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Avelumab real-world use in advanced Merkel cell carcinoma: a systematic review and non-comparative meta-analysis
Andreas Freitag1, Zhiyi Lan2, Hoora Moradian2
1Evidence, Value & Access, Cytel, Inc., London, UK.
Aim:
Programmed death (ligand) 1 inhibitors (e.g., avelumab, pembrolizumab, and retifanlimab) are first-line treatment options for patients with locally advanced or metastatic Merkel cell carcinoma (MCC). In the absence of comparative and randomized trials, we aimed to systematically identify and synthesize real-world evidence (RWE) on the effectiveness and safety of immunotherapies in patients with advanced MCC.
Methods & Materials:
MEDLINE and Embase searches were conducted for observational RWE studies in locally advanced or metastatic MCC from January 2017 to December 2023. Avelumab was the only immunotherapy with sufficient data for analysis. Landmark 12-month overall survival (OS) and progression-free survival (PFS) were assessed by meta-analysis.
Results:
Screening of 1731 records identified 37 publications eligible for inclusion (16 unique studies), of which eight were included in the meta-analysis. In line with results from the JAVELIN Merkel 200 trial, pooled 12-month OS rates of 77.7% in stage III and 63.0% in stage IV MCC and 12-month PFS rates of 53.3% and 39.3%, respectively, were estimated. Although safety data were insufficient for meta-analysis, two retrospective studies reported lower adverse event rates than JAVELIN Merkel 200.
Conclusions:
The results of this study support broader use of avelumab in advanced MCC.
Insights
Real-world evidence shows avelumab offers significant survival benefits for advanced Merkel cell carcinoma (MCC). This immunotherapy demonstrated strong 12-month overall survival and progression-free survival rates in patients with MCC.
Area of Science:
- Oncology
- Immunotherapy
- Real-World Evidence
Background:
- Programmed death (ligand) 1 inhibitors are first-line treatments for advanced Merkel cell carcinoma (MCC).
- Limited comparative trials necessitate real-world evidence (RWE) synthesis for advanced MCC immunotherapies.
Purpose of the Study:
- To systematically identify and synthesize RWE on the effectiveness and safety of immunotherapies in advanced MCC.
- To evaluate real-world outcomes for patients with locally advanced or metastatic MCC receiving immunotherapy.
Main Methods:
- Searched MEDLINE and Embase for observational RWE studies (Jan 2017-Dec 2023) on advanced MCC.
- Conducted a meta-analysis of 12-month overall survival (OS) and progression-free survival (PFS) for avelumab.
- Assessed safety data from included retrospective studies.
Main Results:
- Avelumab was the only immunotherapy with sufficient data for meta-analysis.
- Pooled 12-month OS rates were 77.7% (Stage III) and 63.0% (Stage IV) MCC.
- Pooled 12-month PFS rates were 53.3% (Stage III) and 39.3% (Stage IV) MCC.
Conclusions:
- Real-world data support the effectiveness of avelumab in advanced MCC.
- Avelumab demonstrates comparable survival outcomes to clinical trial data.
- Safety profile in real-world settings appears favorable, warranting broader use.
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