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. 2021 Apr;70(4):1031-1036.
doi: 10.1007/s00262-020-02756-9. Epub 2020 Oct 26.

Merkel cell carcinoma in Latin America: a contribution from an expanded access program for avelumab to address issues from experts' recommendations

Rodrigo Ramella Munhoz  1 , Federico Cayol  2 , Luis Corrales  3 , Raquel Gerson  4 , Malena Tilli  5 , Elluz Oliver Barreto  6 , Jesús Oswaldo Sánchez Castillo  7 , Rafael Aron Schmerling  8 , Gabriela Cinat  9
Affiliations

Merkel cell carcinoma in Latin America: a contribution from an expanded access program for avelumab to address issues from experts' recommendations

Rodrigo Ramella Munhoz et al. Cancer Immunol Immunother. 2021 Apr.

Abstract

Background: Merkel cell carcinoma (MCC) is an aggressive malignancy, associated with poor outcomes in patients with metastatic disease (mMCC). Management has been dramatically altered as a result of incorporating immune checkpoint blockade agents. MCC data from Latin America (LATAM) come from case-series or individual records. Regional registries are lacking. A need for better registries to improve current knowledge about MCC is highlighted. Our objectives were to describe a real-world experience with avelumab as a second-line (or first-line in unfit patients) treatment in a subset of LATAM participants enrolled in a global Expanded Access Program (EAP) for patients with mMCC, and to evaluate its contribution to the resolution of the concerns described in a recent regional experts review.

Materials and methods: We reviewed data of LATAM participants in an avelumab EAP for mMCC treatment (NCT03089658). EAP patient had unresectable or mMCC with progressive disease after one line of chemotherapy, and were ineligible for clinical trials or unfit for chemotherapy.

Results: 46 patients (median age: 71.6 years; 60.9% males; median treatment duration: 7.9 months) were included in the LATAM EAP. Physician-assessed objective responses were available for 19 patients. Complete response rate was 15.8% and partial response rate reached 42.1%, summarizing an objective response rate of 57.9%. Stable disease rate was 10.5%, with a disease control response of 68.4%.

Conclusion: Avelumab showed robust efficacy and a safety profile consistent with global EAP data. Results are aimed to improve current knowledge about mMCC treatment and access to immunooncologic strategies for treating LATAM patients.

Keywords: Avelumab; Latin America; Merkel cell carcinoma; Skin cancer.

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Conflict of interest statement

Dr. Muhoz: Research involvement: BMS, Lilly, Merck, MSD, Novartis, and Roche. Honoraria: Bayer, BMS, Merck, MSD, Novartis, Roche, Sanofi. Travel grants: BMS, Novartis, Sanofi. Dr. Tilli is an employee of Merck SA, Buenos Aires, Argentina, an affiliate of Merck KGaA, Darmstadt, Germany.

Figures

Fig. 1
Fig. 1
Flowchart describing LATAM EAP participants (*) These subjects were deemed ineligible for chemotherapy and therefore approved for first line therapy (1L) with avelumab
See this image and copyright information in PMC

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