Therapeutic Potential of Antibody-Drug Conjugate-Based Therapy in Head and Neck Cancer: A Systematic Review
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Search Strategy
2.2. Eligibility Criteria
2.2.1. Inclusion Criteria
2.2.2. Exclusion Criteria
2.3. Focused PICO Question
2.4. Selection of Studies
2.5. Data Extraction and Method of Analysis
2.6. Risk of Bias Assessment
2.7. Statistical Analysis
3. Results
3.1. Study Characteristics
3.2. Risk of Bias
3.3. Preclinical Studies
Anderson et al., 2020
Gymnopoulos et al., 2020
Scribner et al., 2020
Ghanemi et al., 2018
Purcell et al., 2018
Theunissen et al., 2018
Wong et al., 2018
Kerk et al., 2017
Strop et al., 2016
Sweeny et al., 2013
Chen et al., 2012
Osterman et al., 2008
Herbert et al., 2003
3.4. Clinical Studies
Cleary et al., 2020
Tsurutani et al., 2020
de Bono et al., 2019
Ocean et al., 2017
Riechelmann et al., 2008
Sauter et al., 2006
3.5. Clinical Trials
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Study | Reasons for Exclusion |
---|---|
Seok et al., 2020 [83] | Anaplastic thyroid carcinoma |
Sunavala-Dossabhoy et al., 2020 [85] | Invited commentary |
Takei et al., 2020 [86] | mAb |
Bera et al., 2019 [72] | Thyroid peroxidase (TPO)-mesothelin (MSLN) mouse model development and antitumor efficacy of LMB-100 (hMSLN-targeted immunotoxin) and anti-CTLA-4 (cytotoxic T-lymphocyte antigen 4) |
Mao et al., 2018 [79] | Photodynamic therapy |
Zhang et al., 2018 [90] | Near-infrared photoimmunotherapy using gold nanoparticles (AuNPs) conjugated with a mAb targeting the EGFR |
Benedetto et al., 2017 [71] | 111In-DTPA-cetuximab radioimmunoconjugate preparation |
Jang et al., 2017 [75] | Study performed on patients with thyroid cancers |
Munasinghe et al., 2017 [80] | Investigation on specific adverse effect on QT interval prolongation |
Nagaya et al., 2017 [81] | Near-infrared photoimmunotherapy using anti-CD44 monoclonal antibodies conjugated to the photoabsorber IR700DX |
Challita-Eid et al., 2016 [73] | Immunohistochemical expression of Nectin-4 |
vanDriel et al., 2016 [87] | Photodynamic therapy |
Lamberts et al., 2015 [77] | Expression of membrane-bound glycoprotein mesothelin (MSLN) by functional genomic mRNA profiling in 41 tumor types |
Bachran et al., 2013 [70] | Cytotoxicity of Bacillus anthracis lethal factor (LFn), N-terminal 389 aminoacids of diphtheria toxin (DT389) and human transforming growth factor alpha (TGFalpha) against EGFR-expressing cell line |
Zhang et al., 2013 [89] | Immunohistochemical expression of anti-latent membrane protein 1 (LMP1) in the treatment of advanced nasopharyngeal carcinoma (NPC) |
Sandstrom et al., 2011 [82] | (67Ga)Ga-NOTA-Bn-NCS-hEGF radioimmunoconjugate for the diagnostic imaging of EGFR-expressing tumors |
Maeda et al., 2009 [78] | Effect of sonoporation and anti-EGFR antibody as a drug-delivery system for treating squamous cell carcinoma |
El-Sayed et al., 2006 [74] | Photodynamic therapy |
Kawakami et al., 2004 [76] | Effect of nitric oxide (NO) inhibiter on IL-13-PE38QQR (Pseudomonas exotoxin) cytotoxin-mediated cytotoxicity |
