DocWire News sat down with Natalie Callander, MD, professor and director of the Myeloma Clinical Program at the University of Wisconsin Carbone Cancer Center, about the recent FDA approval of melphalan flufenamide (melflufen) for the treatment of relapsed/refractory multiple myeloma.
DocWire News: The FDA recently approved the use of melphalan flufenamide (melflufen) for the treatment of RRMM. How do you see this approval impacting the multiple myeloma (MM) treatment landscape?
Dr. Callander: Well, I think we’re very excited about this approval. Melphalan, the parent drug of melflufen, has been around for a long time. It’s probably one of the oldest drugs we use for the treatment of myeloma, but this novel delivery method that allows the melphalan to enter the cells and then be cleaned off by these endopeptidases, so that there may be a better delivery of melphalan to the cells, I think is really exciting. And what I think is the response rate in these patients who’ve received more than four lines of therapy is pretty impressive, it’s about 25%. But I think even more exciting is the mechanism of delivery of the drug, which is a once-a-month IV infusion. I think patients are going to be very happy about that—about limited time coming to clinic. And I think also we’re very excited about the combinations that are going to be tested with melflufen.
DW: What other treatments are in the pipeline that you are hoping to see approved in the near future?
Dr. Callander: I think the BCMA-targeted drugs (B-cell maturation antigen) is one of the most important targets, we think, in myeloma. And that’s because BCMA really is only found on plasma cells, and those are the cells that go bad, if you will, for myeloma. And as myeloma progresses from its early stages onward, there’s more and more BCMA expressed. So that’s one reason BCMA is such a studied target in all sorts of drugs. But I think what we’re really excited about are kind of two BCMA areas. One is chimeric antigen receptor (CAR) T cell therapy, which I’m sure you’re very familiar with and probably all your listeners are. Right now, we’re anticipating that the Food and Drug Administration will probably approve ide-cell, that’s the bb2121 CAR T product for use in relapsed and refractory myeloma.
I think [BCMA] is going to be a game changer because it does offer patients who’ve had many lines of therapy a way to treat their myeloma. The progression-free survival, particularly in those patients who get a complete remission, is quite impressive. It is in some of those patients beyond a year, and that’s a great year for those patients by and large, because they’re not on other therapies. And we anticipate CAR T is going to be studied in earlier lines of therapy and may be moved on up.
And then of course, the second type of BCMA-targeted therapies that everybody is anticipating are the bispecific T cell engagers (BiTEs). Probably the one that may be furthest along is teclistamab, that is administered subcutaneously, and that looks very promising. There was some great data updated at [the American Society of Hematology (ASH) 2020 Annual Meeting], as well as [the American Society of Clinical Onoclogy (ASCO) Annual Meeting]. I think those drugs are going to be probably…certainly, I think we’ll see CAR T this year in 2021 and probably one BiTe, I think, by the end of the year.