{"entity":{"id":"paper-javelin-merkel-200-j-immunother-cancer-2018-update","kind":"paper","name":"Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial","aka":[],"tldr":"Later report from the JAVELIN Merkel 200 trial registered as NCT02155647, in Journal for ImmunoTherapy of Cancer (2018); its title describes an updated or longer-term analysis.","summary":"Background: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer associated with poor survival outcomes in patients with distant metastatic disease (mMCC). In an initial analysis from JAVELIN Merkel 200, a phase 2, prospective, open-label, single-arm trial in mMCC, avelumab-a human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody-showed promising efficacy and a safety profile that was generally manageable and tolerable. Here, we report the efficacy of avelumab after ≥1 year of follow-up in patients with distant mMCC that had progressed following prior chemotherapy for metastatic disease.\n\nPatients and methods: Patients received avelumab 10 mg/kg by 1-h intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was best overall response. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS).\n\nResults: Patients (N = 88) were followed for a minimum of 12 months. The confirmed objective response rate was 33.0% (95% CI, 23.3%-43.8%; complete response: 11.4%). An estimated 74% of responses lasted ≥1 year, and 72.4% of responses were ongoing at data cutoff. Responses were durable, with the median DOR not yet reached (95% CI, 18.0 months-not estimable), and PFS was prolonged; 1-year PFS and OS rates were 30% (95% CI, 21%-41%) and 52% (95% CI, 41%-62%), respectively. Median OS was 12.9 months (95% CI, 7.5-not estimable). Subgroup analyses suggested a higher probability of response in patients receiving fewer prior lines of systemic therapy, with a lower baseline disease burden, and with PD-L1-positive tumors; however, durable responses occurred irrespective of baseline factors, including tumor Merkel cell polyomavirus status.\n\nConclusions: With longer follow-up, avelumab continues to show durable responses and promising survival outcomes in patients with distant mMCC whose disease had progressed after chemotherapy.\n\nTrial registration: Clinicaltrials.gov identifier: NCT02155647.\n\nIndexed on Europe PMC as PubMed record 29347993 (DOI 10.1186/s40425-017-0310-x). Its abstract cites the registry id NCT02155647, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"J Immunother Cancer 2018","url":"https://doi.org/10.1186/s40425-017-0310-x"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29347993/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/29347993"},{"label":"ClinicalTrials.gov NCT02155647","url":"https://clinicaltrials.gov/study/NCT02155647"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["javelin-merkel-200"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jitc"],"dependsOn":[],"notes":[],"journal":"Journal for ImmunoTherapy of Cancer","year":2018,"doi":"10.1186/s40425-017-0310-x","pmid":"29347993","authors":"Kaufman HL, Russell JS, Hamid O, et al.","paperType":"observational","findings":[],"whatItMeans":"A second publication from the JAVELIN Merkel 200 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper."]},"route":"/key-papers/paper-javelin-merkel-200-j-immunother-cancer-2018-update/","neighbours":{"trial":[{"id":"javelin-merkel-200","kind":"trial","name":"JAVELIN Merkel 200","route":"/trials/javelin-merkel-200/"}],"journal":[{"id":"jitc","kind":"journal","name":"Journal for ImmunoTherapy of Cancer","route":"/journals/jitc/"}]}}