Published on August 14, 2020
FDA Has Approved belantamab mafodotin for Treating Myeloma
Dr. Joshua Richter from Tisch Cancer institute at Mount Sinai Medical Center and Patient Power Co-Founder Andrew Schorr discuss the approval of Blenrep (belantamab mafodatin) a brand new drug and brand new target for multiple myeloma patients. Instead of just attacking a cancer cell, Blenrep works to deliver a toxic payload to the cancer cell so that the cell is not just attacked, but poisoned. Blenrep is associated with few side effects and is approved for use without dexamethasone, patients are excited to have a treatment with the option to treat without a concomitant steroid.
Transcript | Belantamab mafodotin (Blenrep) FDA approved for Multiple Myeloma
Hello, and welcome to Patient Power. I'm Andrew Schorr in California and joining us from New York City is a noted myeloma expert, Dr. Joshua Richter at the Tisch Cancer Institute at Mount Sinai Medical Center in New York City. And now we have a new approval for people with myeloma who have been refractory to many earlier treatments. They've had a lot of treatment and now there's a new drug that can possibly help them. Dr. Richter, please explain this for us.
Thank you, Andrew, for having me and thank you to the patients tuning in. So we're really excited to have this brand new drug bela-maf also called belantamab mafodotin. It's a brand new drug and a brand new target.
So many of our patients may be familiar with monoclonal antibodies, such as daratumumab (Darzalex), which targets CD38 and CD38 is on all the myeloma cells and this antibody targets it. What bela-maf is, is an antibody-drug conjugate. So first off it has a brand new target called BCMA, which stands for B-cell maturation antigen. This is a target that is also on all myeloma cells, but instead of just attacking any cell that has it, it actually delivers a toxic payload. This antibody-drug conjugate attaches to the cancer cell and injects a poison directly into the cancer cell that we call MMAF. So think about it like chemotherapy, but really not just going through the entire body, but when the antibody linker attaches to the cancer cell, it injects the chemo directly there.
So overall, it's a well-tolerated drug. It is associated with a few side effects, which may be new to some patients. Most notably something we call corneal side effects or keratopathy. The drug can affect vision. So if you are on the drug, we recommend regularly following up with an eye care specialist.
One thing that our patients may be happy about is the drug is approved without dexamethasone (Decadron). So steroids are the ultimate double-edged sword of myeloma. Some people love them. Some people hate them, but especially people who've gone through multiple rounds of therapy. It's nice to now have an option that can treat myeloma without the need for concomitant steroids.
The approval was based on studies, the DREAMM-1 and the DREAMM-2 studies. What did it show about effectiveness and durability of helping people?
Absolutely. So the DREAMM-1 and DREAMM-2 studies, and again, it's kind of kooky that all of the studies with this drug are called DREAMM. They're up to, I think DREAMM-9 by now. They show that in the early phase studies in DREAMM-1, bela-maf by itself had about a 60% response rate, but when they tested it in more patients in the DREAMM-2 study, it showed around a 30% response rate. Now, again, that's just the starting point. We know that with all drugs in myeloma there's a single-agent activity and refractory patients is around 30%. That's what we saw when carfilzomib (Kyprolis) was approved, daratumumab and selinexor (Xpovio).
What we're really excited about is some of the combination studies such as the DREAMM-6 study, which looks to combine bela-maf with drugs like bortezomib (Velcade) and dexamethasone. And there we see a marked improvement in the overall response rate and the durability.
Okay. So the bottom line is, yet another approval in myeloma to help people that many other therapies and give them hope and then continued research to see if this approved drug can work with other approved drugs to help even more people. Did I get it right?
Absolutely. Lots of hope for this new target, because every time we get a new class of drugs in myeloma, it's not simply one new therapy, it's many new therapies. So when we had Darzalex approved, we were able to then combine it with drugs like lenalidomide (Revlimid) and pomalidomide (Pomalyst). And for those people where that was inappropriate, we can combine them with drugs like Velcade. Same thing with a lot of our other therapies. And what we're excited about with bela-maf is its ability to combine with other drugs, such as the IMiDs, such as the proteasome inhibitors. So we're really using this to fine-tune our therapy for each individual about which medications may work best.
Some people who've been despondent where they've had multiple other therapies and they're no longer working. Now there's an improved drug that could give them some hope of a longer life.
Absolutely. And the real advantage of this is that we know BCMA is a prime target for a lot of different types of therapies. Currently under investigation or using BCMA as a target for antibody drug conjugates, like belantamab, a bifunctional antibodies and CAR T-cells. And the reality is not everyone is going to be eligible for a CAR T-cell, but here we can use bela-maf to use that type of target and technology, even in people for whom a CAR T is not appropriate or available.
Well, it's certainly good news. Thanks to the FDA for approving it in for kind of a fairly quick pace for approvals. Dr. Joshua Richter from Mount Sinai in New York. Thank you so much for being with us and explaining this approval of a new myeloma drug.
I'm Andrew Schorr with Patient Power. More hope for people with myeloma. Good news. Remember knowledge can be the best medicine of all.