ECOG 1910, this was the large phase III study that was published in The New England Journal of Medicine. Basically the main outcome of this original study was showing that in patients that were MRD negative, minimal residual disease negative, after post-remission treatment, in patients with Philadelphia chromosome negative B-ALL, the addition of blinatumomab to therapy improved both event free and overall survival. So this is really about FDA approval of blinatumomab in the up-front setting and really has changed our standard of care.

So the main goal of this abstract was really to look at toxicities and see, now that this has become more widespread, the toxicity data has been previously published, but to take a deeper dive into the data. The main take-home points from this are with induction chemotherapy, so this was the part that was before patients received blinatumomab. This chemotherapy backbone was actually modified when the study was designed. What’s really interesting is if you look at the toxicity and compare it to the toxicities on one of the co-operative group young adult studies we did, there really was a lower incidence of various toxicities such as hyperglycaemia, liver transaminase and bilirubin elevation. So it suggests that this may be a nice backbone and particularly because this study included older patients.

Then the second part was looking at the patients that received blinatumomab. They may have had low blood counts during this time but really we didn’t see any increased risk of infections which was important. Generally the blinatumomab was tolerated well. If you looked at all neurologic and psychologic events there was a increased incidence in the blinatumomab arm but, again, if you look at grade 3 or grade 4 significant events that rate was very, very low.

Then we really looked at age and gender and number of cycles of blinatumomab received. Probably the main things that stood out is in patients that had a lower weight they maybe had more hematologic toxicity but, again, this didn’t correlate with any increased risk of infections or other complications. This may be due to the fact blinatumomab is a flat dose and not weight based.

Then patients who had more cycles maybe had  more cytopenias, but again these patients also had more chemotherapy. There were some other things that were trends and older patients potentially having a little bit more dysphasia and other things but, again, none of those were statistically significant.

So the main takeaway point is that blinatumomab was well tolerated.