I’m presenting data in a study in relapsed refractory large cell lymphoma with lenalidomide and a CD19 antibody.
What was the rationale of putting these two together?
Both of them have single-agent response rates in relapsed refractory large cell lymphoma and have been pretty well tolerated. The responses have been modest, about 30% with either agent alone. There is some pre-clinical data that lenalidomide can activate NK-cells and that can help the morphosis antibody work. There is preclinical data in CLL and lymphoma so it was thought that there could be synergy with the two compounds. They’ve been well tolerated and are being studied in a relapsed refractory population that’s not eligible for transplants so not eligible for aggressive therapy and doesn’t have a lot of options.
You mention they are well tolerated, what kind of profile are we looking at here?
The most common toxicities have been hematologic, so cytopenias. Most of them have been grade 1 to 2. There has been about 40% of patients who have grade 3 to 4 neutropenia. But really when you look at the profile it’s not much different than single-agent lenalidomide alone, so not much added toxicity from the antibody.
And when it comes to endpoints for the trial are we looking at disease control, progression?
Yes, so the primary endpoint of the trial was overall response rate. Secondary endpoints are progression free survival, overall survival and then we are doing some correlative studies to look at cell of origin, what type of large cell, if it’s active in both ABC and GCB or if one preferentially. And then some immune subsets to see if there really is benefit from the NK activation.
What results can we report so far?
We are going to report a 56% overall response rate with the combination including a 32% complete response rate and an additional 12% of patients who have had stable disease. Currently we have five patients who are reaching being on trial for a year or longer and sixteen out of nineteen patients have ongoing responses. So thus far while it’s early the results do seem to be durable in those patients who’ve responded.
You mention this wasn’t for aggressive cases but how would this play alongside/ We have heard from other combinations at the conference looking at cyclophosphamide and dexamethasone with lenalidomide, would you say that the antibody would be more suitable for any one patient subgroup or is it just part of the armamentarium at this point?
Right now, if you look at it we’re seeing responses similar to what you would with salvage chemotherapy, although the patient population in the trial was those not eligible for transplant. I think one of the next steps might be to look at it. Is it just as effective in a younger or more refractory population? But any older patient that’s relapsed after initial therapy is a great candidate for this and overall it’s probably less toxic. But similar responses, like I said, to even aggressive chemo in these patients.
We will follow patients until they progress. Right now we have 44 of the 80 planned patients enrolled so we are expecting by probably this time next year we should be able to report overall response rate with first response assessment which occurs two months after starting trial. So we should have our primary end point hopefully within a year.
That will that be coming to EHA 2018 or ASH perhaps?
We’ll probably come to ASH, we probably won’t have the total overall, all the patients enrolled and ready for ASH but by EHA next year we should be able to have everything for the primary end point.