Yamamoto et al., 2004 [88] | Actinobacillus actinomycetemcomitans cytolethal distending toxin (Cdt-B) |
Strome et al., 2002 [84] | IL--4R-PE38KDEL (Pseudomonas exotoxin) |
ADC | Target Antigen | Payload | Linker Type | Tumor Type (s) | Models | Company | References | Notes |
---|---|---|---|---|---|---|---|---|
Serclutamab talirine/ABBV-321 | EGFR | PBD dimer SGD-1882 with a fixed DAR of 2.0 | Cathepsin-cleavable maleimidocaproyl-valine-alanine (MC-Val-Ala) type linker | Colorectal cancer, glioblastoma, HNC, lung cancer, malignant mesothelioma | HNC cell lines: FaDu, A253 HNC PDX models: CTG-505, CTG-152, CTG-149, CTG-786, CTG-434 | AbbVie | Anderson 2020 [51] | NCT03234712—https://adc.expert/2MKZSp2 (accessed on May 16th, 2021) |
TR1801-ADC/MT-8633 | c-Met | PBD toxin-linker tesirine (SG3249) | Cleavable (Val-Ala) | Biliary tract cancer, colon cancer, gastric cancer, HNC, lung cancer | HNC cell lines: Detroit 562, FaDu. Ten HuPrime HNC PDX models, among three specified: HN3533; HN0635; HN0696 | Tanabe Research Laboratories USA in collaboration with Open Innovation Partners and MedImmune/AstraZeneca | Gymnopoulos 2020 [56] | TR1801-ADC in patients with tumors that express c-Met | https://clinicaltrials.gov/ct2/show/NCT03859752 (accessed on May 16th, 2021) |
MGC018; ANTI-B7-H3 ADC | B7-H3 (CD276) | Synthetic duocarmycin analogs | Cleavable valine-citrulline-seco duocarmycin hydroxy-benzamide azaindole (vc-seco-DUBA) | Breast cancer, HNC, lung cancer, melanoma, ovarian cancer | HNC PDX model: Not specified | MacroGenics, Inc. | Scribner 2020 [64] | |
Idarubicin-Z HER2:342 | HER 2 | Idarubicin | Cleavable | HNC | HNC cell lines: HN5 | // | Ghanemi 2018 [55] | |
Samrotamab vedotin/ABBV-085 | LRRC15 | MMAE | Protease cleavable Val-cit | Breast cancer, colorectal cancer, gastric cancer, glioblastoma, HNC, lung cancer, melanoma, osteosarcoma, ovarian cancer, pancreatic cancer, pleomorphic undifferentiated sarcoma, testicular cancer | HNC xenograft models: SCC15 | AbbVie. S.E., AbbVie. E.D. | Purcell 2018 [61] | NCT02565758—https://clinicaltrials.gov/ct2/show/NCT02565758 (accessed on May 16th, 2021) |
Anti-TF ADCs | TF (CD142) | MMAE | Cleavable | gastric cancer, HNC, ovarian cancer | HNC PDX models: not specified | Iconic Therapeutics, Inc. | Theunissen 2018 [67] | |
RN765C | EGFR | PF-06380101 (AUR0101) an auristatin microtubule inhibitor (a cytotoxic dolastatin 10 analogue) | AcLys-VC (valine-citruline)-PABC (cleavable linker) | Breast cancer, colorectal cancer, glioblastoma, HNC, lung cancer | HNC cell lines: FADu | Pfizer/Rinat | Wong 2018 [69] | |
MEDI0641 | 5T4 | PBD | Cleavable (dipeptide) | HNC | HNC cell lines: UM-SCC-11B, UM-SCC-22B, HNC PDX models: PDX-SCC-M0, PDX-SCC-M1, PDX-SCC-M11 | MedImmune LLC | Kerk 2017 [58] | |
RN927C | Trop-2 | PF-06380101 (AUR0101) an auristatin microtubule inhibitor (a cytotoxic Dolastatin 10 analogue) | Cleavable AcLys-VC-PABC | Breast cancer, colon cancer, HNC, lung cancer, ovarian cancer, pancreatic cancer, skin cancer | HNC cell lines: Fadu | Pfizer/Rinat | Strop 2016 [65] | |
