Long-term clinical evidence of comparable efficacy and toxicity of nivolumab and pembrolizumab in advanced melanoma treatment

Abstract

Pembrolizumab and nivolumab (anty-PD-1 antibody) are commonly used for the treatment of melanoma patients. However, their efficacy and safety have never been directly compared, leaving little guidance for clinicians to select the best therapy. The study included patients with inoperable or metastatic melanoma treated in first line with anti-PD-1 immunotherapy (nivolumab or pembrolizumab). In total 1037 patients were enrolled in the study, 455 (44%) patients were treated with pembrolizumab and 582 (56%) with nivolumab. The estimated median overall survival (OS) in the pembrolizumab and nivolumab groups was 17.4 and 20.0 months [P = 0.2323; hazard ratio (HR), 1.1; 95% confidence interval (CI), 0.94–1.28], respectively, whereas the median progression-free survival (PFS) was 5.6 and 7.5 months (P = 0.0941; HR, 1.13; 95% CI, 0.98–1.29), respectively. The estimated 2- and 3-year OS in the pembrolizumab and nivolumab groups were 42/34% and 47/37%, respectively, and the PFS was 25/21% and 29/23%, respectively. There were 391 (49%) immune-related adverse events (irAEs) of any grade during treatment, including 133 (42%) related to pembrolizumab treatment and 258 (53%) to nivolumab treatment. A total of 72 (9.6%) irAEs were in G3 or G4, including during pembrolizumab 29 (9%) and nivolumab 48 (11%). There were no differences in OS, PFS and overall response rates between nivolumab and pembrolizumab therapy in previously untreated patients with advanced/metastatic melanoma. There were no differences in the frequency of G1/G2 or G3/G4 irAEs. The choice of treatment should be based on the preferences of the patient and the clinician.

Efficacy of Pembrolizumab in Advanced Melanoma: A Narrative Review

“…The results of this study showed that the median OS was 17.4 months for pembrolizumab and 20 months for nivolumab, while the estimated OS at 2 and 3 years was 42/34% for pembrolizumab and 47/37% for nivolumab. The differences in the OS, PFS, and overall response were not statistically significant in naive patients with metastatic melanoma, confirming the clinician's role in the treatment choice [38].…”

Therapeutic and Adverse Effect of Anti-PD1 Immunotherapy in Melanoma: A Retrospective, Single-Institute Study of 222 Patients

“…Since, in the literature, the majority of the available data demonstrated the results of clinical trials, the outcomes of melanoma patients that were treated in "routine" healthcare systems may add valuable details to assess the efficacy of immunotherapy. The clinical work of Cybulska-Stopa et al enrolled 1037 patients with metastatic melanoma; 44% of the patients were treated with pembrolizumab and 56% with nivolumab [15]. They found more prolonged overall and progression-free survival among the nivolumab group; however, the difference was not statistically significant.…”