Antibody-drug conjugates, immune-checkpoint inhibitors, and their combination in advanced non-small cell lung cancer

Cancer Treatment and Research Communications - Tập 36 - Trang 100713 - 2023
Idoko Salifu1, Navneet Singh2, Maria Berraondo1, Jordi Remon3, Stephanie Salifu4, Eric Severson1, Angela Quintana5, Sandra Peiró5, Shakti Ramkissoon1,6, Laura Vidal1, Isagani Chico1, Kamal S. Saini1,7
1Labcorp Drug Development Inc., Princeton, NJ, USA
2Postgraduate Institute of Medical Education and Research, Chandigarh, India
3Paris-Saclay University, department of Cancer Medicine, Gustave Roussy, Villejuif, France
4Dix Hills, NY, USA
5Vall d'Hebron Institute of Oncology, Barcelona, Spain
6Department of Pathology, Wake Forest School of Medicine and Comprehensive Cancer Center, Winston-Salem, NC, USA
7Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

Tài liệu tham khảo

Reck, 2021, Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non–small-cell lung cancer with PD-L1 tumor proportion score ≥ 50%, J. Clin. Oncol., 39, 2339, 10.1200/JCO.21.00174 Gandhi, 2018, Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer, N. Engl. J. Med., 378, 2078, 10.1056/NEJMoa1801005 Paz-Ares, 2018, Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer, N. Engl. J. Med., 379, 2040, 10.1056/NEJMoa1810865 Lamberti, 2020, Beyond EGFR, ALK and ROS1: current evidence and future perspectives on newly targetable oncogenic drivers in lung adenocarcinoma, Crit. Rev. Oncol. Hematol., 156, 10.1016/j.critrevonc.2020.103119 Steuer, 2022, Efficacy and safety of patritumab deruxtecan (HER3-DXd) in advanced/metastatic non-small cell lung cancer (NSCLC) without EGFR -activating mutations, J. Clin. Oncol., 40, 9017, 10.1200/JCO.2022.40.16_suppl.9017 Spira A.I. IASLC | International association for the study of lung cancer. Accessed January 3, 2023. https://library.iaslc.org/search-speaker?search_speaker=87361. Rizzo, 2022, Identifying optimal first-line treatment for advanced non-small cell lung carcinoma with high PD-L1 expression: a matter of debate, Br. J. Cancer, 127, 1381, 10.1038/s41416-022-01929-w Viscardi, 2022, Comparative assessment of early mortality risk upon immune checkpoint inhibitors alone or in combination with other agents across solid malignancies: a systematic review and meta-analysis, Eur. J. Cancer Oxf. Engl. 1990, 177, 175 Saini, 2021, Antibody-drug conjugates, immune-checkpoint inhibitors, and their combination in breast cancer therapeutics, Expert Opin. Biol. Ther., 21, 945, 10.1080/14712598.2021.1936494 2023 AstraZeneca. A Phase 1b, multicenter, 2-part, open-label study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (Tropion-Lung04). clinicaltrials.gov; 2022. Accessed January 22, 2023. https://clinicaltrials.gov/ct2/show/NCT04612751. Tong, 2021, An insight into FDA approved antibody-drug conjugates for cancer therapy, Mol. Basel Switz, 26, 5847 Iwata, 2019, [Fam-] trastuzumab deruxtecan (DS-8201a)-induced antitumor immunity is facilitated by the anti–CTLA-4 antibody in a mouse model. Najbauer J, ed, PLoS ONE, 14, 10.1371/journal.pone.0222280 Hotta, 2018, A phase II study of trastuzumab emtansine in HER2-positive non-small cell lung cancer, J. Thorac. Oncol. Off. Publ. Int. Assoc. Study Lung Cancer, 13, 273 Stinchcombe, 2017, Efficacy, safety, and biomarker results of trastuzumab emtansine (T-DM1) in patients (pts) with previously treated HER2-overexpressing locally advanced or metastatic non-small cell lung cancer (mNSCLC), J. Clin. Oncol., 35, 8509, 10.1200/JCO.2017.35.15_suppl.8509 Li, 2018, Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 36, 2532, 10.1200/JCO.2018.77.9777 NCCN Clinical Practice Guidelines in Oncology, Non-small cell lung cancer NCCN Evidence block. Published online March 16, 2022. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. Li, 2022, Trastuzumab deruxtecan in HER2 -mutant non–small-cell lung cancer, N. Engl. J. Med., 386, 241, 10.1056/NEJMoa2112431 Li Bob T, Smit Egbert F, Goto Yasushi, et al. ESMO 2022- Phase 2 trial of trastuzumab deruxtecan in patients with HER2-mutant metastatic non–small cell lung cancer: updated analyses from DESTINY-lung01. Accessed January 3, 2023. https://oncologypro.esmo.org/meeting-resources/esmo-congress?event_resources_filter_form%5Bsearch%5D=Bob%20T.