EDC22 | CD147 | Na/K-ATPase inhibitor | Non cleavable heterobifunctional linker | HNC | HNC cell lines: FaDu, OSC-19, Cal27, SCC-1 HNC xenograft models: SCC-1HNC orthotopic models: OSC-19 | Centrose, LLC | Sweeny 2013 [66] | |
HLEAFab-MMC | LMP1 | Mytomicin C | Cleavable N-succinimidyl 3-(2-pyridyldithio) propionate (SPDP) | Nasopharyngeal cancer | HNC cell lines: HNE2 and HNE2/LMP1 transfected, HNC xenograft models: HNE2/LMP1 transfected | // | Chen 2012 [52] | |
FAP5-SPP-DM1, FAP5-SPDB-DM4, FAP5-SMCC-DM1 | FAPα | Maytansinoids DM1/DM4 | Cleavable SPP, Cleavable SPDB, Non cleavable SMCC | Colon cancer, fibrosarcoma, HNC, lung cancer, pancreatic cancer | HNC cell lines: FaDu HNC xenograft model: FaDu | ImmunoGen and Oncotest | Ostermann 2008 [60] | |
SPA470-doxorubicin | Hsp47/CBP2 | doxorubicin | Cleavable acylhydrazone linker | HNC | HNC cell lines: SCC-4, -9, -15 and -25; UMB2/Hsp47 transfected | // | Herbert 2003 [57] |
ADC | Target Antigen | Payload | Linker Type | Tumor Type(s) | Phase | Sample Size (Total/HNC) | Stage | Primary Outcomes | Secondary Outcomes | Sponsor/ Collaborator | References | Notes |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Losatuxizumab vedotin/ABBV-221 | EGFR | MMAE | Cleavable (Mc-Val-Cit-PABC) | Breast cancer, colorectal cancer, glioblastoma, HNC, lung cancer, malignant mesothelioma | I | 45/5 | ECOG: 0–2 | Safety (TEAE, MTD, DLT), PK profile | In vivo efficacy (CR, DOR, ORR, OS, PD, PR, SD, TTP), change in ECOG | AbbVie | Cleary 2020 [53] | stopped for high frequency of infusion-related reactions |
Trastuzumab deruxtecan (DS-8201A, T-Dxd) | HER2 | Camptothecin analog exatecan (DXd; DX-8951 derivative) | Cleavable tetrapeptide linker, Gly-Phe-Leu-Gly (GFLG) | Biliary tract cancer, breast cancer, colorectal cancer, endometrial cancer, lung cancer, salivary glands cancer | I | 60/8 | ECOG: 0–1 | Safety (TEAE), tolerability | In vivo efficacy (CR, DCR, ORR PD, PFS, PR, SD, TTR) | Daiichi Sankyo Inc. | Tsurutani 2020 [68] | NCT03248492—http://adc.expert/2eYaukS (accessed on May, 16th 2021) NCT03734029—https://clinicaltrials.gov/ct2/show/NCT03734029 (accessed on May 16th, 2021) NCT03523585—https://clinicaltrials.gov/ct2/show/NCT03523585 (accessed on May 16th, 2021) NCT03529110—https://clinicaltrials.gov/ct2/show/NCT03529110 (accessed onMay 16th, 2021) |
Tisotumab vedotin/TF-011-MMAE/HUMAX-TF-ADC | TF (CD142) | MMAE | Cleavable (Val-Cit) | Bladder cancer, cervix cancer, endometrial cancer, HNC, lung cancer, oesophagus cancer, ovaric cancer | I-II | 27/1 | ECOG: 0–1 | Safety (CTCAE) | MTD, PK profile, in vivo efficacy (CR, DCR, DOR, ORR, PFS, PR, SD) | Genmab/Seattle Genetics | de Bono 2019 [54] | |
Sacituzumab govitecan/IMMU-132/HRS7-SN38 | Trop-2 | Camptothecin analog (SN38) Irinotecan metabolite 7-ethyl-10 hydroxycamptothecin | Cleavable carbonate | Bladder cancer, colorectal cancer, gastrointestinal cancer, HNC, kidney cancer, lung cancer, ovaric cancer, pancreas cancer, prostate cancer | I-II | 178/2 | ECOG: 0–1 | Safety (CTCAE), PK profile | In vivo efficacy | Immunomedics | Ocean 2017 [59] | NCT01631552—https://clinicaltrials.gov/ct2/show/NCT01631552 (accessed on May 16th, 2021) NCT02161679—https://clinicaltrials.gov/ct2/show/NCT02161679 (accessed on May 16th, 2021) |
