6ER-028 A comparative analysis of the efficacy of adjuvant treatment with pembrolizumab or nivolumab in patients with stage IIB/IIC melanoma

<h3>Background and Importance</h3> Patients with stage IIB/IIC melanoma have a comparable or elevated risk of recurrence and metastatic disease in comparison to those with stage III melanoma. Two drugs have recently been approved for adjuvant treatment. At present, there are no direct or indirect comparisons between existing treatments. <h3>Aim and Objectives</h3> The objective is to ascertain whether pembrolizumab and nivolumab can be designated as equivalent therapeutic alternatives (ETA) for patients with stage IIB/IIC melanoma through an indirect treatment comparison (ITC) adjusted using a common comparator. <h3>Material and Methods</h3> A literature search was conducted to identify phase III clinical trials (CTs) involving the use of pembrolizumab or nivolumab in similar patient populations, with comparable treatment durations and endpoints. The primary endpoint was recurrence-free survival (RFS) at 12 months. An ITC of pembrolizumab versus nivolumab was conducted using the Canadian Health Technology Agency’s Indirect Treatment Comparisons calculator, in accordance with the methodology proposed by Bucher. In accordance with the ESMO criteria, a hazard ratio (HR) &lt;0.65 (and its inverse, 1.54) was identified as a relevant indicator in the context of comparing treatments for the clinical scenario under consideration (delta value). Subsequently, the results were subjected to graphical analysis, with particular attention paid to the relative positioning of the 95% confidence interval (95% CI) and the equivalence margin. This was conducted in accordance with the ETA Guidelines. <h3>Results</h3> Two CTs were included in the ITC between pembrolizumab (KEYNOTE-716) and nivolumab (CheckMate-76K). The included CTs were: phase III, multicentre, randomised, double-blind, placebo-controlled and and the patients were older than 12 years with stage IIB/IIC melanoma. The results of each trial, as well as the ITC performed, are presented in table 1. The 95% CI exceeds the equivalence margin by more than 50%. <h3>Conclusion and Relevance</h3> In accordance with the ETA guideline, pembrolizumab and nivolumab cannot be considered ETA for adjuvant treatment of patients with stage IIB/IIC melanoma, as there could be a probably relevant difference. The 95% CI obtained is wide, reflecting the imprecise result for pembrolizumab, which would be a limitation of our study. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest