Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial

The Lancet Oncology - Tập 23 - Trang 540-552 - 2022
Hedy L Kindler1, Silvia Novello2, Alessandra Bearz3, Giovanni L Ceresoli4, Joachim G J V Aerts5, James Spicer6, Paul Taylor7, Kristiaan Nackaerts8, Alastair Greystoke9, Ross Jennens10, Luana Calabrò11, Jacobus A Burgers12, Armando Santoro13,14, Susana Cedrés15, Piotr Serwatowski16, Santiago Ponce16, Jan P Van Meerbeeck17, Anna K Nowak18,19, George Blumenschein20, Jonathan M Siegel21
1Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA
2Department of Oncology, University of Turin, Orbassano, Turin, Italy
3Department of Medical Oncology and Immune-Related Cancers, CRO-IRCCS Centro di Riferimento Oncologico di Aviano, Aviano, Italy
4Department of Medical Oncology, Oncology Unit, Cliniche Humanitas Gavazzeni, Bergamo, Italy
5Department of Pulmonary Medicine, Erasmus MC Cancer Centre, Rotterdam, Netherlands
6Comprehensive Cancer Centre, King’s College London, London, UK
7Department of Medical Oncology, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK
8Laboratory of Respiratory Diseases and Thoracic Surgery, Department of Chronic Diseases and Metabolism, Universitair Ziekenhuis Leuven, KU Leuven, Leuven, Belgium
9Department of Medical Oncology, Northern Centre for Cancer Care, Newcastle upon Tyne, UK
10Epworth Cancer Services Clinical Institute, Epworth Healthcare, Richmond, VIC, Australia
11Department of Oncology, Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy
12Department of Thoracic Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands
13Humanitas University, Milan, Italy
14Department of Medical Oncology and Hematology, IRCCS Humanitas Research Hospital, Humanitas Cancer Center, Milan, Italy
15Department of Medical Oncology, University Hospital Vall d'Hebron, Barcelona, Spain
16Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain
17Department of Thoracic Oncology, Antwerp University and University Hospital and European Reference Network for Rare or Low Prevalence Complex Disease (ERN-LUNG), Antwerp, Belgium
18Medical School, University of Western Australia, Perth, WA, Australia
19National Centre for Asbestos Related Diseases, Institute for Respiratory Health, Perth, WA, Australia
20Department of Thoracic, Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
21Clinical Statistics Oncology, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA

Tài liệu tham khảo

Cantini, 2020, Emerging treatments for malignant pleural mesothelioma: where are we heading?, Front Oncol, 10, 343, 10.3389/fonc.2020.00343 Jassem, 2008, Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma, J Clin Oncol, 26, 1698, 10.1200/JCO.2006.09.9887 Fennell, 2021, Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial, Lancet Oncol, 22, 1530, 10.1016/S1470-2045(21)00471-X Novello, 2019, MS13·06 role of second line chemotherapy and new target treatment in recurrent mesothelioma, J Thorac Oncol, 14, S182, 10.1016/j.jtho.2019.08.362 Kindler, 2018, Treatment of malignant pleural mesothelioma: American Society of Clinical Oncology clinical practice guideline, J Clin Oncol, 36, 1343, 10.1200/JCO.2017.76.6394 Stebbing, 2009, The efficacy and safety of weekly vinorelbine in relapsed malignant pleural mesothelioma, Lung Cancer, 63, 94, 10.1016/j.lungcan.2008.04.001 Fennell, 2021, A randomized phase II trial of oral vinorelbine as second-line therapy for patients with malignant pleural mesothelioma, J Clin Oncol, 39 Ceresoli, 2016, Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges, Expert Rev Anticancer Ther, 16, 673, 10.1080/14737140.2016.1191951 Hassan, 2008, Mesothelin targeted cancer immunotherapy, Eur J Cancer, 44, 46, 10.1016/j.ejca.2007.08.028 Golfier, 2014, Anetumab ravtansine: a novel mesothelin-targeting antibody-drug conjugate cures tumors with heterogeneous target expression favored by bystander effect, Mol Cancer Ther, 13, 1537, 10.1158/1535-7163.MCT-13-0926 Chalouni, 2018, Fate of antibody-drug conjugates in cancer cells, J Exp Clin Cancer Res, 37, 20, 10.1186/s13046-017-0667-1 Hassan, 2020, First-in-human, multicenter, phase I dose escalation and expansion study of anti-mesothelin antibody-drug conjugate anetumab ravtansine in advanced or metastatic solid tumors, J Clin Oncol, 38, 1824, 10.1200/JCO.19.02085 Singh, 2020, Abstract 1808: loss of BAP1/BRCA1 counteracts spindle assembly checkpoint activation by the anti-mesothelin antibody drug-conjugate anetumab ravtansine, Cancer Res, 80, 10.1158/1538-7445.AM2020-1808 Hmeljak, 2018, Integrative molecular characterization of malignant pleural mesothelioma, Cancer Discov, 8, 1548, 10.1158/2159-8290.CD-18-0804 Kumar, 2019, Retrospective response analysis of BAP1 expression to predict the clinical activity of systemic cytotoxic chemotherapy in mesothelioma, Lung Cancer, 127, 164, 10.1016/j.lungcan.2018.12.004 Zalcman, 2016, Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial, Lancet, 387, 1405, 10.1016/S0140-6736(15)01238-6 Byrne, 2004, Modified RECIST criteria for assessment of response in malignant pleural mesothelioma, Ann Oncol, 15, 257, 10.1093/annonc/mdh059 Zucali, 2008, Gemcitabine and vinorelbine in pemetrexed-pretreated patients with malignant pleural mesothelioma, Cancer, 112, 1555, 10.1002/cncr.23337 Mendoza, 2019, Evaluation of the psychometric properties and minimally important difference of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM), J Patient Rep Outcomes, 3, 34, 10.1186/s41687-019-0122-5 Cristaudo, 2007, Clinical significance of serum mesothelin in patients with mesothelioma and lung cancer, Clin Cancer Res, 13, 5076, 10.1158/1078-0432.CCR-07-0629 Bueno, 2016, Comprehensive genomic analysis of malignant pleural mesothelioma identifies recurrent mutations, gene fusions and splicing alterations, Nat Genet, 48, 407, 10.1038/ng.3520 Phallen, 2017, Direct detection of early-stage cancers using circulating tumor DNA, Sci Transl Med, 9, 10.1126/scitranslmed.aan2415 Hylebos, 2018, Tumor-specific genetic variants can be detected in circulating cell-free DNA of malignant pleural mesothelioma patients, Lung Cancer, 124, 19, 10.1016/j.lungcan.2018.07.028 Wang, 2004, A requirement for breast-cancer-associated gene 1 (BRCA1) in the spindle checkpoint, Proc Natl Acad Sci USA, 101, 17108, 10.1073/pnas.0407585101 Busacca, 2021, BRCA1/MAD2L1 deficiency disrupts the spindle assembly checkpoint to confer vinorelbine resistance in mesothelioma, Mol Cancer Ther, 20, 379, 10.1158/1535-7163.MCT-20-0363 Zhang, 2021, Clonal architecture in mesothelioma is prognostic and shapes the tumour microenvironment, Nat Commun, 12