%20Li. Smit, 2022, 975P Trastuzumab deruxtecan in patients (pts) with HER2-overexpressing (HER2-OE) metastatic non-small cell lung cancer (NSCLC): results from the DESTINY-Lung01 trial, Ann. Oncol., 33, S994, 10.1016/j.annonc.2022.07.1103 Goto, 2022, LBA55 Trastuzumab deruxtecan (T-DXd) in patients (Pts) with HER2-mutant metastatic non-small cell lung cancer (NSCLC): interim results from the phase 2 DESTINY-Lung02 trial, Ann. Oncol., 33, S1422, 10.1016/j.annonc.2022.08.057 Pacheco, 2018, Antibody drug conjugates in thoracic malignancies, Lung Cancer Amst. Neth., 124, 260, 10.1016/j.lungcan.2018.07.001 Heist, 2017, Therapy of advanced non-small-cell lung cancer with an SN-38-anti-trop-2 drug conjugate, sacituzumab govitecan, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 35, 2790, 10.1200/JCO.2016.72.1894 Garon E.B. IASLC | International association for the study of lung cancer. Accessed January 6, 2023. https://library.iaslc.org/virtual-library-search?product_id=24&author=&category=&date=&session_type=&session=&presentation=MA03.02&keyword=. Garon, 2021, MA03.02 TROPION-pantumor01: updated results from the NSCLC cohort of the phase 1 study of datopotamab deruxtecan in solid tumors, J. Thorac. Oncol., 16, S892, 10.1016/j.jtho.2021.08.118 Efficacy of datopotamab deruxtecan (Dato-DXd) in patients (pts) with advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC) and actionabl... | OncologyPRO. Accessed January 13, 2023. https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/efficacy-of-datopotamab-deruxtecan-dato-dxd-in-patients-pts-with-advanced-metastatic-adv-met-non-small-cell-lung-cancer-nsclc-and-actionabl. PVI_slides_22ADC.pdf. Accessed January 13, 2023. https://c.peerview.com/live/programs/150207897-1/downloads/PVI_slides_22ADC.pdf?Promocode=&ProjectNumber=150207897_1. Camidge, 2021, Phase I study of 2- or 3-week dosing of telisotuzumab vedotin, an antibody-drug conjugate targeting c-Met, monotherapy in patients with advanced non-small cell lung carcinoma, Clin. Cancer Res. Off. J. Am. Assoc. Cancer Res., 27, 5781, 10.1158/1078-0432.CCR-21-0765 Camidge, 2022, Telisotuzumab vedotin (Teliso-V) monotherapy in patients (pts) with previously treated c-Met–overexpressing (OE) advanced non-small cell lung cancer (NSCLC), J. Clin. Oncol., 40, 9016, 10.1200/JCO.2022.40.16_suppl.9016 Home - ClinicalTrials.gov. Accessed November 5, 2022. https://www.clinicaltrials.gov/ct2/home. Pa, 2022, Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated non-small cell lung cancer, Cancer Discov., 12 Gazzah, 2020, Efficacy and safety of the antibody-drug conjugate (ADC) SAR408701 in patients (pts) with non-squamous non-small cell lung cancer (NSQ NSCLC) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), J. Clin. Oncol., 38, 9505, 10.1200/JCO.2020.38.15_suppl.9505 Ricordel, 2022, Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with nonsquamous non–small cell lung cancer (NSQ NSCLC) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), J. Clin. Oncol., 40, 9039, 10.1200/JCO.2022.40.16_suppl.9039 Garassino, 2022, 973MO KEYNOTE-189 5-year update: first-line pembrolizumab (pembro) + pemetrexed (pem) and platinum vs placebo (pbo) + pem and platinum for metastatic nonsquamous NSCLC, Ann. Oncol., 33, S992, 10.1016/j.annonc.2022.07.1101 5-year update from KEYNOTE-407: pembrolizumab plus chemotherapy in squamous non-small cell lung cancer (NSCLC) | OncologyPRO. Accessed January 5, 2023. https://oncologypro.esmo.org/meeting-resources/esmo-congress/5-year-update-from-keynote-407-pembrolizumab-plus-chemotherapy-in-squamous-non-small-cell-lung-cancer-nsclc. Mok, 2019, Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial, Lancet Lond. Engl., 393, 1819, 10.1016/S0140-6736(18)32409-7 Castro, 2021, 363 KEYNOTE-042 5-year survival update: pembrolizumab