PDF(Pubmed)
Abstract：
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.
METHODS: Systematic descriptive analysis.
METHODS: PubMed was searched for publications from 1 January 2000 to 18 October 2023.
METHODS: We included the phase III randomised controlled trials or phase II pivotal trials leading to approval of ADCs in solid tumours.
METHODS: 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.
METHODS: Systematic descriptive analysis.
METHODS: PubMed was searched for publications from 1 January 2000 to 18 October 2023.
METHODS: We included the phase III randomised controlled trials or phase II pivotal trials leading to approval of ADCs in solid tumours.
METHODS: 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.
摘要：
目的：本研究的目的是使用欧洲医学肿瘤学会临床获益量表（ESMO-MCBS）V.1评估已批准的抗体药物偶联物（ADC）对实体瘤的临床获益价值。
方法：系统描述性分析。
方法：PubMed搜索了2000年1月1日至2023年10月18日的出版物。
方法：我们纳入了III期随机对照试验或II期关键试验，以批准实体瘤中的ADC。
方法：两名独立评审员提取数据，差异在第三位研究者在场的情况下通过共识解决。
结果：ESMO-MCBS评分是针对8项ADC的16项阳性临床试验进行计算的，首先由美国食品和药物管理局（FDA）批准，欧洲药品管理局（EMA）中国国家医药产品管理局和日本药品和医疗器械机构的实体癌。在16项试验中，4（25%）达到ESMO-MCBS福利阈值等级，而12项(75%)方案未达到ESMO-MCBS获益阈值等级.由于其他司法管辖区的批准，16项试验中有5项（31％）没有在ESMO网站上发布记分卡，但未获得FDA或EMA的批准。在11项试验中的4项(36%)中，我们的结果与ESMO计分卡之间存在差异。主要是由于最新数据的整合。
结论：ESMO-MCBS是评估癌症药物临床获益的重要工具，但并非所有药物都符合有意义的获益阈值。
方法：系统描述性分析。
方法：PubMed搜索了2000年1月1日至2023年10月18日的出版物。
方法：我们纳入了III期随机对照试验或II期关键试验，以批准实体瘤中的ADC。
方法：两名独立评审员提取数据，差异在第三位研究者在场的情况下通过共识解决。
结果：ESMO-MCBS评分是针对8项ADC的16项阳性临床试验进行计算的，首先由美国食品和药物管理局（FDA）批准，欧洲药品管理局（EMA）中国国家医药产品管理局和日本药品和医疗器械机构的实体癌。在16项试验中，4（25%）达到ESMO-MCBS福利阈值等级，而12项(75%)方案未达到ESMO-MCBS获益阈值等级.由于其他司法管辖区的批准，16项试验中有5项（31％）没有在ESMO网站上发布记分卡，但未获得FDA或EMA的批准。在11项试验中的4项(36%)中，我们的结果与ESMO计分卡之间存在差异。主要是由于最新数据的整合。
结论：ESMO-MCBS是评估癌症药物临床获益的重要工具，但并非所有药物都符合有意义的获益阈值。
