medwireNews: Patients with resected stage IIIB–IV melanoma derive a significant recurrence-free survival (RFS) benefit from adjuvant treatment with nivolumab versus ipilimumab, interim results from the CheckMate 238 trial indicate.
The programmed cell death protein 1 (PD-1) inhibitor also has “a superior safety profile,” Jeffrey Weber (New York University Langone Medical Center, USA) told the attendees at the ESMO 2017 Congress, held in Madrid, Spain.
Among the 906 patients with completely resected disease included in the phase III trial, the 453 given nivolumab 3 mg/kg every 2 weeks had a significant 35% reduced risk for recurrence compared with their 453 counterparts treated with ipilimumab 10 mg/kg every 3 weeks for four doses and every 12 weeks from week 24.
The 12-month RFS rates were 70.5% and 60.8%, respectively, while at the 18-month mark a respective 66.4% and 52.7% were free of recurrence.
Weber reported that patients derived an RFS benefit from nivolumab regardless of programmed cell death ligand 1 status (≥ vs <5%), and that nivolumab was favored across all other predefined subgroups as well, such as age, gender, disease stage, and BRAF mutation status.
He added that the safety profile “clearly indicates a clinically significant benefit” for nivolumab over the cytotoxic T-lymphocyte associated antigen 4 inhibitor by any criteria. For instance, treatment-related side effects of grade 3 or 4 occurred in 14.4% of nivolumab-treated participants compared with 45.9% of those given ipilimumab, and led to treatment discontinuation in 4.6% and 30.9%, respectively.
The incidence of immune-related adverse events was in general lower in the nivolumab than ipilimumab arm, with the exception of low-grade thyroid disorders, which occurred more often in nivolumab-treated patients (20.4 vs 12.6%).
None of the deaths in the nivolumab arm were deemed related to treatment, whereas the ipilimumab group had two treatment-related deaths, one case each of marrow aplasia and colitis, both occurring more than 100 days after the final dose.
Based on these results, Weber concluded: “Nivolumab has the potential to be a new standard treatment option for patients with resected stage IIIB, IIIC, and IV melanoma regardless of BRAF mutation.”
These results were simultaneously published in The New England Journal of Medicine.
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