Department of Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, Netherlands.
Department of Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Medical Oncology, Erasmus University Medical Centre, Rotterdam, Netherlands.
Lancet Oncol. 2024 Nov;25(11):e611-e616. doi: 10.1016/S1470-2045(24)00212-2. Epub 2024 Oct 14.
Prevailing uncertainties regarding the therapeutic interchangeability of PD-1 and PD-L1 inhibitors affect both clinical decision making and health-care budgeting. This Personal View presents a comprehensive assessment of the fragmented regulatory landscape of PD-1 and PD-L1 inhibitors, highlighting the complex dynamics of market competition, pricing, and the effect on health-care budgets. Our paper explores the current state of clinical trials, uninformative trial designs, and the challenges they pose in evaluating the therapeutic interchangeability of these drugs. To address these challenges, research that will inform us of the extent of interchangeability of PD-1 and PD-L1 inhibitors is needed. We recommend head-to-head randomised controlled trials, standardised study designs for indirect comparisons, trials with monotherapy groups, post-approval trials funded from private or public sources, and adoption of a near-equivalence framework in both conducting and evaluating trials.
目前对于 PD-1 和 PD-L1 抑制剂治疗可互换性的不确定性，影响了临床决策和医疗保健预算。本个人观点全面评估了 PD-1 和 PD-L1 抑制剂碎片化的监管格局，强调了市场竞争、定价的复杂动态及其对医疗保健预算的影响。我们的论文探讨了临床试验的现状、无信息试验设计以及它们在评估这些药物治疗可互换性方面带来的挑战。为了应对这些挑战，需要进行能够告知我们 PD-1 和 PD-L1 抑制剂可互换程度的研究。我们建议进行头对头随机对照试验、用于间接比较的标准化研究设计、单药治疗组的试验、由私人或公共来源资助的上市后试验，以及在试验的进行和评估中采用近似等效框架。
