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. 2025 Apr;45(4):471-475.
doi: 10.1002/cac2.12661. Epub 2025 Jan 16.

Bioequivalence of alternative pembrolizumab dosing regimens: current practice and future perspectives

Ruben Malmberg  1   2 , Bram C Agema  1 , Maaike M Hofman  1   3 , Stefani Oosterveld  2 , Sander Bins  1 , Daphne W Dumoulin  3 , Arjen Joosse  1 , Joachim G J V Aerts  3 , Reno Debets  1 , Birgit C P Koch  2 , Astrid A M van der Veldt  1 , Roelof W F van Leeuwen  1   2 , Ron H J Mathijssen  1
Affiliations

Bioequivalence of alternative pembrolizumab dosing regimens: current practice and future perspectives

Ruben Malmberg et al. Cancer Commun (Lond). 2025 Apr.
No abstract available

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Conflict of interest statement

None of the co‐authors have a conflict of interest in relation to the current manuscript. Ruben Malmberg reports speaker fees from Bristol Myers Squibb. Daphne W. Dumoulin reports speaker fees and consultancy fees from Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Astra Zeneca, Pfizer, and Amgen. Joachim G.J.V. Aerts reports grants from Boehringer‐Ingelheim, Merck Sharp & Dohme, Bristol Myers Squibb, Astra‐Zeneca, Eli‐Lilly, Verastem, Nutricia, Amphera, and CureVac (payments to institution and personnel). Fees for lectures: Merck Sharp &Dohme, Astra‐Zeneca, and Eli‐Lilly. Travel fees: Merck Sharp & Dohme and Astra Zeneca. Patent issued: allogeneic tumor cell lysate, combination immunotherapy. Board of directors’ member for International Association for the Study of Lung Cancer and International Mesothelioma Interest Group. Stock: Amphera. Astrid A.M. van der Veldt reports consultancy fees from Bristol Myers Squibb, Eisai, Ipsen, Merck Sharp & Dohme, Sanofi, Pierre Fabre, Novartis, Pfizer, and Roche (payments to institution). Roelof W.F. van Leeuwen reports research grants from Bristol Myers Squibb and Pfizer. Consulting fees from Bristol Myers Squibb, Pfizer, Pierre‐Fabre and Merck Sharp & Dohme. Ron H.J. Mathijssen reports research grants (payments to institution) from Astellas, Bayer, Boehringer‐Ingelheim, Cristal Therapeutics, Deuter Oncology, Echo Pharmaceuticals, Nordic Pharma, Novartis, Pamgene, Pfizer, Roche, Sanofi and Servier.

Figures

FIGURE 1
FIGURE 1
Bioequivalence point estimates acquired using the model by Li et al. [12] of the investigated dosing regimens compared to the reference 2 mg/kg dosing regimen at steady‐state. This figure illustrates the integration of two dataset: extrapolated real‐world cohort data (depicted as circles) and simulated cohort data based on a virtual cohort (depicted as triangles) (these cohorts are described in the Supplementary Material and Methods). The solid line represents the reference 2 mg/kg regimen. The dotted line represents the 80% bioequivalence threshold. †registered dose at both EMA and FDA. Abbreviations: AUC, Area under the curve; Ctrough, steady‐state trough concentration; Q3W, every three weeks; Q4W, every four weeks; Q6W, every six weeks.
See this image and copyright information in PMC

References

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