface antigen 2 (Trop-2) and nectin-4, among others. In the current review article, the authors summarize the current approvals of ADCs by the US Food and Drug Administration focusing on solid tumors and discuss the challenges and opportunities posed by the multihistological expansion of ADCs.
Substances chimiques
Antineoplastic Agents
0
Immunoconjugates
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
165-182Informations de copyright
© 2021 The Authors. CA: A Cancer Journal for Clinicians published by Wiley Periodicals LLC on behalf of American Cancer Society.
Références
DeVita VT, Rosenberg SA. Two hundred years of cancer research. N Engl J Med. 2012;366:2207-2214.
Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature. 2011;480:480-489.
Kimmelman J, Tannock I. The paradox of precision medicine. Nat Rev Clin Oncol. 2018;15:341-342.
Pestana RC, Sen S, Hobbs BP, Hong DS. Histology-agnostic drug development-considering issues beyond the tissue. Nat Rev Clin Oncol. 2020;17:555-568.
Hong DS, DuBois SG, Kummar S, et al. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020;21:531-540.
Doebele RC, Drilon A, Paz-Ares L, et al. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21:271-282.
Marabelle A, Fakih M, Lopez J, et al. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020;21:1353-1365.
Marabelle A, Le DT, Ascierto PA, et al. Efficacy of pembrolizumab in patients with noncolorectal high microsatellite instability/mismatch repair-deficient cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2020;38:1-10.
Tarantino P, Mazzarella L, Marra A, Trapani D, Curigliano G. The evolving paradigm of biomarker actionability: histology-agnosticism as a spectrum, rather than a binary quality. Cancer Treat Rev. 2021;94:102169.
Drago JZ, Modi S, Chandarlapaty S. Unlocking the potential of antibody-drug conjugates for cancer therapy. Nat Rev Clin Oncol. 2021;18:327-344.
Strebhardt K, Ullrich A. Paul Ehrlich's magic bullet concept: 100 years of progress. Nat Rev Cancer. 2008;8:473-480.
Beck A, Goetsch L, Dumontet C, Corvaoa N. Strategies and challenges for the next generation of antibody-drug conjugates. Nat Rev Drug Discov. 2017;16:315-337.
Saleh MN, Sugarman S, Murray J, et al. Phase I trial of the anti-Lewis Y drug immunoconjugate BR96-doxorubicin in patients with Lewis Y-expressing epithelial tumors. J Clin Oncol. 2000;18:2282-2292.
Elias DJ, Hirschowitz L, Kline LE, et al. Phase I clinical comparative study of monoclonal antibody KS1/4 and KS1/4-methotrexate immunconjugate in patients with non-small cell lung carcinoma. Cancer Res. 1990;50:4154-4159.
Baron J, Wang ES. Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia. Expert Rev Clin Pharmacol. 2018;11:549-559.
Richardson MC, Kasamon YL, Chen H, et al. FDA approval summary: brentuximab vedotin in first-line treatment of peripheral T-cell lymphoma. Oncologist. 2019;24:e180-e187.
Amiri-Kordestani L, Blumenthal GM, Xu QC, et al. FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer. Clin Cancer Res. 2014;20:4436-4441.
Slamon DK, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712.
Slamon D, Leyland-Jones B, Shak H, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783-792.
Tarantino P, Prat A, Cortes J, Cardoso F, Curigliano G. Third-line treatment of HER2-positive advanced breast cancer: from no standard to a Pandora's box. Biochim Biophys Acta Rev Cancer. 2021;1875:188487.
Tarantino P, Morganti S, Curigliano G. Targeting HER2 in breast cancer: new drugs and paradigms on the horizon. Explor Target Antitumor Ther. 2021;2:139-155.
Phillips GDL, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68:9280-9291.
Verma S, David M, Luca G, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367:1783-1791.
Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31:1623-1649.
Del Prete S, Montella L, Arpino G, et al. Second line trastuzumab emtansine following horizontal dual blockade in a real-life setting. Oncotarget. 2020;11:2083-2091.
von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380:617-628.
Mamounas EP, Untch M, Mano MS, et al. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Ann Oncol. 2021;32:1005-1014.
Narayan P, Osgood CL, Singh H, et al. FDA approval summary: fam-trastuzumab deruxtecan-nxki for the treatment of unresectable or metastatic HER2-positive breast cancer. Clin Cancer Res. 2021;27:4478-4485.
Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med. 2020;382:610-621.
Modi S, Saura C, Yamashita T, et al. Updated results from DESTINY-Breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer [abstract]. Cancer Res. 2021;81(4 suppl):PD3-06.
Suzuki M, Yagishita S, Sugihara K, et al. Visualization of intratumor pharmacokinetics of [fam-] trastuzumab deruxtecan (DS-8201a) in HER2 heterogeneous model using phosphor-integrated dots imaging analysis. Clin Cancer Res. 2021;27:3970-3979.
Cortes J, Kim SB, Chung WP, et al. LBA1 Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (Pts) with HER2+ metastatic breast cancer (mBC): results of the randomized phase III DESTINY-Breast03 study [abstract]. Ann Oncol. 2021;32(suppl 5):S1287-S1288.
Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015;18:476-484.
Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376:687-697.
Tabernero J, Hoff PM, Shen L, et al. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018;19:1372-1384.
Joshi SS, Badgwell BD. Current treatment and recent progress in gastric cancer. CA Cancer J Clin. 2021;71:264-279.
Mitani S, Kawakami H. Emerging targeted therapies for HER2 positive gastric cancer that can overcome trastuzumab resistance. Cancers (Basel). 2020;12:400.
Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med. 2020;382:2419-2430.
US Food and Drug Administration (FDA). FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. FDA; 2021. Accessed October 18, 2021. fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas
Yamaguchi K, Bang YJ, Iwasa S, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01) [abstract]. J Clin Oncol. 2021;39(15 suppl):4048.
Bianchini G, Balko JM, Mayer IA, Sanders ME, Gianni L. Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease. Nat Rev Clin Oncol. 2016;13:674-690.
Sharkey RM, McBride WJ, Cardillo TM, et al. Enhanced delivery of SN-38 to human tumor xenografts with an anti-Trop-2-SN-38 antibody conjugate (sacituzumab govitecan). Clin Cancer Res. 2015;21:5131-5138.
Starodub AN, Ocean AJ, Shah MA, et al. First-in-human trial of a novel anti-Trop-2 antibody-SN-38 conjugate, sacituzumab govitecan, for the treatment of diverse metastatic solid tumors. Clin Cancer Res. 2015;21:3870-3878.
Trerotola M, Cantanelli P, Guerra E, et al. Upregulation of Trop-2 quantitatively stimulates human cancer growth. Oncogene. 2013;32:222-233.
Ambrogi F, Fornili M, Boracchi P, et al. Trop-2 is a determinant of breast cancer survival. PLoS One. 2014;9:e96993.
Perrone E, Lopez S, Zeybek B, et al. Preclinical activity of sacituzumab govitecan, an antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (Trop-2) linked to the active metabolite of irinotecan (SN-38), in ovarian cancer. Front Oncol. 2020;10:118.
Wahby S, Fashoyin-Aje L, Osgood CL, et al. FDA approval summary: accelerated approval of sacituzumab govitecan-hziy for third-line treatment of metastatic triple-negative breast cancer. Clin Cancer Res. 2021;27:1850-1854.
Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384:1529-1541.
Milowsky MI, Rumble RB, Booth CM, et al. Guideline on muscle-invasive and metastatic bladder cancer (European Association of Urology guideline): American Society of Clinical Oncology clinical practice guideline endorsement. J Clin Oncol. 2016;34:1945-1952.
US Food and Drug Administration (FDA). FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. FDA; 2021. Accessed October 18, 2021. fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer
Chang E, Weinstock C, Zhang L, et al. FDA approval summary: enfortumab vedotin for locally advanced or metastatic urothelial carcinoma. Clin Cancer Res. 2021;27:922-927.
McGregor BA, Sonpavde G. Enfortumab vedotin, a fully human monoclonal antibody against nectin 4 conjugated to monomethyl auristatin E for metastatic urothelial carcinoma. Expert Opin Investig Drugs. 2019;28:821-826.
Liu BA, Olson D, Snead K, et al. Enfortumab vedotin, an anti-nectin-4 ADC demonstrates bystander cell killing and immunogenic cell death anti-tumor activity mechanisms of action in urothelial cancers [abstract]. Cancer Res. 2020;80(15 suppl):5581.
Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384:1125-1135.
