This is a clinical trial that attempts to answer the question about activity of pomalidomide in patients who are relapsing on lenalidomide. One of the preconceived notions about people who are progressing on specific therapies in multiple myeloma is that you need to change the group of drugs, the class of drugs. So if somebody is progressing on a proteasome inhibitor you don’t want to go to a different proteasome inhibitor; if somebody is progressing on an IMiD you don’t want to continue on an IMiD based therapy. This is despite the fact that, particularly with pomalidomide, that the early clinical data, the data that led to the initial approvals of pomalidomide by the FDA in the United States did not seem to show that refractoriness to lenalidomide was a major issue; response rates were very, very similar. This is a trial that is taking patients who are progressing on lenalidomide and moving them directly to pomalidomide. This sort of confirms that kind of notion, so the idea that we need to skip, we need to go on to something else and then come back to an IMiD at a later date isn’t really the reality of the situation. These drugs are different enough that they can stand the class kinds of refractoriness.
What are the implications?
It may change how we manage patients, particularly in the United States where so many patients are on lenalidomide maintenance therapy. This may change worldwide now because lenalidomide maintenance is now at least technically approved in Europe, I don’t know whether it’s reimbursed. So you see a lot of patients who are progressing on low doses of lenalidomide and this natural inclination to say, ‘OK, we’ve got to jump to some other style of therapy,’ is not necessarily substantiated by the data. So it’s going to be an important observation given the current treatment environment.