Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East

Ascierto, Paolo A.; Orlova, Kristina V.; Grignani, Giovanni; Dudzisz-Śledź, Monika; Fenig, Eyal; Sileni, V. Chiarion; Fazio, Nicola; Samimi, Mahtab; Mortier, Laurent; Gebhardt, Christoffer; Kramkimel, N.; Steven, Neil; Bechter, Oliver; Arance, Ana; Benincasa, Elena; Kostkova, Lenka; Costa, Nuno; Lorigan, Paul

doi:10.1002/ijc.33746

Cited by 10 publications

(13 citation statements)

References 12 publications

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“…Again the most common AEs were infusion-related reaction reported in 2.4% of cases and pyrexia in next 2.1% of patients. No new toxicities were observed in this study [27]. Moreover in our real world study we enrolled 161 MCC patients who were treated with curative intent.…”

Section: Avelumab -Expanded Access Programmentioning

confidence: 79%

Avelumab use in Merkel cell carcinoma treatment

Dudzisz-Śledź

Zwierzchowska

Bylina

et al. 2022

Nowotwory. Journal of Oncology

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Section: Avelumab -Expanded Access Programmentioning

confidence: 79%

Avelumab use in Merkel cell carcinoma treatment

Dudzisz-Śledź

Zwierzchowska

Bylina

et al. 2022

Nowotwory. Journal of Oncology

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“…[6][7][8][9][10] While incidence data in Latin America and parts of Asia are scarce, multiple studies have shown that fair-skinned individuals have twice the risk when compared to the general population. 7,[11][12][13][14] Current studies have examined a wide range of populations, including the US, Latin America, the Netherlands, Italy, Israel, and the Middle East. A significant portion of these studies are supported by expanded access programs (EAPs).…”

Section: Demographicsmentioning

confidence: 99%

“…EAPs allow for the compassionate use of avelumab in patients in whom multiple chemotherapies have failed, surgery is not an option, and clinical trials are not accessible (secondary to immunosuppressed status). 11 The incidence of MCC peaks in the eighth decade of life likely due to higher cumulative UV radiation exposure and immunosenescence, both of which are risk factors for MCC. 15,16 The median age range in real-world studies ranges from 67.1 to 78 years.…”

Section: Demographicsmentioning

confidence: 99%

“…19,20 Patient demographics seen in real-world studies are described in Table 1. 3,9,[11][12][13][21][22][23] Although MCC is reported to occur predominantly on the head and neck, an analysis of 54 advanced MCC patients conducted in the Netherlands, indicated that tumors occurred on the trunk, head and neck, and extremities 15%, 24%, and 46% of the time, respectively. 21,24 In another study, primary tumor locations were lower limbs, lungs, and viscera, which metastasized to the lymph nodes 38%, 52%, and 68% of the time, respectively.…”

Section: Demographicsmentioning

confidence: 99%

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Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival

Lohray,

Verma,

Wang

et al. 2023

POR

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Introduction:Avelumab is a programmed cell death-ligand 1 (PD-L1) inhibitor approved by the Food and Drug Administration for advanced Merkel cell carcinoma (MCC). Studies conducted in real-world settings have shed light on its effectiveness and safety in clinical settings. Areas Covered: Real-world studies on avelumab for MCC from North and South America, Europe, and Asia have been presented in this review. Most studies are on patients over age 70 and have a male-predominant sex ratio. Overall response rates range from 29.1% to 72.1%, (disease control rate: 60.0-72.7%; complete response rate: 15.8%-37.2%; partial rate: 18.2-42.1%; stable disease: 7.1-30.9%; progressive disease: 7.1-40.0%) and median progression free survival ranges from 8.1 to 24.1 months depending on the population studied. Immunosuppressed patients appear to benefit from avelumab as well, with response rates equivalent to the general population. Patients receiving avelumab as a first-line agent tend to have better outcomes than those using it as a second-line therapy. Fatigue, infusion-related reactions, and dyspnea were some of the most common adverse events identified in real-world studies. Autoimmune hepatitis and thyroiditis were also observed. Conclusion:The use of avelumab as a safe and effective treatment option for advanced MCC is supported by real-world data, although additional study is required to assess long-term efficacy and safety outcomes.

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“…Meanwhile, the global avelumab program expanded access, which was designed to provide the compassionate use of avelumab prior to approval and led to similar response rates. The main treatment-related adverse events reported were infusion-related reactions and pyrexia [ 101 , 102 ].…”

Section: The Role Of Immunotherapy In Non-melanoma Skin Cancermentioning

confidence: 99%

Identifying Candidates for Immunotherapy among Patients with Non-Melanoma Skin Cancer: A Review of the Potential Predictors of Response

Zelin

Maronese

Dri

et al. 2022

JCM

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Background: Non-melanoma skin cancer (NMSC) stands as an umbrella term for common cutaneous malignancies, including basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), together with rarer cutaneous cancers, such as Merkel cell carcinoma (MCC) and other forms of adnexal cancers. The majority of NMSCs can be successfully treated with surgery or radiotherapy, but advanced and metastatic stages may require systemic approaches such as immunotherapy with immune checkpoint inhibitors (ICIs). Summary: Since immunotherapy is not effective in all patients and can potentially lead to severe adverse effects, an important clinical question is how to properly identify those who could be suitable candidates for this therapeutic choice. In this paper, we review the potential features and biomarkers used to predict the outcome of ICIs therapy for NMSCs. Moreover, we analyze the role of immunotherapy in special populations, such as the elderly, immunocompromised patients, organ transplant recipients, and subjects suffering from autoimmune conditions. Key messages: Many clinical, serum, histopathological, and genetic features have been investigated as potential predictors of response in NMSCs treated with ICIs. Although this field of research is very promising, definitive, cost-effective, and reproducible biomarkers are still lacking and further efforts are needed to validate the suggested predictors in larger cohorts.

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Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East

Cited by 10 publications

References 12 publications

Avelumab use in Merkel cell carcinoma treatment

Avelumab use in Merkel cell carcinoma treatment

Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival

Identifying Candidates for Immunotherapy among Patients with Non-Melanoma Skin Cancer: A Review of the Potential Predictors of Response

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