Bruce JY, Pusztai L, Braiteh FS, Gorla SR, Wu C, Baranda J. EV-202: a phase II study of enfortumab vedotin in patients with select previously treated locally advanced or metastatic solid tumors [abstract]. J Clin Oncol. 2020;38(15 suppl):TPS3647.
Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39:2474-2485.
Muhlmann G, Spizzo G, Gostner J, et al. TROP2 expression as prognostic marker for gastric carcinoma. J Clin Pathol. 2009;62:152-158.
Ohmachi T, Tanaka F, Mimori K, Inoue H, Yanaga K, Mori M. Clinical significance of TROP2 expression in colorectal cancer. Clin Cancer Res. 2006;12:3057-3063.
Fong D, Spizzo G, Gostner JM, et al. TROP2: a novel prognostic marker in squamous cell carcinoma of the oral cavity. Mod Pathol. 2008;21:186-191.
Avellini C, Licini C, Lazzarini R, et al. The trophoblast cell surface antigen 2 and miR-125b axis in urothelial bladder cancer. Oncotarget. 2017;8:58642-58653.
Coleman RL, Lorusso D, Gennigens C, et al. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22(5):609-619. doi:10.1016/S1470-2045(21)00056-5
Siena S, Di Bartolomeo M, Raghav K, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021;22:779-789.
Li BY, Smit EF, Goto Y, et al. Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer. N Engl J Med. Published online September 18, 2021. doi:10.1056/NEJMoa2112431
Bardia A, Messersmith WA, Kio EA, et al. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. Ann Oncol. 2021;32:746-756.
Banerji U, van Herpen CML, Saura C, et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2019;20:1124-1135.
Oh DY, Bang YJ. HER2-targeted therapies-a role beyond breast cancer. Nat Rev Clin Oncol. 2020;17:33-48.
Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76:3003-3013.
Thuss-Patience PC, Shah MA, Ohtsu A, et al. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017;18:640-653.
Jhaveri KL, Wang XV, Makker V, et al. Ado-trastuzumab emtansine (T-DM1) in patients with HER2-amplified tumors excluding breast and gastric/gastroesophageal junction (GEJ) adenocarcinomas: results from the NCI-MATCH trial (EAY131) subprotocol Q. Ann Oncol. 2019;30:1821-1830.
Jhaveri KL, Makker V, Wang XV, et al. Ado-trastuzumab emtansine (T-DM1) in patients (pts) with HER2 amplified (amp) tumors excluding breast and gastric/gastro-esophageal junction (GEJ) adenocarcinomas: results from the National Cancer Institute (NCI) Molecular Analysis for Therapy Choice (MATCH) trial [abstract]. J Clin Oncol. 2018;36(15 suppl):100.
Sartore-Bianchi A, Lonardi S, Martino C, et al. Pertuzumab and trastuzumab emtansine in patients with HER2-amplified metastatic colorectal cancer: the phase II HERACLES-B trial. ESMO Open. 2020;5:e000911.
Li BT, Shen R, Buonocore D, et al. Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial. J Clin Oncol. 2018;36:2532-2537.
Nakagawa K, Nagasaka M, Felip E, et al. OA04.05 Trastuzumab deruxtecan in HER2-overexpressing metastatic non-small cell lung cancer: interim results of DESTINY-Lung01. J Thorac Oncol. 2021;16(3 suppl):S109-S110.
Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol. 2020;38:1951-1962.
Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ib study. J Clin Oncol. 2020;38:1887-1896.
Yamaguchi K, Bang YJ, Iwasa S, et al. 1422MO Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-low, advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: results of the exploratory cohorts in the phase II, multicenter, open-label DESTINY-Gastric01 study [abstract]. Ann Oncol. 2020;31(suppl 4):S899-S900.
van Der Lee MMC, Groothuis PG, Ubink R, et al. The preclinical profile of the duocarmycin-based HER2-targeting ADC SYD985 predicts for clinical benefit in low HER2-expressing breast cancers. Mol Cancer Ther. 2015;14:692-703.
Saura Manich C, O’Shaughnessy J, Aftimos PG, et al. LBA15 Primary outcome of the phase III TULIP trial comparing [vic]trastuzumab duocarmazine to physician's choice treatment in patients with pre-treated HER2-positive locally advanced or metastatic breast cancer [abstract]. Ann Oncol. 2021;32(suppl 5):S1288.
Li L, Xu MZ, Wang L, et al. Conjugating MMAE to a novel anti-HER2 antibody for selective targeted delivery. Eur Rev Med Pharmacol Sci. 2021;25:12929-12937.