versus chemotherapy in patients with previously untreated, PD-L1–positive, locally advanced or metastatic non–small-cell lung cancer, J. Immunother. Cancer, 9, A390, 10.1136/jitc-2021-SITC2021.363 Herbst, 2016, Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial, Lancet Lond. Engl., 387, 1540, 10.1016/S0140-6736(15)01281-7 Brahmer, 2015, Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer, N. Engl. J. Med., 373, 123, 10.1056/NEJMoa1504627 Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N. Engl. J. Med., 373, 1627, 10.1056/NEJMoa1507643 Barlesi, 2016, Long-term outcomes with nivolumab (Nivo) vs docetaxel (Doc) in patients (Pts) with advanced (Adv) NSCLC: checkMate 017 and CheckMate 057 2-y update, Ann. Oncol., 27, vi420, 10.1093/annonc/mdw383.15 Hellmann, 2019, Nivolumab plus ipilimumab in advanced non-small-cell lung cancer, N. Engl. J. Med., 381, 2020, 10.1056/NEJMoa1910231 Brahmer, 2022, Five-year survival outcomes with nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for metastatic non–small cell lung cancer (NSCLC): results from CheckMate 227, J. Clin. Oncol., 40, 10.1200/JCO.2022.40.17_suppl.LBA9025 Paz-Ares, 2021, First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial, Lancet Oncol., 22, 198, 10.1016/S1470-2045(20)30641-0 Paz-Ares, 2022, First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients (pts) with metastatic non–small cell lung cancer (NSCLC): 3-year update from CheckMate 9LA, J. Clin. Oncol., 40, 10.1200/JCO.2022.40.17_suppl.LBA9026 JNCCN 360 - NSCLC - ASCO 2022: 3-year trial update on nivolumab plus ipilimumab and chemotherapy for metastatic NSCLC. Accessed November 3, 2022. https://jnccn360.org/nsclc/news/asco-2022-3-year-trial-update-on-nivolumab-plus-ipilimumab-and-chemotherapy-for-metastatic-nsclc/. Sezer, 2021, Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial, Lancet Lond. Engl., 397, 592, 10.1016/S0140-6736(21)00228-2 Ozguroglu M., Kilickap S., Sezer A., Gumus M., Bondarenko I., Gogishvili M., Nechaeva M., Schenker M., Cicin I., Ho G.F., Kulyab Y., Dvorkin M., Zyuhal K. , Scheusan R.I., Li S., Pouliot J., Seebach F., Lowy I., Gullo G., Rietschel P. ESMO 2022: three years survival outcome and continued cemiplimab (CEMI) beyond progression with the addition of chemotherapy (chemo) for patients (pts) with advanced non-small cell lung cancer (NSCLC): the EMPOWER-Lung 1 trial. Accessed November 3, 2022. https://clin.larvol.com/abstract-detail/ESMO%202022/58748759/254711. Gogishvili, 2022, Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial, Nat. Med., 28, 2374, 10.1038/s41591-022-01977-y Herbst, 2020, Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC, N. Engl. J. Med., 383, 1328, 10.1056/NEJMoa1917346 Jassem, 2021, Updated overall survival analysis from IMpower110: atezolizumab versus platinum-based chemotherapy in treatment-naive programmed death-ligand 1–selected NSCLC, J. Thorac. Oncol., 16, 1872, 10.1016/j.jtho.2021.06.019 Socinski, 2018, Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC, N. Engl. J. Med., 378, 2288, 10.1056/NEJMoa1716948 West, 2019, Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial, Lancet Oncol., 20, 924, 10.1016/S1470-2045(19)30167-6 Antonia, 2017, Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer, N. Engl. J. Med., 377, 1919, 10.1056/NEJMoa1709937 Antonia, 2018, Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC, N. Engl. J. Med., 379, 2342, 10.1056/NEJMoa1809697 Spigel, 2022, Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer, J. Clin. Oncol., 10.1200/JCO.21.01308 Johnson, 2022, Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non–small-cell lung cancer: the phase III POSEIDON study, J. Clin. Oncol. Vanmeerbeek, 2020, Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology, Oncoimmunology, 9, 10.1080/2162402X.2019.1703449 Zhou, 2016, The oncolytic peptide LTX-315 triggers immunogenic cell death, Cell Death. Dis., 7, e2134, 10.1038/cddis.2016.47 Fucikova, 2020, Detection of immunogenic cell death and its relevance for cancer therapy, Cell Death. Dis., 