Bivatuzumab mertansine/BIWI-1 | CD44v6 | DM1 | Cleavable disulfide | HNC | I | 31/31 | ECOG: 0–2 | Safety (CTC, DLT, MTD,) PK profile | In vivo efficacy (PR, TTP) | Boehringer lngelheim Pharma GmbH | Riechelmann 2008 [62] | |
Bivatuzumab mertansine/BIWI-1 | CD44v6 | DM1 | Cleavable disulfide | HNC | I | 31/31 | NS | Safety (CTC, DLT, MTD), PK profile, immunogenicity | Boehringer Ingelheim/ImmunoGen | Sauter 2007 [63] |
ADC | Target | Payload | Linker | Weblink | Trial Identifier/Study Phase | Sponsor | Status |
---|---|---|---|---|---|---|---|
ABBV-085 | LRRC15 | MMAE | Non-cleavable | https://clinicaltrials.gov/ct2/show/study/NCT02565758 (accessed on May 16th, 2021) | NCT02565758/I | AbbVie | Completed |
A166 | HER2 | MMAF derivative | NS | https://clinicaltrials.gov/ct2/show/NCT03602079 (accessed on May 16th, 2021) | NCT03602079/I-II | Klus Pharma Inc. | Recruiting |
CX-2029 | CD71 | MMAE | Valine-citrulline (VC) peptide | https://clinicaltrials.gov/ct2/show/NCT03543813 (accessed on May 16th, 2021) | NCT03543813/I-II | CytomX Therapeutics | Recruiting |
CX-2009 | CD71 | MMAE | Valine-citrulline (VC) peptide | https://clinicaltrials.gov/ct2/show/NCT03149549 (accessed on May 16th, 2021) | NCT03149549/I-II | CytomX Therapeutics | Completed |
SBT6050 | HER2/TLR8 | TLR8 agonist | NS | https://clinicaltrials.gov/ct2/show/NCT04460456 (accessed on May 16th, 2021) | NCT04460456/I | Silverback Therapeutics | Recruiting |
ABBV-321 | EGFR | PBD | Cathepsin-cleavable maleimidocaproyl-valine-alanine | https://clinicaltrials.gov/ct2/show/study/NCT03234712 (accessed on May 16th, 2021) | NCT03234712/I | AbbVie | Ongoing |
MGC018 | B7-H3 (CD276) | Synthetic duocarmycin analogs | Cleavable valine-citrulline-seco duocarmycin hydroxy-benzamide azaindole (vc-seco-DUBA) | https://clinicaltrials.gov/ct2/show/NCT03729596 (accessed on May 16th, 2021) | NCT03729596 | MacroGenics | Recruiting |
MRG003 | EGFR | MMAE | NS | https://clinicaltrials.gov/ct2/show/NCT03729596 (accessed on May 16th, 2021) | NCT04868162 | Shanghai Miracogen Inc. | Recruiting |
ADC | Target | Payload | Linker | Government Approval | Disease | Developer |
---|---|---|---|---|---|---|
Gemtuzumab ozogamicin | CD33 | N-acetyl-γ calicheamicin 1,2-dimethyl hydrazine dichloride | 4-(4-acetylphenoxy)butanoic acid (AcBut linker) | FDA | Relapsed acute myelogenous leukemia | Pfizer/Wyeth |
Brentuximab vedotin | CD30 | Monomethyl Auristatin E | Thiolreactive maleimidocaproyl spacer, the dipeptide valine–citrulline linker, and a self-immolative, p-amino-benzyloxycarbony (PABC) spacer | FDA | Hodgkin lymphoma and systemic anaplastic large-cell lymphoma | Seattle Genetics, Millennium/Takeda |
