Evaluation of safety outcomes between nivolumab regimens with differing dosing patterns

Area of Science:

• Oncology
• Immunotherapy
• Pharmacovigilance

Background:

• Previous studies suggested similar safety profiles for different nivolumab dosing regimens.
• Limitations in prior research included a narrow patient population, small sample size, and insufficient statistical power.
• This study aimed to compare real-world safety outcomes of distinct nivolumab dosing schedules across diverse solid tumor types.

Purpose of the Study:

• To evaluate and compare the incidence of immunotherapy-related adverse effects (irAEs) between nivolumab administered every two weeks (Q2W) and every four weeks (Q4W).
• To assess differences in specific irAEs, significant irAEs, and treatment discontinuation rates among nivolumab dosing regimens.
• To provide real-world data on the safety profiles of different nivolumab dosing strategies in various solid tumor patients.

Main Methods:

• A single-center retrospective cohort study included adult patients with solid tumors receiving nivolumab 240mg Q2W, 480mg Q4W, or transitioned between these doses.
• Data were collected from March 2018 to March 2022 using electronic health records.
• The primary endpoint was the incidence of irAEs, with secondary endpoints including significant irAEs and reasons for discontinuation, analyzed using univariate and multivariate methods.

Main Results:

• The 240mg Q2W nivolumab regimen was linked to a significant increase in colitis incidence.
• The 480mg Q4W nivolumab regimen showed a significant increase in pruritis incidence.
• No overall difference in irAE incidence was observed between cohorts, but significant irAEs were more frequent in the 240mg Q2W and transition cohorts.

Conclusions:

• Different nivolumab dosing schedules (240mg Q2W vs. 480mg Q4W) are associated with distinct irAE profiles.
• Clinicians should be aware of these specific irAE risks when selecting nivolumab dosing regimens.
• The findings highlight the importance of individualized patient monitoring based on the prescribed nivolumab dosing schedule.