11, 1013, 10.1038/s41419-020-03221-2 Hayashi, 2020, Tipping the immunostimulatory and inhibitory DAMP balance to harness immunogenic cell death, Nat. Commun., 11, 6299, 10.1038/s41467-020-19970-9 Iwata, 2019, [Fam-] trastuzumab deruxtecan (DS-8201a)-induced antitumor immunity is facilitated by the anti-CTLA-4 antibody in a mouse model, PLoS ONE, 14, 10.1371/journal.pone.0222280 Šmahel, 2017, PD-1/PD-L1 blockade therapy for tumors with downregulated MHC class I expression, Int. J. Mol. Sci., 18, E1331, 10.3390/ijms18061331 Page, 2019, Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer, Npj Breast Cancer, 5, 34, 10.1038/s41523-019-0130-x McKenzie, 2017, The effect of topoisomerase I inhibitors on the efficacy of T-cell-based cancer immunotherapy, JNCI J. Natl. Cancer Inst, 110, 777, 10.1093/jnci/djx257 Stagg, 2011, Anti-ErbB-2 mAb therapy requires type I and II interferons and synergizes with anti-PD-1 or anti-CD137 mAb therapy, Proc. Natl. Acad. Sci. U. S. A., 108, 7142, 10.1073/pnas.1016569108 Yamazaki, 2020, PT-112 induces immunogenic cell death and synergizes with immune checkpoint blockers in mouse tumor models, Oncoimmunology, 9, 10.1080/2162402X.2020.1721810 Bauzon, 2019, Maytansine-bearing antibody-drug conjugates induce in vitro hallmarks of immunogenic cell death selectively in antigen-positive target cells, Oncoimmunology, 8, 10.1080/2162402X.2019.1565859 Han H.S., Diab S., Alemany C., et al. Open label phase 1b/2 study of ladiratuzumab vedotin in combination with pembrolizumab for first-line treatment of patients with unresectable locally-advanced or metastatic triple-negative breast cancer, Cancer Res (2020) 80 (4_Supplement), doi:10.1158/1538-7445.sabcs19-pd1-06. Cao A.T., Heiser R.A., Law C., Gardai S. Abstract 4914: Auristatin-based antibody drug conjugates activate multiple ER stress response pathways resulting in immunogenic cell death and amplified T-cell responses. Published online 2016. doi:10.1158/1538-7445.AM2016-4914. Kepp, 2019, Clinical evidence that immunogenic cell death sensitizes to PD-1/PD-L1 blockade, Oncoimmunology, 8, 10.1080/2162402X.2019.1637188 Gerber, 2016, Combining antibody-drug conjugates and immune-mediated cancer therapy: what to expect?, Biochem. Pharmacol., 102, 1, 10.1016/j.bcp.2015.12.008 Müller, 2015, Trastuzumab emtansine (T-DM1) renders HER2+ breast cancer highly susceptible to CTLA-4/PD-1 blockade, Sci. Transl. Med., 7, 10.1126/scitranslmed.aac4925 Datopotamab Deruxtecan (Dato-DXd) and pembrolizumab with or without platinum chemotherapy in 1L non-small cell lung cancer (TROPION-Lung07) - full text view - ClinicalTrials.gov. Accessed January 6, 2023. https://clinicaltrials.gov/ct2/show/NCT05555732. Puzanov, 2017, Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group, J. Immunother. Cancer, 5, 95, 10.1186/s40425-017-0300-z Man, 2018, Treatment-related toxicities of immune checkpoint inhibitors in advanced cancers: a meta-analysis, Asia Pac. J. Clin. Oncol., 14, 141, 10.1111/ajco.12838 Masters, 2018, Clinical toxicity of antibody drug conjugates: a meta-analysis of payloads, Invest. New Drugs, 36, 121, 10.1007/s10637-017-0520-6 Hamilton E., Shapiro C., Petrylak D. 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. Accessed October 8, 2022. https://www.abstractsonline.com/pp8/#!/9223/presentation/798. Drugs@FDA: fDA-Approved Drugs. Accessed November 5, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Emens, 2020, Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial, Lancet Oncol., 21, 1283, 10.1016/S1470-2045(20)30465-4 Waks, 2020, A phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC), J. Clin. Oncol., 38, 1046, 10.1200/JCO.2020.38.15_suppl.1046 Drugs@FDA: fDA-approved drugs. Accessed October 11, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. 2019, Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry, Ann. Oncol., 30, 1321, 10.1093/annonc/mdz167 Calles, 2020, Checkpoint blockade in lung cancer with driver mutation: choose the road wisely, Am. Soc. Clin. Oncol. Educ. Book, 372, 10.1200/EDBK_280795