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Published on December 18, 2020
What Does the FDA Approval of Blenrep Mean for Multiple Myeloma Treatment?
Blenrep, a monoclonal antibody, was approved by the FDA in August 2020 for use in multiple myeloma treatment. Ongoing studies are showing promising results for Blenrep in combination with other drugs. This includes the DREAMM studies: clinical trials offering exciting new treatment options for multiple myeloma patients.
Listen in as Dr. Robert Rifkin, MD, Hematologist/Oncologist at Rocky Mountain Cancer Institute, joins Patient Power co-founder Andrew Schorr to discuss the results of clinical trials using Blenrep. This includes the benefits and side effects that patients are experiencing, why clinical trials are so important for improved treatments, and why multiple myeloma patients should pay attention to this new drug, as reported at ASH 2020.
This program is sponsored by GlaxoSmithKline. This organization has no editorial control. It is produced by Patient Power, and Patient Power is solely responsible for program content.
Transcript | Blenrep and New Clinical Trials for Multiple Myeloma
Andrew Schorr: Hello, and welcome to Patient Power. I'm Andrew Schorr in Southern California. Joining us from near Denver, is Dr. Robert Rifkin, who is a noted myeloma specialist, a hematologist, oncologist at Rocky Mountain Cancer Centers, and also a leader within US Oncology for myeloma across the country. Dr. Rifkin, welcome to Patient Power.
Dr. Rifkin: Thank you, Andrew.
Andrew Schorr: Dr. Rifkin, I want to talk to you about a study you've presented at this year's virtual ASH Meeting, the data so far in the DREAMM-7 study, it's studying a new monoclonal antibody. What does this mean? What are we finding out so far?
What Can You Tell Us About New Clinical Trials for Multiple Myeloma?
Dr. Rifkin: Well, the DREAMM program is actually a much larger program to investigate a drug that we'll just call belamaf (belantamab mafodotin-blmf) because the name is way too long to pronounce, but this is a novel drug, that's a monoclonal antibody drug conjugate. So, it's very exciting in that regard because in myeloma, as you know, over the last two or three years, even there's been an explosion in the number of new agents available to treat patients.
Oftentimes we start with a triplet therapy, almost no matter whether you're transplant eligible or ineligible, and more often than not, obtain a significant response. And then perhaps you might get placed on a maintenance therapy, but as all of you and your readers know, myeloma remains an incurable illness. And the real question is what do you do now when somebody relapses, especially if they've seen proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies?
And the exciting part about this molecule, is that it's a completely different class of drugs than we've used with any great regularity in multiple myeloma. And the data we're presenting at this year's ASH really is an exciting trials in progress. As you know, the DREAMM program really has around 19 studies, the earlier ones, DREAMM-1 and -2 are largely complete and the data from those was used to advance dose and schedule going forward.
So, in DREAMM-7, we're very excited to treat patients that have suffered the inevitable relapse, if you will. And we're going to use the new molecule, which we'll call Blenrep in combination with dexamethasone (Decadron), and study that against a monoclonal antibody, daratumumab (Darzalex) in combination with dexamethasone. This is a trial that's relatively new and will accrue over 400 patients worldwide, accrual is ongoing now. Perhaps the most interesting thing is, not only its novel mechanism of action, but there is a sort of a unique toxicity which may slow down the development of the drug, but is actually very manageable once you learn about it.
This is a very unusual toxicity. It's a corneal toxicity, but it's not like the usual things that we used to see with high dose cytarabine (Cytosar-U) and other things. And it does require a bit different management and probably appropriately garnered a black box warning in a REMS (Risk Evaluation and Mitigation Strategy) program, because the key to realizing the true benefit of this exceptional drug, is to be thoroughly educated regarding the ocular toxicity and the manufacturer has done an excellent job for this.
Andrew Schorr: Dr. Rifkin, there's no free lunch if you will, when it comes to cancer medicines. These are powerful medicines and there's frequently some sort of side effect that hopefully can be managed. When you mentioned ocular toxicity related to this new drug Blenrep or belamaf in studying it, how big a deal is this versus its power in fighting the cancer?
What Are the Side Effects of Blenrep?
Dr. Rifkin: So, if you look at the example of daratumumab, a monoclonal antibody, we found out interestingly, that patients began to sneeze during the infusion, and everybody pretty much blew that off initially. But when you look at the biology, the target for daratumumab which is an anti-CD38 in myeloma, is also expressed in the upper respiratory tract epithelium. So, once we learned how to treat that with Singulair and other blocking agents, that becomes much less of an issue.
Similarly, in this case, the ocular side effect is best characterized as an off-target effect. And the key is early recognition, just like anything else, adjusting the dose and doing the appropriate supportive care things, ophthalmologists are very good at looking at this with slit lamps, photographing corneas. And the important thing to remember is in the vast majority of cases, it resolves and it's very treatable. Sometimes we have to dose interrupt or dose reduce, but I think it's a relatively small price to pay for this very specific and powerful new agent.
Andrew Schorr: And my understanding is what the target is, is something called BCMA, am I right? and that's a target on myeloma cells?
What Is BCMA?
Dr. Rifkin: Your questions are perfect, they're setting me up. But anyway, BCMA is one of the hottest targets in myeloma research now, and at this year's ASH, you'll hear all kinds of BCMA targeted presentations, perhaps the one receiving the most attention is a CAR T-cell that has a BCMA target, and that's moving along nicely. It's available under certain circumstances for patients with multiple myeloma. In addition, BCMA is a fruitful target for a variety of other things, including just a simple anti monoclonal BCMA molecule and then you can imagine you can do, lots of other things.
So, there'll be bi-specific T-cell engagers where BCMA is one of the targets and all kinds of other novel combinations. BCMA is very common in myeloma patients and is present in about 95% plus of all of the myeloma cells. And there are not many off targets for this, so it's very specific for myeloma and that's actually... One of the most exciting things is to see what we can do with a newly discovered molecular target, whether it's CAR T-cells, monoclonal antibodies, drug antibody conjugates, bi-specific T-cell engagers and then you can imagine lots of other things that would use the BCMA as a target.
Andrew Schorr: Okay. So just to tie this all together for our patients, if someone has relapsed, there are monoclonal antibodies that can be used and now you have a new one with ongoing study in the series of DREAMM studies and you feel it's a positive advance. There could be some ocular toxicities, as you say, that can be monitored, but also can be controlled, so that the benefit of the medicine stands out.
Dr. Rifkin: That's a very good summary. And as you and your audience know, this drug has recently been approved based on a prior DREAMM study. And so it's out there, it's getting integrated into all of the clinical pathways, although as you know, that takes some time to get into pathways and guidelines, but it will definitely have a very valuable place in our armamentarium to treat patients with multiple myeloma.
Andrew Schorr: Okay. Dr. Robert Rifkin, thank you for helping lead, research all across the country related to multiple myeloma and your dedication to patients in Colorado. Thanks so much for being with us.
Dr. Rifkin: Thank you very much, Andrew.
Andrew Schorr: I'm Andrew Schorr, remember knowledge can be the best medicine of all.
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