Xu B, Wang J, Fang J, et al. Abstract PD4-06: Early clinical development of RC48-ADC in patients with HER2 positive metastatic breast cancer [abstract]. Cancer Res. 2020;80(4 suppl):PD4-06.
Peng Z, Liu T, Wei J, et al. A phase II study of efficacy and safety of RC48-ADC in patients with locally advanced or metastatic HER2-overexpressing gastric or gastroesophageal junction cancers [abstract]. J Clin Oncol. 2020;38(15 suppl):4560.
Sheng X, Yan X, Wang L, et al. Open-label, multicenter, phase II study of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with locally advanced or metastatic urothelial carcinoma. Clin Cancer Res. 2021;27:43-51.
Koshkin VS, O’Donnell P, Yu EY, Grivas P. Systematic review: targeting HER2 in bladder cancer. Bladder Cancer. 2019;5:1-12.
Wang J, Liu Y, Zhang Q, et al. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: a pooled analysis of two studies [abstract]. J Clin Oncol. 2021;39(15 suppl):1022.
Rapani E, Sacchetti A, Corda D, Alberti S. Human TROP-2 is a tumor-associated calcium signal transducer. Int J Cancer. 1998;76:671-676.
Kalinsky K, Diamond JR, Vahdat LT, et al. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.
Spira A, Lisberg A, Sands J, et al. OA03.03 Datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 ADC, in patients with advanced NSCLC: updated results of TROPION-PanTumor01 phase 1 study. J Thorac Oncol. 2021;16(3 suppl):S106-S107.
Bardia A, Juric D, Shimizu T, et al. LBA4 Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC), for triple-negative breast cancer (TNBC): preliminary results from an ongoing phase I trial [abstract]. Ann Oncol. 2021;32(suppl 2):S60-S78.
Meric-Bernstam F, Spira AI, Lisberg AE, et al. TROPION-PanTumor01: dose analysis of the TROP2-directed antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd, DS-1062) for the treatment (Tx) of advanced or metastatic non-small cell lung cancer (NSCLC) [abstract]. J Clin Oncol. 2021;39(15 suppl):9058.
Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009;101:708-720.
Schneck D, Butler F, Dugan W, et al. Disposition of a murine monoclonal antibody vinca conjugate (KS 1/4-DAVLB) in patients with adenocarcinomas. Clin Pharmacol Ther. 1990;47:36-41.
Press MF, Slamon DJ, Flom KJ, Park J, Zhou JY, Bernstein L. Evaluation of HER-2/neu gene amplification and overexpression: comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens. J Clin Oncol. 2002;20:3095-3105.
Peters S, Stahel R, Bubendorf L, et al. Trastuzumab emtansine (T-DM1) in patients with previously treated HER2-overexpressing metastatic non-small cell lung cancer: efficacy, safety, and biomarkers. Clin Cancer Res. 2019;25:64-72.
Krop IE, Beeram M, Modi S, et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol. 2010;28:2698-2704.
Burris HA, Rugo HS, Vukelja SJ, et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol. 2010;29:398-405.
Wolff AC, McShane LM, Hammond MEH, et 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. Arch Pathol Lab Med. 2018;142:1364-1382.
Li BT, Michelini F, Misale S, et al. HER2-mediated internalization of cytotoxic agents in ERBB2 amplified or mutant lung cancers. Cancer Discov. 2020;10:674-687.
Bardia A, Tolaney SM, Punie K, et al. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. Ann Oncol. 2021;32:1148-1156.
Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015;6:22496-22512.
Sayama Y, Kaneko M, Kato Y. Development and characterization of TrMab-6, a novel anti-TROP2 monoclonal antibody for antigen detection in breast cancer. Mol Med Rep. 2020;23:92.
Sayama Y, Kaneko MK, Takei J, et al. Establishment of a novel anti-TROP2 monoclonal antibody TrMab-29 for immunohistochemical analysis. Biochem Biophys Rep. 2021;25:100902.
Chu CE, Sjostrom M, Egusa EA, et al. Heterogeneity in NECTIN4 expression across molecular subtypes of urothelial cancer mediates sensitivity to enfortumab vedotin. Clin Cancer Res. 2021;27:5123-5130.
Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol. 2012;69:1229-1240.
