Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database

Merkelcell.org Summary

Avelumab is a type of immunotherapy, a drug that helps the immune system fight cancer. It is often used to treat Merkel cell carcinoma (MCC) that has spread, called metastatic MCC. The first treatment given to fight cancer is called the first-line treatment, and if that doesn’t work, doctors try a second-line treatment or beyond. This study looked at how well avelumab worked as a second-line treatment (or beyond) for MCC. In France, 180 patients who had already tried another first-line treatment, usually chemotherapy, were given avelumab. The study found that 54% of these patients were still alive after one year, and 40% after two years. Also, 55% of the patients had a positive response to the treatment, with 32% having their cancer fully respond. These results support the results of previous clinical trials and show that avelumab can be an effective treatment for metastatic MCC, even when it’s not the first treatment used. However, it is important to note that because of its effectiveness and long-lasting benefit, guidelines recommend using immunotherapy as a first-line treatment whenever possible.

For more, see the following for a previous summary on a clinical trial for first-line avelumab: First-line avelumab treatment in patients with metastatic Merkel cell carcinoma: 4-year follow-up from part B of the JAVELIN Merkel 200 study – Merkel Cell Carcinoma

Abstract

Aim
Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice.
Methods
This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.
Results
Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %.
Conclusions
Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.