ZUMA-1 is a pivotal phase I/II trial and we are presenting the results from the phase II portion of this trial. The purpose of this trial is to look at a population of patients with refractory non-Hodgkin lymphoma who have very bad outcomes with current era treatment with a median overall survival of only 6.5 months, low response rate to treatment. We tested in our trial a novel treatment with CAR T that targets CD19 and in this trial we demonstrated that we have an 82% overall response and 54% complete response and this is seven times higher than the response rate seen, complete response rate seen, so far in this historical population. So that’s pretty impressive results.

We know with CAR T treatment in general we can see toxicities, particularly generally in the first month after treatment. Cytokine release syndrome and neurologic events are two treatments that are unique to CAR T and in this trial we showed that overall the incidence are relatively low at 13% for cytokine release syndrome, 28% for neurologic events and they’ve been generally manageable and reversible. In addition, in terms of feasibility, looking at moving this treatment into the clinical practice setting, we were able to make CAR T-cells for 99% of the patients, so pretty much of the 111 patients enrolled we were able to make product for everybody except one. The turnaround time from collecting their blood cells to when the CAR Ts are made and ship back to the treatment centre is only 17 days. So all of this makes it more likely to be feasible and hopefully something that will be very helpful for patients in this population.

It does sound like an absolute quantum leap in terms of the response you’re getting, the success with getting 99% of people treatable. There’s got to be something to take away from this silver lining, surely?

It is a product that is personalised so we need to make them from each individual patient and so we are certainly very excited about the clinical activities and the general feasibility. At this time the data are being reviewed at regulatory agencies so we need to see how to implement this into real practice. But we’re very optimistic in terms of being able to make this more accessible to patients. In particular, because of the toxicities that are different from what we see with conventional chemotherapy drugs or stem cell transplant, what we’ve seen in the trial is that for these multicentres that participated some of the centres are fairly new in experience with CAR T. But over the course of the trial the centres have gained more experience and initially in the interim analysis we saw maybe slightly higher incidences of these side effects but the events went down by the time we were doing the primary analysis. So the hope is that when this is ready to go into real practice, clinical practice, that this will be similarly manageable as we’ve seen in the trial as well.

This was for relapsed and refractory disease was it?

This is for, correct, non-Hodgkin lymphoma that are refractory, meaning that they did not respond to second line chemotherapy, are unable to get to stem cell transplant or who relapse after stem cell transplant.

Was there any difference in patient response depending on previous treatments, if there had been any IMiD course for example?

No, we looked across a number of variables that are known to impact outcome like the type of refractory, whether they were refractory to chemotherapy or stem cell transplant, the age of the patient, where the disease was involved, extra-nodal involvement and so on, and the response rate is the same across all of those.

Well it sounds like this is going to be making headlines very soon, as soon as the approval is sorted. Are there any plans for expansion cohorts or anything to take this forward whilst that review is ongoing?

At this time the data has been submitted to the regulatory agencies. We are waiting to hear their review. We do have an expanded access protocol that would be open, also in the US and in Europe, until we have more clear directions on moving forward into clinical practice.

That covers all of my questions, is there anything you want to offer by way of summary, conclusion, anything to wrap this up?

We’re just excited as I hope the audience when they hear about the clinical response and the general feasibility that we’ve seen in this trial so far.