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Bispecific Antibodies, Selinexor and Myeloma Clinical Trials

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Published on July 17, 2020

Latest Myeloma Treatment News: Bispecific Antibodies, Selinexor and Clinical Trials

Sometimes the FDA may put holds on clinical trials. How do these holds affect multiple myeloma patients?

In this segment from our recent Myeloma Answers Now program, host Andrew Schorr and myeloma experts Dr. Luciano Costa from the University of Alabama at Birmingham O’Neal Comprehensive Cancer Center and Dr. Joshua Richter of Tisch Cancer Instutite at Mount Sinai, discuss clinical trials for myeloma and managing the side effects of selinexor. Dr. Richter notes that, "clinical trials really ought to be moved a little further up...instead of being used when there are no other options". Watch to learn more.

This is the third of a four-part series. Click on the part to view the other parts in the series: Part 1, Part 2, Part 4.

This program is sponsored by Janssen Biotech, Inc. This organization has no editorial control. It is produced by Patient Power and Patient Power is solely responsible for the content.

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Transcript | Bispecific Antibodies, Selinexor and Myeloma Clinical Trials

Dr. Richter:
Probably the ones that are farthest along. There's a compound called AMG-701, I don't think it actually has a name yet if I'm not mistaken. I think we're probably about two years away - Dr. Costa, I don't know if you know any better, I think we're about two years away from that.

Dr. Costa:
I think that'll be my best estimate. I think they all, in those findings, there are at least three or four front runners, 701, there's 69… 32,69. And we all learn about the [inaudible] from Janssen. So they are finishing finding those and going to the cohort that we're going to find the efficacy.

Andrew Schorr:
Ladies and gentlemen, just remember, these guys are researchers, and they're rattling off names of trials. Please talk to your myeloma doctor about whether you're a candidate for a clinical trial. We've had a raft of new drugs over the last few years, Dr. Lonial talks about, and he counts it on both hands now. But here are these other new even classes of drugs. Could that be right for you? That's a discussion with myeloma specialists like these gentlemen who with us today.

Dr. Costa:
Yeah. So this is kind of the holy grail of CAR T-cell. Dr. Richter reminded us a few minutes ago, that the CAR T-cells are great, but between collecting cells and treating the patient, several weeks go by. The idea here is that you have a universal allogeneic donor CAR T that is generic, you can get from the shelf or from the freezer and give to the patient. So, that will be terrific. The patient doesn't have to wait, doesn't have to collect his own cells, it's not personalized. Now, the challenges are many. And this was a company that had a very early development of an off the shelf CAR T.

And I learned through the late press this week actually, that there was a death in one of those studies and that led to the FDA clinical hold. And that gets blown out of proportion, it's on the news all over. That doesn't mean necessarily the end of the program, it doesn’t necessarily mean it's the end of this approach. Unfortunately, these were patients who were very sick at times, and sometimes something bad happened and doesn't necessarily mean it was caused by the agent. It doesn't necessarily means it's something that cannot be overcome. So I think at this point it's very premature, but we can't help but be disappointed.

Andrew Schorr:
I want to make my own personal comment about clinical holds, because I'm very familiar with this, in cancers that I've been dealing with myself. In chronic lymphocytic leukemia, there's a drug that's approved now, called Venclexta or venetoclax. And yes, two patients died during the trial, as they realized it was a really powerful drug and they needed to have certain procedures to monitor the effect of it, so they reevaluated that. And now that drug is on the market and is part of the armamentarium for chronic lymphocytic leukemia. And maybe it'll be in myeloma someday, and some others.

Another drug, I take it, fedratinib or Inrebic, and there were patients that died and they realized, first of all, one of them was not because of the drug. So you were just mentioning that Dr. Costa, and the second was, is that there are certain things, a test they could measure and see, did you need supplements of vitamin B1, and could avoid any fatal issue? So this is what you're talking about, Dr. Costa. That's why you do clinical trials, right?

Dr. Costa:
Absolutely.

Andrew Schorr:
To develop a new drug, but to learn how to use it well.

Dr. Costa:
Absolutely. And if we need to be careful that the first few steps are very safe steps, so you don't kill that perspective completely. And you learn things that can be used throughout the remainder of the development of that agent.

Andrew Schorr:
Dr. Richter, we talked about whether there were upfront changes, and then we've referred also to people who are - nothing's working, then where does transplant fit in, CAR T, but also there are people who maybe are too frail for that, right? So I know there was the introduction of a drug called selinexor (Xpovio), where you have to learn how to work the side effects, nausea, and then new combinations. I think there was a BOSTON study. What do you have for people who are not right for transplant, not right for CAR T, but other things? They've gone through lots of lines of therapy. Dr. Richter?

Dr. Richter:
One of the things I would say has really encouraged participation in clinical trials, I think a lot of people have the idea, the notion that clinical trials are really only for when you have no other options. And people like Dr. Costa and myself who do this all the time, know that clinical trials really ought to be moved a little further up. And the main way to think about it is, there are many criteria to get on a clinical trial. And when you're earlier on in your disease, there's an easier likelihood of fitting those criteria. And then you still have all those standard of care options in your back pocket. It doesn't always work the other way around. So always consider entering into clinical trials. Selinexor is a good drug for people who have had a lot of other therapies. It's really all about the dose.

The drug seems to be tolerated a lot better when it's given once a week, as opposed to twice a week, and very aggressive pre-medications to avoid side effects. So using some of the out of the box medicines, like rolapitant (Varubi), and a couple of even antipsychotic drugs too, we give for nausea to prevent it, and we can actually get patients along the way with it. Panobinostat (Farydak) is a really good drug that people don't always think about so much. It's another pill, and it can be combined with drugs like bortezomib (Velcade) or lenalidomide (Revlimid). And it can actually re-sensitize people to that. So you may be on Revlimid and maybe not working anymore. You can add a drug like panobinostat to recapture. We have a new drug, isatuximab (Sarclisa), which is another monoclonal, so far only approved with pomalidomide (Pomalyst), but a study called the IKEMA study just read out as positive, so likely before the end of the year it'd be approved with carfilzomib (Kyprolis).

But yeah, I think the biggest message would be if you're not at a site that runs clinical trials with myeloma, and you can continue with your primary oncologist, at least once in your journey, visit a site like Dr. Costa's or my own, where these are options.

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