OBJECTIVES

: To assess the estimated costs of managing grade 3-4 TRAEs requiring treatment in CheckMate-141. Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, is approved in 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.

METHODS

: 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 mostly based on Spanish National Hospital Discharge Database (Conjunto mínimo básico de datos, CMBD) and some based on regional discharge database.

RESULTS

: 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 (11.8%) and 60 among patients receiving IC (54.0%). The mean cost of managing grade 3-4 TRAEs per treated patient was 4.15 times higher in the IC arm (1.967€) than in the nivolumab arm (473€) which corresponded to a total cost of managing grade 3-4 TRAE of 111.711,62€ receiving nivolumab and 218.284,66€ in the IC arm.

CONCLUSIONS

: Patients with platinum-refractory R/M SCCHN treated with nivolumab had fewer grade 3-4 TRAEs requiring treatment (11.8% vs 54.0%), lower estimated total costs of managing TRAEs (111.711,62€ vs 218.284,66€), and reduced TRAEs costs per treated patient compared with standard, single-agent systemic therapy (473€ vs 1.967€).