My presentation was about a randomised phase II trial that we are performing in Sweden and the Nordic countries which is about early-stage disease. The patients received SBRT and then they were randomised to durvalumab or just follow-up.

What was the study design?

It’s an open-label randomised phase II trial and randomised 1:1. The first group received standard radiation, you can say that it’s standard practice for patients that do not get surgery; they are not fit for surgery so they get SBRT instead. The other group received the same radiation and then durvalumab for one year given once monthly.

What were the key findings?

The primary endpoint was time to progression and we could show that it was a significantly longer time to progression in the durvalumab group and fewer patients with progression in that group as well. That is the main result so actually the study met its primary endpoint. However, we still don’t know if this effect is meaningful for patients as the disease-free survival and overall survival were without a difference between the groups. The trial is not powered for showing a difference in overall survival. So we don’t know if it’s meaningful for the patients but it’s a signal of efficacy by the combination of SBRT and durvalumab.

What types of toxicities did you observe?

We could see a quite high number of low-grade toxicities – skin reactions and pruritus and fatigue but it was manageable and there were very few grade 3 events.

What are the next steps?

The next for our study will be to go really deep into causes of death and relapse pattern and see if we could find any potential predictive factors that are associated with progression.

What do you think could be the importance of the study?

As I said, it’s a signal of efficacy of this combination but we don’t know yet if it’s something that can be used in daily practice. We are waiting the results of larger trials.