We are presenting a clinical phase I/II trial, it’s the second arm from that trial. In this study we are treating patients with pancreatic cancer with a new tumour microenvironment gene-engineering treatment together with chemotherapy and a checkpoint blockade antibody.

What was the study design?

It is an open label study and, as I said, it is a phase I/II. It was actually first in human design so we have a dose escalation in the beginning testing three different dose levels. At that stage we had our product, LOAd703, together with chemotherapy, and then we went on to a second arm where we had a dose escalation with the two highest doses. Then we added also this checkpoint blockade antibody. It was a 24-patient study in the end and at the two highest dose levels with the checkpoint we had 12 patients per dose.

What were the key findings?

In this study we could see that it was safe and feasible where the LOAd703 product is given intratumourally. So first of all we wanted to know that that was safe and we could see that it was tolerable. Of course you have the side effects that you can expect from chemotherapy and also a checkpoint blockade antibody but in terms of LOAd703, which is a viral product, we could see some fever, nausea, fatigue, headaches and so on, and that occurred rather rapidly – within the first hours, I would say – like in any other vaccination type of side effects.

Then, of course, this is not a study with a control arm so it’s difficult to discuss results but what we can say is that we had a higher overall response rate than we expected – it was 38%. If we looked at only the first-line treated patients, because here you could be first line, second line or even beyond, if you look at only the first-line treated patients we had a 54% overall response rate.

Also we know that survival in this rather heterogeneous group of pancreatic patients was 9.9 months and, again, looking at the first-line patients it was 14.7 months. So it looks like this treatment is giving an enhanced effect but, of course, that needs to be tested later in randomised studies.

Is there anything else you would like to add?

We saw some complete responders in this study. They were radiologically confirmed and some of them were rather durable – 2½ years, 1½ years, and so on, which is rather unusual in this patient group. Maybe that is because we managed to activate an immune response that maybe can control the tumour. If you enable it to be under control you can also control it for a longer time than if you give chemotherapy, then the effect is lost when you stop treating the patient. But, again, we need to investigate this in randomised studies but it was very promising to see these results and it has prompted us to design, now, a phase II/III trial which will be our next step.