I’m here at EHA in Madrid presenting some data from the Myeloma XI study looking at the comparison between two different triplet induction regimens for transplant-eligible myeloma patients. One triplet containing the immunomodulatory agent drug thalidomide combined with cyclophosphamide and dexamethasone and one containing lenalidomide combined with cyclophosphamide and dexamethasone.
We also have data looking at the subsequent randomisation for these patients post-autologous stem cell transplant comparing lenalidomide maintenance to no maintenance. And therefore, we are also able to look at the interaction of lenalidomide given as induction and also as maintenance.
Let’s start off with the induction data, was there any separation between the arms there?
The lenalidomide-containing triplet induced deeper responses than the thalidomide-containing triplet and this translated into a progression free survival and overall survival benefit.
And then as maintenance?
The maintenance data which we initially presented at the American Society of Hematology just before Christmas demonstrated a significant benefit for lenalidomide over observation in transplant eligible patients. And when we look at the interaction between those patients who had lenalidomide as induction and also as maintenance, those patients who had lenalidomide at both time points did better than any others throughout the trial.
Could you tell us more about the benefit?
The lenalidomide-containing triplet prolonged median progression-free survival by three months but demonstrated a significant benefit and this also translated into an overall survival benefit.
You mentioned this coming out at ASH last year, are there any plans for further follow up at ASH this year?
At the moment we have progression free survival data for the maintenance analysis which compares lenalidomide to observation and we hope to have overall survival data for this randomisation later this year.
I guess lenalidomide taking the place of thalidomide, would you recommend that as standard of care going forwards based on this data or should we wait for the overall survival?
In terms of maintenance therapy our data supplements previous studies that suggest the lenalidomide is more effective than observation or placebo in terms of maintenance therapy. Previous studies have looked at using thalidomide as maintenance and there was some evidence of efficacy in this setting but the thalidomide was generally not well tolerated and patients were not able to stay on therapy for long periods of time. Lenalidomide has the benefit that it is better tolerated by patients and therefore patients are able to stay on therapy and in our study they stayed on therapy until disease progression.
This was a comparison of the two triplets and then there is also some quadruplet study in the Myeloma XI trial, can you tell us more about that?
In addition to the comparison between the immunomodulatory triplets there is a subsequent amendment to the study that added a comparison between these two triplet therapies and a quadruplet therapy combining carfilzomib, cyclophosphamide, lenalidomide and dexamethasone. At the moment we have response data for this randomisation and these results that I am presenting on Sunday demonstrate even deeper responses achieved with the quadruplet therapy compared to either of the triplet therapies.
I don’t suppose there is any mention of what that might mean for PFS or OS for that group as well?
We are waiting for progression-free survival data for this cohort of patients which we hope to have towards the end of this year.