Background and importance Nivolumab and pembrolizumab are monoclonal antibodies that avoid programmed death-1 (PD-1) mediated downregulation of T-cells by binding to the receptor and blocking its interaction with ligands PD-L1 and PD-L2.
Inmunotherapy fixed-dose (FD) inclusion in daily clinical practice has led to a significant economic impact. Nevertheless, some studies grant the equivalence of nivolumab1 and pembrolizumab2 at individualised-dose (ID) (nivolumab 3 mg/kg/2w, pembrolizumab 2 mg/kg/3w) and FD (nivolumab 240 mg/2w, 480 mg/4w; pembrolizumab 200 mg/3w).
Aim and objectives Evaluating the impact of dose-binding (DB) application in immunotherapy with nivolumab and pembrolizumab in terms of efficiency, clinical assistance and pharmacological exposure.
Material and methods An observational retrospective observational study including patients treated with nivolumab and pembrolizumab from January 2019 to September 2021 was conducted, specifying anthropometrical features and number of cycles administered.
Dosage adjustment intervals were designed for nivolumab (<60 kg: 170 mg, 60–70 kg: 200 mg, 70–80 kg: 230 mg, >80 kg: 240 mg) and pembrolizumab (<70 kg: 130 mg, 70–90 kg: 160 mg, >90 kg: 200 mg). Clinical application of DB was assessed according to annual saving of both therapies (efficiency), difference in cycles administered per year (clinical assistance) and dosage discrepancy between DB-FD (pharmacological exposure).
Results 195 patients were included: 68 (34.9%) nivolumab and 127 (65.1%) pembrolizumab. Mean body weight was 72.1 ±12.8 kg and 71.4 ±13.6 kg, respectively. 1849 immunotherapeutic cycles were administered: 705 (38.1%) nivolumab and 1144 (61.9%) pembrolizumab.
The annual economic impact of FD and DB was calculated at €573 235 and €529 556 for nivolumab and €110 3387 and €820 262 for pembrolizumab, respectively; estimating a potential annual economical saving for DB of nivolumab at €43 679 and pembrolizumab at €283 125. The application of DB in nivolumab would lead to an increase of 58 annual cycles administered, with no change in the case of pembrolizumab. In terms of drug exposure, immunotherapy with DB dosage would suppose a median dose deviation from FD of −4.17% (−16.67–0.0) for nivolumab and −20.0% (−35.0 to −20.0) for pembrolizumab.
Conclusion and relevance The implantation of a DB programme in immunotherapy with nivolumab and pembrolizumab would lead to an efficiency increase and a dosing reduction in comparison with FD regimens, especially in pembrolizumab, which would achieve higher annual savings without detriment of clinical assistance.
References and/or acknowledgements 1. DOI:10.1093/annonc/mdx235
Conflict of interest No conflict of interest