Real-World Outcomes In Patients Receiving Nivolumab 480 Mg Every 4 Weeks Vs Other Dosing Regimens As Treatment For Melanoma In The Adjuvant Setting

Introduction: Nivolumab is approved for the adjuvant treatment of melanoma, and a 480 mg every 4 weeks (Q4W) flat-dosing monotherapy regimen was approved in the United States (March 2018). We examined real-world outcomes with different adjuvant nivolumab dosing regimens in a US community oncology setting. Methods: We conducted a retrospective chart review of US Oncology Network iKnowMed™ electronic health records of patients with melanoma receiving nivolumab from March 1, 2018, to February 28, 2019. Patients were grouped by nivolumab regimen: cohort 1 (C1), nivolumab 480 mg Q4W de novo (no prior nivolumab treatment); cohort 2 (C2), switched to nivolumab 480 mg Q4W after receiving nivolumab 240 mg or 3 mg/kg every 2 weeks (Q2W); cohort 3 (C3), nivolumab 3 mg/kg Q2W de novo; or cohort 4 (C4), nivolumab 240 mg Q2W de novo. Patients were followed for ≥6 months after nivolumab initiation. Treatment patterns and safety outcomes were compared between cohorts. Propensity score matching was performed to minimize potential selection bias (C1:C4 and C2:C4). Results: A total of 191 patients with melanoma were identified (C1, n=40; C2, n=74; C3, n=22; C4, n=55). Baseline demographic and clinical characteristics were similar in all 4 cohorts, however, C3 patients had the lowest mean body mass index (25.8 kg/m2) and the lowest proportion of patients with Eastern Cooperative Oncology Group performance status of 0 (32%). Duration of treatment and incidence of treatment-related adverse events (TRAEs) and severe TRAEs were similar across all unadjusted cohorts (Table). These results were supported by matched cohort analyses (C1:C4 and C2:C4). Rates of treatment completion (12-month course) or ongoing treatment and reasons for discontinuation varied by cohort (Table). Conclusions: This real-world data analysis of nivolumab dosing regimens shows that duration of therapy and AEs are similar between the Q2W and Q4W regimens in patients with melanoma. Citation Format: Wolfram Samlowski, Nicholas J. Robert, Esmond D. Nwokeji, Bismark Baidoo, Brad Schenkel, Andriy Moshyk, Srividya Kotapati, Tayla Poretta, Jeffrey S. Weber. Real-world outcomes in patients receiving nivolumab 480 mg every 4 weeks vs other dosing regimens as treatment for melanoma in the adjuvant setting [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 1043.