Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial

The Role of Neoadjuvant Immunotherapy in the Management of Merkel Cell Carcinoma with Clinically Detected Regional Lymph Node Metastasis

“…Because MCC is a particularly profoundly immunogenic tumor, the role of immunotherapy is strongly suggested in clinical studies, particularly in the adjuvant or metastatic setting of MCC, including the KEY-NOTE-017 trial, 21 the JAVELIN Merkel 200 trials, 22,23 and the ADMEC-O trial. 24 The KEYNOTE-017 study was a 2016 phase 2 trial that demonstrated a 56% complete or partial response rate during a median of 33 weeks of followup evaluation for patients who received at least one dose of pembrolizumab as first-line treatment for advanced MCC, with a 3-year overall survival of 90% for responders. 21,25 The JAVELIN Merkel 200 trials, also published in 2016, demonstrated a 33% response rate for patients with metastatic MCC that progressed on chemotherapy treated with avelumab.…”

“…23 The ADMEC-O trial, published in 2023, evaluated adjuvant nivolumab with an 84% disease-free survival rate for the patients in the immunotherapy group versus 73% for the control group during 24 months of follow-up evaluation. 24 However, the Checkmate 358 trial is the only published trial to date that evaluated nivolumab in the neoadjuvant setting for MCC. 14 The patients with stages IIA to IV resectable disease received two doses of nivolumab followed by definitive surgery.…”

“…25 In the ADMEC-O trial, treatment-related adverse events occurred for 74% of the patients in the nivolumab group. 24 Furthermore, in the Checkmate 358 trial, three patients (7.7%) receiving NIO ultimately did not undergo surgery despite enrolling with resectable disease due to tumor progression or adverse events. 14 It should be noted that the patients in our study had higher 5-year OS rates in both the NIO (57%) and no NIO (44%) groups than in other studies of MCC patients with CDRLNM, such as the widely cited 5-year OS rates of 26% to 42% for clinically detected regional lymph node metastasis from the American Joint Committee on Cancer (AJCC).…”

Localized Merkel cell carcinoma treatment considerations: a response to the forty-year experience at the Peter MacCallum cancer centre

“…Of note, avelumab is only indicated in metastatic disease (stage IV) in Australia at the time of writing; however, the I-MAT study is investigating the efficacy of avelumab for stage I-III MCC [ 2 ]. Existing immunotherapy trials include the ADMEC-O trial (NCT02196961) which is investigating the efficacy of adjuvant nivolumab monotherapy in patients with completely resected MCC [ 6 ]. Other trials include America’s ADAM trial which investigates the efficacy of avelumab for regional disease that has spread to the lymph nodes [ 7 ], and the STAMP clinical trial which investigates the efficacy of adjuvant pembrolizumab after surgery for stage I-III disease [ 8 ].…”

Incidence and Relative Survival of Patients with Merkel Cell Carcinoma in North Rhine-Westphalia, Germany, 2008–2021

“…Radiation therapy targeting the tumor bed and the draining lymph node region is frequently used as an adjuvant treatment. More recently, adjuvant immunotherapy with immune checkpoint inhibitors (ICIs) has been shown to improve progression-free survival [ 4 ]. Moreover, ICIs have revolutionized the treatment landscape for advanced MCC.…”