# The Real-World Efficacy and Side Effects of Different Nivolumab Regimens in Japanese Patients with Advanced Melanoma: A Single-Center Retrospective Study

## TL;DR

This study compares different dosing regimens of nivolumab in Japanese patients with advanced melanoma, finding no major differences in long-term outcomes or side effects.

## Contribution

The study provides real-world evidence on nivolumab regimens in Japanese patients, highlighting the impact of dosing intervals on short-term response rates.

## Key findings

- Shorter administration intervals may improve objective response rates in Japanese patients with advanced melanoma.
- Long-term efficacy and side effects did not differ significantly between the 240 mg and 480 mg regimens.
- No significant differences in progression-free survival or overall survival were observed across regimens.

## Abstract

Nivolumab is currently administered for advanced melanoma at either 240 mg every 2 weeks or 480 mg every 4 weeks. However, limited data are available comparing the effectiveness of these regimens. In this retrospective study, we analyzed 153 Japanese patients with melanoma, including those who previously received 3 mg/kg every 2 weeks or 2 mg/kg every 3 weeks. The analysis indicated that shorter administration intervals may improve the objective response rate, although long-term efficacy and side effects did not differ significantly by regimen or dosage. Given the comparable efficacy and toxicity between the 240 mg and 480 mg regimens, we recommend that clinicians discuss options with patients and select the most suitable regimen collaboratively.

Background/Objectives: Nivolumab is a key therapy for advanced-stage melanoma; however, limited data are available from Asian populations comparing the efficacy and side effects of four dosing regimens: 3 mg/kg every 2 weeks (3mg/kgQ2W), 2 mg/kg every 3 weeks (2mg/kgQ3W), 240 mg every 2 weeks (240mgQ2W), and 480 mg every 4 weeks (480mgQ4W). This retrospective study evaluated Japanese patients with advanced melanoma treated with various nivolumab regimens to assess the impact of dosing interval and dosage on treatment efficacy and immune-related adverse events (irAEs). Methods: We reviewed the records of 153 participants with stage IV melanoma who received nivolumab monotherapy between February 2012 and December 2024 at Shizuoka Cancer Center. Patients were categorized by nivolumab regimen, dosing interval, and dose per body weight. We then compared treatment efficacy and incidence of irAEs across groups. Results: No significant differences were observed in objective response rate (ORR), progression-free survival (PFS), overall survival (OS), or irAE incidence between the 240mgQ2W and 480mgQ4W groups. Similar results were observed in the 3mg/kgQ2W and 2mg/kgQ3W groups. However, participants who received nivolumab within 3 weeks exhibited a significantly higher ORR than those who received nivolumab more than 3 weeks. No significant differences were found in PFS or OS. Conclusions: The administration of nivolumab at shorter intervals may provide short-term benefits in Japanese patients with advanced melanoma. However, long-term efficacy and side effects did not differ significantly across the studied nivolumab regimens.