Doi T, Shitara K, Naito Y, et 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. 2017;18:1512-1522.
Ocean AJ, Starodub AN, Bardia A, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: safety and pharmacokinetics. Cancer. 2017;123:3843-3854.
Rugo HS, Tolaney SM, Loirat D, et al. Abstract PS11-09: Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer [abstract]. Cancer Res. 2021;81(4 suppl):PS11-09.
Venditto VJ, Simanek EE. Cancer therapies utilizing the camptothecins: a review of the in vivo literature. Mol Pharm. 2010;7:307-349.
Kumagai K, Aida T, Tsuchiya Y, Kishino Y, Kai K, Mori K. Interstitial pneumonitis related to trastuzumab deruxtecan, a human epidermal growth factor receptor 2-targeting Ab-drug conjugate, in monkeys. Cancer Sci. 2020;111:4636-4645.
Nishino M, Giobbie-Hurder A, Hatabu H, Ramaiya NH, Hodi FS. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer. JAMA Oncol. 2016;2:1607.
Smit EF, Nakagawa K, Nagasaka M, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC): interim results of DESTINY-Lung01 [abstract]. J Clin Oncol. 2020;38(15 suppl):9504.
Takahashi S, Modi S, Tsurutani J, et al. Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer [abstract]. Ann Oncol. 2019;30(suppl 6):vi84.
Schoenfeld AJ, Arbour KC, Rizvi H, et al. Severe immune-related adverse events are common with sequential PD-(L)1 blockade and osimertinib. Ann Oncol. 2019;30:839-844.
Oshima Y, Tanimoto T, Yuji K, Tojo A. EGFR-TKI-associated interstitial pneumonitis in nivolumab-treated patients with non-small cell lung cancer. JAMA Oncol. 2018;4:1112.
Lin JJ, Chin E, Yeap EY, et al. Increased hepatotoxicity associated with sequential immune checkpoint inhibitor and crizotinib therapy in patients with non-small cell lung cancer. J Thorac Oncol. 2019;14:135-140.
Schettini F, Barbao P, Braso-Maristany F, et al. Identification of cell surface targets for CAR-T cell therapies and antibody-drug conjugates in breast cancer. ESMO Open. 2021;6:100102.
Fauteux F, Hill JJ, Jaramillo ML, et al. Computational selection of antibody-drug conjugate targets for breast cancer. Oncotarget. 2016;7:2555-2571.
Subbiah V, Erwin W, Mawlawi P, et al. Phase I study of P-cadherin-targeted radioimmunotherapy with 90 Y-FF-21101 monoclonal antibody in solid tumors. Clin Cancer Res. 2020;26:5830-5842.
Dumbrava EI, Sharma MR, Carvajal RD, et al. Abstract OT-03-02: Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors. Paper presented at: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas.
Yamazaki CM, Yamaguchi A, Anami Y, et al. Antibody-drug conjugates with dual payloads for combating breast tumor heterogeneity and drug resistance. Nat Commun. 2021;12:3528.
Oh DY, Hamilton E, Hanna D, et al. Safety, anti-tumour activity, and biomarker results of the HER2-targeted bispecific antibody ZW25 in HER2-expressing solid tumours [abstract]. Ann Oncol. 2019;30(suppl 9):ix22.
Meric-Bernstam F, Hamilton EP, Beeram M, et al. Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA): results from a phase I study [abstract]. J Clin Oncol. 2021;39(3 suppl):164.
Meric-Bernstam F, Hanna DL, El-Khoueiry AB, et al. Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): results from a phase I study [abstract]. J Clin Oncol. 2021;39(3 suppl):299.
Hamblett K, Barnscher S, Davies R, et al. Abstract 3914: ZW49, a HER2-targeted biparatopic antibody-drug conjugate for the treatment of HER2-expressing cancers. Cancer Res. 2018;78(13 suppl):3914.
Bauzon M, Drake PM, Barfield RM, Cornali BM, Rupniewski I, Rabuka D. Maytansine-bearing antibody-drug conjugates induce in vitro hallmarks of immunogenic cell death selectively in antigen-positive target cells. Oncoimmunology. 2019;8:e1565859.
Scaltriti M, Verma C, Guzman M, et al. Lapatinib, a HER2 tyrosine kinase inhibitor, induces stabilization and accumulation of HER2 and potentiates trastuzumab-dependent cell cytotoxicity. Oncogene. 2009;28:803-814.