• Michiel Zietse, van LeeuwenRoelof W FRWFDepartment of Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Medical Oncology, Erasmus University Medical Centre, Rotterdam, Netherlands., Barjesteh van Waalwijk van Doorn-KhosrovaniSaharSMedical Department, CZ Health Insurance, Tilburg, Netherlands; Department of Medical Oncology, Leiden University Medical Centre, Leiden, Netherlands., Jolanda E de Boer, Rudy Dupree, MathijssenRon H JRHJDepartment of Medical Oncology, Erasmus University Medical Centre, Rotterdam, Netherlands., and Lonneke Timmers.
• Department of Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, Netherlands.
• Lancet Oncol. 2024 Oct 14.

AbstractPrevailing 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.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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