Abstract 1043: Real-world outcomes in patients receiving nivolumab 480 mg every 4 weeks vs other dosing regimens as treatment for melanoma in the adjuvant setting
Authors: Samlowski Wolfram , Robert Nicholas J. , Nwokeji Esmond D. , Baidoo Bismark , Schenkel Brad , Moshyk Andriy , Kotapati Srividya , Poretta Tayla , Weber Jeffrey S. 
Published: September 2020

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).

TableCohort 1Cohort 2Cohort 3Cohort 4Outcomes: unadjusted study populationNIVO 480 mg Q4W (de novo) N=40NIVO 480 mg Q4W (switched) N=74NIVO 3 mg/kg Q2W (de novo) N=22NIVO 240 mg Q2W (de novo) N=55Median DoT, months (95% CI)aNR (5.3-NE)9.5 (7.5-11.1)8.3 (5.2-11.7)10.8 (10.6-NE)Completed planned 12-month treatment or treatment is ongoing, %73735971Most common reasons for treatment discontinuation, %Progression1031418Toxicityb131196Patient preference0592Physician preference0400Severe TRAE, %c,d1081811Any TRAE, %d55575556Fatigue33242331Rash15181813Diarrhea1016913Hypothyroidism155511Pruritus5854Nausea5456aDoT was defined as the interval between the date of initiation of nivolumab and the last administration date, including treatment holidays or other breaks no more than 180 consecutive days in length; P=0.5797 (calculated from a test analogous to McNemar's test for correlated binary proportions [Klein and Moeschberger,1997]).bToxicity resulting in discontinuation may or may not be an AE that was explicitly attributed to NIVO.cAEs explicitly attributed to NIVO dosing regimen that led to dose withheld, dose modification, dose permanently discontinued, hospitalization, or emergency department visit. AE severity was based in part on the CTCAE v.5.0 grading system, and dose modifications were recommended in cases of adverse reactions listed in the package insert.dOccurring within 6 months from treatment initiation.AE, adverse event; CI, confidence interval; DoT, duration of treatment; NE, not estimable; NIVO, nivolumab; NR, not reached.

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.