This is a phase III trial where we have randomised patients with metastatic melanoma for first-line therapy either participating in the group of patients only receiving the anti-PD-1 antibody or having an immune modulatory vaccine on top of the anti-PD-1 antibody. Our findings were that it seems that we can actually benefit the patient by adding on this immune regulatory vaccine and what we found was that we had a PFS of 19 months as compared to 11 months in the control group. But we didn’t reach the significance level of 0.045, we had a p-value of 0.056. But when we looked into subgroups of poor prognosis like the PD-L1 negative patients we did see a significantly better progression free survival when we added on the vaccine.

Were there any adverse events?

No, and that is a very important issue, actually because normally when you add or you combine checkpoint inhibitors you severely increase the risk of serious side effects. But in this case we only saw mild local reactions where we injected the vaccine, we didn’t have any additional systemic side effects.

What could be the implications of these findings?

The implications, as I see it, this could be a very good alternative to the combination checkpoint inhibitors for patients, specifically the PD-L1 negative patients who are the patients who are really difficult to treat.

What are the next steps?

What is going on at the moment from the company side is that they are considering planning a new phase III trial where they actually want to try to test this immune modulatory vaccine towards PD-L1 and IDO in combination with two different checkpoint inhibitors.