Efficacy and safety of nivolumab plus ipilimumab versus nivolumab alone in patients with advanced melanoma: a systematic review and meta-analysis

ABSTRACT

Background

Annual melanoma incidence in the US is escalating.

Objective

Comprehensive evaluation of nivolumab alone or with ipilimumab for advanced melanoma treatment.

Research design and methods

A systematic search was conducted across PubMed, Embase, Web of Science, and Cochrane databases, extending until August 2023. A range of outcomes were evaluated, encompassing overall survival (OS), recurrence-free survival (RFS), progression-free survival (PFS), disease-free survival (DFS), adverse events (both any and serious), complete response rate, mortality rate, and recurrence rate in patients with advanced melanoma.

Results

This analysis was conducted on seven relevant studies, involving 2,885 patients. The baseline characteristics of both groups were found to be comparable across all outcomes, with the exception of tumor size. The pooled analysis did not reveal any significant disparities, except for PFS, where the nivolumab-ipilimumab treatment group demonstrated a significantly longer PFS compared to the nivolumab group. However, there was a notable discrepancy in any adverse events (Odds Ratio (OR): 2.69; 95% Confidence Interval (CI): 1.96, 3.69; p < 0.00001) and serious adverse events (OR: 3.59; 95% CI: 2.88, 4.49, p < 0.00001) between the two groups, suggesting that the safety profile of nivolumab combined with ipilimumab was inferior.

Conclusions

Given diversity and potential biases, oncologists should base immunotherapy decisions on professional expertise and patient characteristics.

Registration

PROSPERO registration number: CRD42023453484.

KEYWORDS:

• Nivolumab
• ipilimumab
• melanoma
• meta-analysis
• nivolumab plus ipilimumab

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

S Cui, X Sun and J Gao conducted the research, contributed to data collection, and prepared the initial draft of the manuscript. Statistical analysis was performed by S Cui who also contributed to its design. X Sun and J Gao participated in data acquisition, analysis, interpretation, and manuscript preparation. The final version of the manuscript underwent review and approval by all authors.

Data availability statement

The data will be disclosed upon a legitimate inquiry.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737140.2024.2336106.

Additional information

Funding

This paper was not funded.