My name is doctor Mark Litzow. So I am a hematologist at the Mayo Clinic in Rochester, Minnesota. And I want to tell you today a little bit about a clinical trial that I led using blinatumomab.
Blinatumomab is a bispecific T-cell engaging molecule that takes the variable region of an antibody that reacts with a protein on B-cell acute lymphoblastic leukemia cells called CD19. And it's linked to an antibody that reacts with a protein on some immune cells called T cells or thymocytes. And it brings the T-cell in close proximity to the leukemic cell and kills it.
This was actually developed about ten years ago and was found to be beneficial in patients where their leukemia, unfortunately, had come back after chemotherapy, and it was found to be effective in that setting. Then we also studied it in patients where they had low levels of leukemia, what we call measurable residual disease, and it was found to be beneficial there.
So in this clinical trial that I did, we added it to chemotherapy in patients who we thought had a good prognosis. They were in remission and their measurable residual disease testing was negative. So they were MRD negative.
We enrolled 488 patients, and they went through several months of chemotherapy to get into remission. And then at that point, if they were measurable residual disease or MRD negative, we randomized them to either continue with what we call consolidation chemotherapy to consolidate their remission, or we added blinatumomab to the consolidation chemotherapy.
Blinatumomab has to be given by intravenous infusion daily for four weeks. That’s one cycle. So it's a month of treatment. Then they get a two-week break and get another month. And then we give four cycles of this blinatumomab.
What we found was that the patients who got blinatumomab with chemotherapy had a much better survival than the patients that got the chemotherapy alone. At three years, survival was 85% for the patients who got blinatumomab with chemotherapy and 68% for the patients that got chemotherapy alone.
As a result of this, the FDA approved blinatumomab now for MRD negative patients. They kept the indication broad and said it could be added to consolidation chemotherapy.
I'm here at the European Hematology Association meeting in Milan, Italy. We’re presenting some data from a subset of patients from that study. These were the younger patients on the study because we enrolled patients between the ages of 30 and 70 on this clinical trial, the E1910 trial.
So at this meeting, we're looking at the patients that were between the ages of 30 and 55. We found that particularly in these younger patients, blinatumomab was very effective. At three years, their survival was 92% versus 67% for patients that got chemotherapy. We also looked at the patients between the ages of 30 and 40, and they had 100% survival with blinatumomab, versus about 70% for the patients that got chemotherapy.
We’re very encouraged by these results. We think this is going to allow us to use more immune therapy medications like blinatumomab and some other ones, and allow us to reduce the amount of chemotherapy we give in the hopes that we can lessen some of the side effects that patients experience and yet continue to improve their remission rate and survival.