Background
Nivolumab, a human IgG4 monoclonal antibody against programmed death 1 (PD-1), is approved for metastatic melanoma. The CheckMate 238 trial demonstrated one year of adjuvant nivolumab, compared with ipilimumab in resected Stage III and IV melanoma, provided longer recurrence-free survival (RFS) and lower incidence of immune related adverse events (irAEs). Patients with resected stage III and IV melanoma received adjuvant nivolumab via a patient access program (PAP) from August 2018 at our institution. This study examined local data regarding RFS and irAEs in this cohort.
Methods
We conducted a retrospective review of patients with resected Stage III and IV melanoma receiving adjuvant nivolumab via the Canberra Hospital network. Data included time from surgical resection to commencement of nivolumab, laboratory parameters prior to treatment and six weeks after cycle one of nivolumab, RFS and patterns of recurrence, irAEs and subsequent treatment post recurrence.
Results
Thirty-one patients with resected Stage III(26 pts) and IV(5 pts) melanoma commenced adjuvant nivolumab through the PAP. BRAF mutations were present in 15 patients (48%). Average time between diagnosis and treatment was 64 days. Two patients completed 12 months, 20 have ongoing treatment. Any grade irAE occurred in 48% compared with 96.9% in CheckMate 238 and grade 3/4 irAE in 9.7% vs 14.4%. IrAEs included dermatitis (32.3%), thyroiditis (25.8%), musculoskeletal (25.8%), pneumonitis (12.9%), colitis (9.7%), hepatitis (9.7%). One case each of hypophysitis (G3) and myasthenia gravis (G4) occurred. One (2.7%) stopped treatment early due to irAE. The RFS is 74% at 12 months. Of 8(25.8%) recurrences; 2 were locoregional, 6 were distant and 2 had both. 5 received further systemic treatment, 4 with immunotherapy and 1 with targeted therapy.
Conclusions
This real-word experience of adjuvant nivolumab, in a small group of patients with short follow-up, found less overall irAEs and comparable RFS to published literature.