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JAVELIN Merkel 200 showed that the PD-L1 antibody avelumab shrinks about a third of Merkel cell carcinomas that have already failed chemotherapy, most of them durably, and it produced the first approved drug for this cancer.
JAVELIN Merkel 200 was a single-arm phase 2 trial of avelumab in metastatic Merkel cell carcinoma, a rare, aggressive neuroendocrine skin cancer driven either by Merkel cell polyomavirus or by ultraviolet mutation, both of which make it visible to the immune system. Part A enrolled patients whose disease had progressed after chemotherapy; part B enrolled untreated patients.
In part A the objective response rate was 31.8 percent in 88 patients (Lancet Oncology 2016), and responses were durable where chemotherapy responses had typically lasted only months. In part B, in 116 untreated patients, the response rate was 39.7 percent with long follow-up.
Avelumab received accelerated approval in March 2017, the first drug ever approved for Merkel cell carcinoma, and with KEYNOTE-017 (pembrolizumab) it made PD-1 pathway blockade the first-line standard for advanced disease.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
204 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (part A, after chemotherapy)primary | Avelumab | 88 | 31.8% | - | - | link |
| Objective response rate (part B, first line) | Avelumab | 116 | 39.7% | - | - | link |
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.
This is the paper Europe PMC returns for registry id NCT02155647 with the most citations, so it is the natural first reading for anyone following the JAVELIN Merkel 200 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares ADMEC-O (adjuvant nivolumab in completely resected Merkel cell carcinoma), POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma), Oncogenic viruses, Merkel cell carcinoma.
Shares ADMEC-O (adjuvant nivolumab in completely resected Merkel cell carcinoma), POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma), Merkel cell carcinoma, Skin cancer (all types).
Shares ADMEC-O (adjuvant nivolumab in completely resected Merkel cell carcinoma), POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma), Avelumab, Merkel cell carcinoma.
Shares Avelumab, Merkel cell carcinoma, Skin cancer (all types).
Shares Avelumab, Pfizer (incl. Seagen), Immune checkpoint inhibitors.
Shares Avelumab, Pfizer (incl. Seagen), Immune checkpoint inhibitors.
Shares POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma), Oncogenic viruses, Merkel cell carcinoma, Skin cancer (all types).
Shares Avelumab, Immune checkpoint inhibitors.