3PC-020 Nivolumab weight-based dosing vs flat dose economic analysis

Bianconi, C.; Gandini, Giorgio; Zanotti, Giovanni; Dall’Ara, Maria C.; Sterzi, Enrico; Barbazza, Roberto; Marini, Paola

doi:10.1136/ejhpharm-2019-eahpconf.101

Cited by 2 publications

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“…36 While fixed-dose nivolumab and pembrolizumab simplifies prescribing, preparation, and inventory, potentially improving safety by reducing dosing errors, a number of studies have projected that fixed-dose results in increased drug costs, translating to a difference of hundreds of thousands of dollars annually across the growing population of patients eligible for ICI. [37][38][39] Other concerns include inadequate accounting for the complexity of dose modeling for checkpoint inhibitors (which often include an immune-related biomarker such as IL-2 release as well as translational PK/PD response models from preclinical studies) and insufficient power to compare directly outcomes from 2 and 10 mg/kg pembrolizumab dose cohorts in clinical trials. 40 It is also possible that 10 mg/kg may not be an ideal comparator, as it has been suggested that high-dose antibody administration paradoxically results in reduced exposure.…”

Section: Discussionmentioning

confidence: 99%

Association between body mass index, dosing strategy, and efficacy of immune checkpoint inhibitors

Ahmed

Itzstein

Sheffield

et al. 2021

J Immunother Cancer

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BackgroundIncreased body mass index (BMI) has been associated with improved response to immune checkpoint inhibitors (ICIs) in multiple cancer types. We evaluated associations between BMI, ICI dosing strategy, and clinical outcomes.MethodsWe abstracted clinical data on patients with cancer treated with ICI, including age, sex, cancer type, BMI, ICI type, dosing strategy (weight-based or fixed), radiographic response, overall survival (OS), and progression-free survival (PFS). We compared clinical outcomes between low-BMI and high-BMI populations using Kaplan-Meier curves, Cox regressions, and Pearson product-moment correlation coefficients.ResultsA total of 297 patients were enrolled, of whom 40% were women and 59% were overweight (BMI≥25). Of these, 204 (69%) received fixed and 93 (31%) received weight-based ICI dosing. In the overall cohort, overweight BMI was associated with improved PFS (HR 0.69; 95% CI 0.51 to 0.94; p=0.02) and had a trend toward improved OS (HR 0.77; 95% CI 0.57 to 1.04; p=0.08). For both endpoints, improved outcomes in the overweight population were limited to patients who received weight-based ICI dosing (PFS HR 0.53; p=0.04 for weight-based; vs HR 0.79; p=0.2 for fixed dosing) (OS HR 0.56; p=0.03 for weight-based; vs HR 0.89; p=0.54 for fixed dosing). In multivariable analysis, BMI was not associated with PFS or OS. However, the interaction of BMI≥25 and weight-based dosing had a trend toward association with PFS (HR 0.53; 95% CI 0.26 to 1.10; p=0.09) and was associated with OS (HR 0.50; 95% CI 0.25 to 0.99; p=0.05). Patients with BMI<25 tended to have better outcomes with fixed-dose compared with weight-based ICI, while patients with BMI≥25 tended to have better outcomes with weight-based ICI, although these differences did not achieve statistical significance. There was no association between radiographic response and BMI with fixed-dose ICI (p=0.97), but a near-significant trend with weight-based ICI (p=0.1). In subset analyses, the association between BMI, ICI dosing strategy, and clinical outcomes appeared limited to men.ConclusionsThe clinical benefit of ICI in high-BMI populations appears limited to individuals receiving weight-based ICI dosing. Further research into optimal ICI dosing strategies may be warranted.

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Section: Discussionmentioning

confidence: 99%

Association between body mass index, dosing strategy, and efficacy of immune checkpoint inhibitors

Ahmed

Itzstein

Sheffield

et al. 2021

J Immunother Cancer

View full text Add to dashboard Cite

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“… 1 Multiple analyses have demonstrated the use of a flat dose rather than a weight-based dose for these agents leads to higher doses administered to patients, which in turn leads to higher costs. 2 – 5 It is with this background that we present the results of an investigation of the cost effectiveness of flat-dosing in nivolumab and pembrolizumab at a large Irish oncology centre: Cork University Hospital.…”

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confidence: 99%