Real-world data on efficacy/safety and economic impact of nivolumab administered every 2 and 4weeks among Japanese patients.

Abstract

A new treatment interval for nivolumab administration at 480mg every 4weeks, in addition to 240mg every 2weeks, was approved in Japan in 2020. Using model-based evaluation, it was speculated that the effects or safety of nivolumab do not differ between the two treatment intervals; however, real-world data on nivolumab efficacy, safety, and economic impact are lacking. Accordingly, we aimed to examine the effects of nivolumab treatment intervals (2weeks vs. 4weeks) in terms of efficacy, safety, and economic impact in Japanese patients with cancer. We retrospectively analyzed 126 patients treated with nivolumab. The patients were divided into two groups depending on whether they received nivolumab at 240mg every 2weeks (2-week group) or 480mg every 4weeks (4-week group). Efficacy results found no significant difference between the 4- and 2-week groups considering median overall survival (p=0.70) and median progression-free survival (p=0.57). The incidence of any grade and≥grade 3 immune-related adverse events did not differ between the 4-week and 2-week groups (any grade, p=0.13;≥grade 3, p=0.36). Excluding drug costs, the 4-week group had significantly lower medical costs than the 2-week group (2-week vs. 4-week: mean, 94,659 JPY [679.0 USD] vs. 58,737 JPY [421.3 USD]; p<0.05). Collectively, our findings suggest that nivolumab 480mg every 4weeks may be more effective than nivolumab 240mg every 2weeks in terms of economic impact.