Health Care

Dr. Weber on CheckMate-238 for Melanoma

The trial included 906 patients with stages IIIB, IIIC, and IV resected melanoma who had a greater than 50% risk of relapse over five years.

"Our results demonstrate that nivolumab is more effective in treating patients with stage III and IV melanoma, cutting the risk of relapse by a third", said Principal investigator Dr Jeffrey S. Weber, Professor of medicine at NYU School of Medicine and deputy director of Perlmutter Cancer Center. "This shows the magnitude of benefit is impressive, and that this is the real deal". Ipilimumab is also the Food and Drug Administration (FDA)-approved standard of care adjuvant therapy for resected stage III melanoma in the US.

Another anti-PD-1 drug, pembrolizumab, is being tested as adjuvant therapy against placebo in patients with resected stage III melanoma in a phase III European Organisation for Research and Treatment of Cancer (EORTC) trial.

The majority (81%) of patients had stage III disease, 32% had ulcerated primary melanoma, 48% had macroscopic lymph node involvement and 42% harbored BRAF mutations.

After 12 months of continuous therapy, 71% of patients treated with nivolumab lived without recurrence of the disease, compared with 61% of those treated with ipilimumab. RFS in the intent-to-treat population served as the primary endpoint.

Median follow-up was 18.5 months. There were similar results across prespecified subgroups of patients.

OS served as a secondary endpoint. He also says that more studies are needed to examine why some patients relapse following treatment and others do not. The study observed treatment-related grade 3 or 4 adverse events in 14.4% of the patients in the nivolumab group compared to 45.9% in the ipilimumab group.

"To me, as a clinician, that is really the most practical issue when administering adjuvant therapy", Weber said during a press conference. Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone. "Compared with the high toxicity of ipilimumab, it is much more tolerable for the patients".

Although adjuvant nivolumab after resection may benefit more patients with high-risk disease, several interesting questions arise, Weber said.

"The safety of nivolumab is very promising", Dr Weber added. "The concern about BRAF/MEK is it clearly induces resistance".

John Haanen, PhD, head of the division of medical oncology at Netherlands Cancer Institute, called the CheckMate 238 findings exciting.

Serious treatment-related adverse events (AEs) were reported in 59% of the patients in the nivolumab-plus-ipilimumab group, 21% in the nivolumab group, and 28% in the ipilimumab group.

The benefit shown for nivolumab in metastatic disease and those pilot data provided the impetus for CheckMate 238, a randomised, double-blind, phase III trial comparing adjuvant treatment with nivolumab versus standard of care ipilimumab.

2 Weber J, Mandala M, Del Vecchio M, et al.

Disclosures: Bristol-Myers Squibb funded this study. Please see the abstract for a list of all researchers' relevant financial disclosures.

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