Trastuzumab emtansine | HER2 | Maytansinoid DM1 | Non-reducible tioether linker: N-succinimidyl-4-(N-maleimidomethyl) cyclohexane-1-carboxylate linker (SMCC) | FDA | HER2-positive metastatic breast cancer following treatment with trastuzumab and a maytansinoid | Genentech, Roche |
Inotuzumab ozogamicin | CD22 | N-acetyl- γ Calicheamicin | Acid-labile(4-(4’-acetylphenoxy) butanoic acid) linker | FDA | Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia | Pfizer/Wyeth |
Polatuzumab vedotin | CD79b | Monomethyl Auristatin E | Protease-cleavable peptide linker : maleimidocaproylvaline-citrulline-p-aminobenzoyloxycarbonyl linker (MC-VC-PABC) | FDA | Relapsed or refractory diffuse large B-cell lymphoma | Genentech, Roche |
Enfortumab vedotin | Cell Surface Protein Nectin 4 | Monomethyl Auristatin E | Protease-cleavable peptide linker : maleimidocaproylvaline-citrulline-p-aminobenzoyloxycarbonyl linker (MC-VC-PABC) | FDA | Adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a Pt-containing therapy | Astellas/Seattle Genetics |
Trastuzumab deruxtecan | HER2 | A topoisomerase I inhibitor payload, a derivative of the camptothecin analog exatecan (DXd) | A tetrapeptide linker, Gly-Phe-Leu-Gly (GFLG) | FDA | Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens | AstraZeneca/Daiichi Sankyo |
Sacituzumab govitecan | TROP-2 | SN-38 (active metabolite of irinotecan) | Hydrolyzable CL2A linker | FDA | Adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for patients with relapsed or refractory metastatic disease | Immunomedics |
Belantamab mafodotin | TNFRSF17 | Monomethyl Auristatin F | A non-cleavable maleimidocaproyl (MC) linker | FDA | Multiple myeloma patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody | GlaxoSmithKline |
Loncastuximab tesirine | CD19 | SG3199/ Pyrrolobenzodiazepine (PBD) dimer SCX | A cleavable (valine-alanine dipeptide as cathepsin B cleavage site) maleimide type linker containing a PEG spacer | Japan | Relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma not otherwise specified, arising from low-grade lymphoma, and high-grade B-cell lymphoma) after two or more lines of systemic therapy | ADC Therapeutics |
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Perrotti, V.; Caponio, V.C.A.; Mascitti, M.; Lo Muzio, L.; Piattelli, A.; Rubini, C.; Capone, E.; Sala, G. Therapeutic Potential of Antibody-Drug Conjugate-Based Therapy in Head and Neck Cancer: A Systematic Review. Cancers 2021, 13, 3126. https://doi.org/10.3390/cancers13133126
Perrotti V, Caponio VCA, Mascitti M, Lo Muzio L, Piattelli A, Rubini C, Capone E, Sala G. Therapeutic Potential of Antibody-Drug Conjugate-Based Therapy in Head and Neck Cancer: A Systematic Review. Cancers. 2021; 13(13):3126. https://doi.org/10.3390/cancers13133126
Chicago/Turabian StylePerrotti, Vittoria, Vito Carlo Alberto Caponio, Marco Mascitti, Lorenzo Lo Muzio, Adriano Piattelli, Corrado Rubini, Emily Capone, and Gianluca Sala. 2021. "Therapeutic Potential of Antibody-Drug Conjugate-Based Therapy in Head and Neck Cancer: A Systematic Review" Cancers 13, no. 13: 3126. https://doi.org/10.3390/cancers13133126