Abstract
Introduction
Nivolumab has demonstrated promising survival outcomes in melanoma. Original dosing was 3 mg/kg (maximum 240 mg) intravenously (IV) every two weeks (Q2 W). Based on pharmacokinetic and pharmacodynamic studies demonstrating similar efficacy, 6 mg/kg (maximum 480 mg) IV every four weeks (Q4 W) dosing was introduced. However, real-world effectiveness data remains limited. This study analyzed real-world effectiveness between Q2 W versus Q4 W nivolumab dosing intervals in adjuvant and metastatic melanoma patients.
Methods
A retrospective chart review was conducted to compare overall survival (OS), progression free survival (PFS), prescribing trends, and reasons for switching intervals between Q2 W versus Q4 W nivolumab dosing in advanced and adjuvant melanoma patients. Patients started nivolumab between January 1st, 2019, to December 31st, 2020, and were followed up until July 31st, 2024. Patients were stratified based on the treatment intent.
Results
Seventy patients (advanced n = 27, adjuvant n = 43) were included. Baseline characteristics were similar between the dosing groups for each treatment intent. In the advanced group, the median time of PFS was 7.8 months (95% CI 0.0 to 48.9 months) for Q2 W group versus 11.7 months (95% CI 0.0 to 33.7 months) for the Q4 W group. The median time of OS was 32.0 months (95% CI 0.0 to 107.2 months) for the Q2 W group compared to 25.2 months (95% CI 0 to 66.7 months) for the Q4 W group. Meanwhile, in the adjuvant group, OS and PFS outcomes were not reached at follow-up: 14/20 (70.0%) and 13/23 (56.5%) patients have not progressed in the Q2 W and Q4 W groups respectively. There were 16/20 (80.0%) and 17/23 (73.9%) who were still alive at the end of follow up in the Q2 W and Q4 W groups, respectively.
Conclusions
In advanced melanoma patients, Q4 W dosing showed comparable effectiveness with Q2 W dosing. Based on these results and previous real-world evidence demonstrating similar safety profiles, Q4 W dosing provides an alternative dosing interval that may lead to decreased healthcare utilization and exposure, while supporting environmental initiatives.
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