JAVELIN Merkel 200
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.
Overview
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.
- 31.8 out of 100 people had their tumour shrink with Avelumab.
- 39.7 out of 100 people had their tumour shrink with Avelumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Metastatic Merkel cell carcinoma: avelumab after chemotherapy (part A) and as first-line treatment (part B). People in a different situation may not see the same effect.
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 participants 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 |
Similar pages
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