Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, is approved in the United States and the European Union for treatment of SCCHN progressing on or after platinum-based chemotherapy. In the phase 3 CheckMate 141 trial, nivolumab significantly improved overall survival vs investigator’s choice (IC) of standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab) in patients with R/M SCCHN. This study assessed the estimated costs of managing grade 3–4 TRAEs requiring treatment in CheckMate 141.
The frequency, grade, and attribution of TRAEs for which treatment was received were extracted from CheckMate 141 patient-level safety data. Grade 3–4 TRAE treatment costs were estimated based on principle diagnosis codes of the International Classification of Disease, 9th Revision in the Healthcare Cost and Utilization Project National Inpatient Sample data (2012–2014), adjusted to reﬂect 2013-equivalent US costs.
Among the 347 patients in the safety population, 236 received nivolumab and 111 received IC. A total of 88 grade 3–4 TRAEs requiring treatment were observed: 28 among patients receiving nivolumab and 60 among patients receiving IC. The cost of managing TRAEs per treated patient was 4.5 times higher in the IC arm ($4913) than in the nivolumab arm ($1072). Patients receiving docetaxel and methotrexate had the highest incidence of TRAEs and estimated TRAE management costs (Table).Table:
|Nivolumab (n = 236)||IC (combined) (n = 111)||IC|
|Cetuximab (n = 13)||Docetaxel (n = 52)||Methotrexate (n = 46)|
|Number of grade 3–4 TRAEs requiring treatment (%)||28/88 (31.8)||60/88 (68.2)||2/60 (3.3)||36/60 (60.0)||22/60 (36.7)|
|Total estimated cost of managing grade 3–4 TRAEs, $||253,067||545,374||17,855||333,307||194,211|
|Cost of managing grade 3–4 TRAEs, mean per treated patient, $||1072||4913||1373||6410||4222|
Patients with platinum-refractory R/M SCCHN treated with nivolumab had fewer grade 3–4 TRAEs, lower estimated total costs of managing TRAEs, and reduced TRAE costs per treated patient compared with standard, single-agent systemic therapy.
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S. Bobiak: Former Bristol-Myers Squibb employee (at the time the submitted work was started); Spouse is current employee of Bristol-Myers Squibb. J.W. Shaw, M. Contente, B. Korytowsky: Bristol-Myers Squibb employee and shareholder. D.D. Stenehjem: Consulting fees from Bristol-Myers Squibb; Unrestricted research grant (unrelated to work regarding the content of this abstract) from Bristol-Myers Squibb. All other authors have declared no conflicts of interest.