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FDA Approvals and Clinical Trials Increase Treatment Options for MCL Patients

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Published on December 20, 2019

Key Takeaways

  • Bortezomib (Velcade), ibrutinib (Imbruvica), acalabrutinib (Calquence) and lenalidomide (Revlimid) have been approved by the FDA for the treatment of MCL.
  • Maintenance therapy with rituximab is well-tolerated by MCL patients and can prolong survival.
  • CAR T-cell therapy is showing high response rates in clinical trials for the treatment of mantle cell lymphoma.

Between FDA approvals for targeted therapies and promising clinical trials with novel agents, the treatment landscape is changing rapidly for mantle cell lymphoma (MCL). During this interview, filmed at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, expert Dr. Joshua Brody discusses the latest MCL news, including which drugs are currently FDA approved, therapies in the pipeline and why patients can feel hopeful about the future. 

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Transcript | FDA Approvals and Clinical Trials Increase Treatment Options for MCL Patients

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Esther Schorr:

Hi there.  This is Esther Schorr at ASH 2019 in Orlando, Florida, and I'm here today with one of our favorite experts, Joshua Brody, Dr. Joshua Brody from Mount Sinai on the other coast from us.  

Dr. Brody:

Yes.  Yes.  There are two coasts in America.  We're pretty excited about this east one.  There's a lot of stuff going on.  We got pizza. 

Esther Schorr:

Pizza. 

Dr. Brody:

So excited about that.  It's great.  Yes.  On the East Coast in New York at Mount Sinai School of Medicine.  

Esther Schorr:

Yes.  Thank you for that. 

Dr. Brody:

Of course. 

Esther Schorr:

Dr. Brody, it would be really wonderful if you could help us do a little bit of education of the mantle cell lymphoma community.  I know that there is a lot going on in regards to that at ASH.  

Dr. Brody:

Thankfully. 

Esther Schorr:

And tell us what's happening. 

Dr. Brody:

Sure.  Sure.  A little bit of update but right, we should first state what we know.  Mantle cell lymphoma, it's a partly happy story in that mantle cell lymphoma historically was one of the worst non‑Hodgkin's lymphomas, generally incurable and historically we would say that people, patients with this disease would die in three or five years, and that's pretty bad compared to some of these other lymphomas. 

But that has improved tremendously with the advent of new therapies and FDA approvals for mantle cell lymphoma specifically.  So we have FDA approvals for we say bortezomib, called Velcade, for ibrutinib (Imbruvica), a BTK inhibitor and now acalabrutinib (Calquence), another BTK inhibitor, for Revlimid, and probably we'll have an FDA approval at sometime soon for venetoclax, a Bcl‑2 inhibitor.  So that's a lot of progress. 

Of course, we have kind of old standard therapies, the anti‑CD20 antibodies like rituximab (Rituxan), which work in mantle cell lymphoma well, not perfectly, but they work well.  But mantle cell lymphoma is even more sensitive to anti‑CD20 antibody immunotherapy than some of these other lymphomas.  For example, we talk a lot about maintenance rituximab therapy, giving the rituximab not just for the duration during chemo or four weeks but giving it for a couple years there afterwards.  And it's such a well-tolerated therapy that that's appealing because literally just about no side effects. 

And mantle cell lymphoma is the only one really where maintenance rituximab actually prolongs survival, and we've seen that in a few different studies now.  So we have a lot of good therapies that has improved survivals tremendously compared certainly 20 years ago, 15 years ago even.  Still a lot of room for improvement, so we have some of those improvements here at ASH 2019. 

Esther Schorr:

So I'm hearing by talking to some of the other experts here about combination therapies being used in other forms of lymphoma and leukemia. 

Dr. Brody:

Sure. 

Esther Schorr:

Is that true with mantle cell as well?  You're talking about all these different drugs.  

Dr. Brody:

Absolutely, combination is the most—sort of would say obvious combinations are CD20 antibodies plus chemotherapy CD20 antibodies plus some of these small molecule targeted therapies.  Absolutely.  Ultimately when people talk about combinations of some of these targeted therapies like BTK inhibitors, like ibrutinib or acalabrutinib plus Bcl‑2 inhibitors like venetoclax, and we've seen that those actually are a potent combination.  Maybe they have a greater than additive benefit, but not any of them standard therapies yet so far for those combination targeted therapies.  That may be coming down the road. 

Esther Schorr:

Okay.  So what else?  You mentioned that there were some other things that you wanted to share with this community that are going on as well.  

Dr. Brody:

You know, we're very lucky in mantle cell lymphoma that we can learn from some of the other B‑cell non‑Hodgkin's lymphomas and just like we have CA- T cells attacking this molecule CD19 in diffuse large B‑cell lymphoma, even in acute leukemias and some other spaces as well, some other types of lymphoma.  We have data here at this ASH about the first 60 patients treated with mantle cell lymphoma with CAR T‑cells.  

These are CAR T similar to what we call Yescarta or axi‑cel (axicabtagene ciloleucel) from a company Kite Gilead, and that data here, one of the first trial of six Zuma trials, shows incredibly high response rates in patients with mantle cell lymphoma that the lymphoma has found ways to trick, you know, every type of chemotherapy and small molecule inhibitors and still very high response rates to this CAR T‑cell therapy.  And it seems like those‑‑those remissions last for a long time—so very promising I think. 

Esther Schorr:

So for patients who have been diagnosed with mantle cell, what should be the takeaway from all of this as far as they get the diagnosis and then what?  What should they be asking about as far as testing and exploring these possibilities of treatment?  

Dr. Brody:

Let me say this:  There are many types of lymphoma and CLL where the therapy you might get in an academic center and with your community oncologist may be the exact same therapy, and truthfully in some of those cases, maybe with some of these low‑risk CLL patients there's no real benefit to seeing the academic center, because you'll get the same therapy.  Maybe you can meet a second opinion one time at the academic center. 

In mantle cell lymphoma that is not the case.  This is still such a serious cancer with so many rapid changes in the front‑line therapy but also rare enough that the community oncologists don't get to see much mantle cell lymphoma.  Every single one of these patients should be seen at least in the beginning by a lymphoma expert at an academic center.  They may be able to then continue their therapy at the local community oncologist, and that might be more convenient, but they absolutely need to be seen in an academic center, both to find out what are the latest updates, the best therapy, the safest therapies, but also what is the new most exciting stuff coming down the pike, because they may need to take advantage of these new therapies. 

Esther Schorr:

And so then there can be an easy connection, I would think, between that academic center specialist and a local practitioner. 

Dr. Brody:

Absolutely.  I mean, our favorite thing is if the therapy is a simple straightforward therapy why do they have to come and see us if it's a two‑hour drive?  Just get this therapy but come back and see me in six months and be seen by a local community oncologist in the meanwhile.  But they need to be hooked in with the academic center so we can see how it's going six months later and see if we need to make a change or not. 

Esther Schorr:

Right.  Well, this sounds very hopeful for what was a very, very serious—serious form of lymphoma. 

Dr. Brody:

We're very grateful for this progress.  I mean, it makes a real difference in people's lives, so we're extremely grateful for it. 

Esther Schorr:

Well, we're very grateful to have you working on these very big problems. 

Dr. Brody:

I appreciate it, Esther.  Thank you. 

Esther Schorr:

Thank you so much for being here.  

And this is Esther Schorr and our favorite, Dr. Brody, from ASH in Orlando.  Remember, knowledge can be the best medicine of all. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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