Outcome of adjuvant immunotherapy in a real-world nation-wide cohort of patients with melanoma.

Background: Clinical trials have demonstrated promising outcomes for adjuvant immunotherapy in patients with resected melanoma. Real-life data provide valuable insights to support patient guidance and treatment decisions.
Methods: Observational population-based study examining a national cohort of patients with resected stage III-IV melanoma referred for adjuvant therapy. Data were extracted from the Danish Metastatic Melanoma Database (DAMMED).
Results: Between November 2018 and January 2022, 785 patients received adjuvant anti-PD-1. The majority had stage III resected melanoma (87%), normal LDH levels (80%), and performance score 0 (87%). Patients were followed for a median of 25.6 months (95%CI 24-28). The median recurrence-free survival (RFS) and melanoma-specific survival (MSS) were not reached. The RFS was 78% (95%CI 75-81), 66% (63-70), and 59% (55-63); MSS was 97% (95-98), 93% (91-95), and 87% (84-90) at 1-, 2-, and 3-year; respectively. Less than half (42%) of the patients finalized planned therapy, 32% discontinued due to toxicity, and 19% due to melanoma recurrence. Patients discontinuing adjuvant treatment prematurely, without recurrence, had similar outcomes as patients finalizing therapy. In a multivariable analysis, ipilimumab plus nivolumab did not improve outcomes compared to ipilimumab monotherapy as a first-line metastatic treatment after adjuvant anti-PD-1.
Conclusion: Survival outcomes in real-world patients with melanoma treated with adjuvant anti-PD-1 align with results from the randomized controlled trials. Patients discontinuing therapy prematurely, for other reasons than recurrence, had similar outcomes as patients finalizing planned treatment. First-line metastatic treatment with ipilimumab and nivolumab post-adjuvant anti-PD-1 did not show improved outcomes compared to ipilimumab/anti-PD-1 monotherapy.
Competing Interests: Declaration of Competing Interest Within the last two years: RJ has received travel/conference expenses from Pierre Fabre. MD has received proprietary data access from Bristol Myers Squibb and Genentech and is an advisor of Achilles Therapeutics. CR reports grants from Novo Nordisk Foundation and Helsinn Healthcare SA, and personal fees from Bristol-Myers Squibb, Helsinn Healthcare SA, and Pharmanovia, outside the submitted work. CAH has received honoraria for lectures from BMS and GSK. IMS has received honoraria for consultancies and lectures from IO Biotech, Novartis, MSD, Pierre Fabre, BMS, Novo Nordisk, TILT Bio; research grants from IO Biotech, BMS, Lytix, Adaptimmune, and TILT Bio. EE received honoraria from BMS, Pierre Fabre, and Novartis for consultancies, lectures, and travel/conference expenses from Pierre Fabre and MSD. No potential conflict of interest was reported by the other author(s).
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