Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials
Objective The aim of this study was to assess the clinical benefit value of approved antibody drug conjugates (ADCs) for solid tumours using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) V.1.1.Design Systematic descriptive analysis.Data sources PubMed was...
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BMJ Publishing Group
2024-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/6/e077108.full |
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| author | Yang Wang Lieming Ding Xiaobin Yuan Zhilin Shen Pengxiang Wu |
| author_facet | Yang Wang Lieming Ding Xiaobin Yuan Zhilin Shen Pengxiang Wu |
| author_sort | Yang Wang |
| collection | DOAJ |
| description | Objective The aim of this study was to assess the clinical benefit value of approved antibody drug conjugates (ADCs) for solid tumours using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) V.1.1.Design Systematic descriptive analysis.Data sources PubMed was searched for publications from 1 January 2000 to 18 October 2023.Eligibility criteria We included the phase III randomised controlled trials or phase II pivotal trials leading to approval of ADCs in solid tumours.Data extraction and synthesis Two independent reviewers extracted data and discrepancies were resolved by consensus in the presence of a third investigator.Results ESMO-MCBS Scores were calculated for 16 positive clinical trials of eight ADCs, which were first approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China National Medical Products Administration and the Japanese Pharmaceuticals and Medical Devices Agency for solid cancers. Among 16 trials, 4 (25%) met the ESMO-MCBS benefit threshold grade, while 12 (75%) of the regimens did not meet the ESMO-MCBS benefit threshold grade. 5 (31%) of the 16 trials had no published scorecard on the ESMO website due to the approval by other jurisdictions but not by the FDA or EMA. Discrepancies between our results and the ESMO scorecard were observed in 4 (36%) of 11 trials, mostly owing to integration of more recent data.Conclusions ESMO-MCBS is an important tool for assessing the clinical benefit of cancer drugs, but not all drugs met the meaningful benefit threshold. |
| format | Article |
| id | doaj-art-ed952c7eeff7416d81855baeee7e1ce0 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-ed952c7eeff7416d81855baeee7e1ce02025-08-20T02:48:39ZengBMJ Publishing GroupBMJ Open2044-60552024-06-0114610.1136/bmjopen-2023-077108Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trialsYang Wang0Lieming Ding1Xiaobin Yuan2Zhilin Shen3Pengxiang Wu4Tianjin Centers for Disease Control and Prevention, Tianjin, Hedong District, ChinaBetta Pharmaceuticals Co Ltd, Hangzhou, ChinaEisai Inc, Nutley, New Jersey, USABetta Pharmaceuticals Co Ltd, Hangzhou, ChinaBetta Pharmaceuticals Co Ltd, Hangzhou, ChinaObjective The aim of this study was to assess the clinical benefit value of approved antibody drug conjugates (ADCs) for solid tumours using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) V.1.1.Design Systematic descriptive analysis.Data sources PubMed was searched for publications from 1 January 2000 to 18 October 2023.Eligibility criteria We included the phase III randomised controlled trials or phase II pivotal trials leading to approval of ADCs in solid tumours.Data extraction and synthesis Two independent reviewers extracted data and discrepancies were resolved by consensus in the presence of a third investigator.Results ESMO-MCBS Scores were calculated for 16 positive clinical trials of eight ADCs, which were first approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China National Medical Products Administration and the Japanese Pharmaceuticals and Medical Devices Agency for solid cancers. Among 16 trials, 4 (25%) met the ESMO-MCBS benefit threshold grade, while 12 (75%) of the regimens did not meet the ESMO-MCBS benefit threshold grade. 5 (31%) of the 16 trials had no published scorecard on the ESMO website due to the approval by other jurisdictions but not by the FDA or EMA. Discrepancies between our results and the ESMO scorecard were observed in 4 (36%) of 11 trials, mostly owing to integration of more recent data.Conclusions ESMO-MCBS is an important tool for assessing the clinical benefit of cancer drugs, but not all drugs met the meaningful benefit threshold.https://bmjopen.bmj.com/content/14/6/e077108.full |
| spellingShingle | Yang Wang Lieming Ding Xiaobin Yuan Zhilin Shen Pengxiang Wu Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials BMJ Open |
| title | Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials |
| title_full | Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials |
| title_fullStr | Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials |
| title_full_unstemmed | Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials |
| title_short | Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials |
| title_sort | application of the esmo magnitude of clinical benefit scale to assess the clinical benefit of antibody drug conjugates in solid cancer a systematic descriptive analysis of phase iii and pivotal phase ii trials |
| url | https://bmjopen.bmj.com/content/14/6/e077108.full |
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