Myeloma Expert Shares Highlights From ASH 2018

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Topics include: Treatment and Understanding

Patient Power founder Andrew Schorr is joined by multiple myeloma specialist Dr. James Berenson, from the Institute for Myeloma and Bone Cancer Research,to discuss exciting treatment and research developments announced at the 2018 American Society of Hematology (ASH) annual meeting in San Diego. Dr. Berenson discusses advances in strategy, testing and identifying new genetic targets in an ever-changing treatment paradigm. Tune in to hear the latest myeloma news.

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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.

Andrew Schorr:

Hello from the American Society of Hematology meeting in San Diego.  I'm Andrew Schorr with my friend and a myeloma specialist, Dr. James Berenson.  Let's see, Chief Scientific Officer and Medical Director at the Institute for Myeloma and…

Dr. Berenson:

…Bone Cancer Research.  

Andrew Schorr:

Hello from the American Society of Hematology meeting in San Diego.  I'm Andrew Schorr with my friend and a myeloma specialist, Dr. James Berenson.  Let's see, Chief Scientific Officer and Medical Director at the Institute for Myeloma and…

Dr. Berenson:

…Bone Cancer Research.  

 Andrew Schorr:

Oh, I always got to get it right.  Big title. Lots of work going on there. Dr. Berenson has been on the forefront of myeloma treatment for years.  Okay.   

Lots of discussion about myeloma here.  What impresses you?  

Dr. Berenson:

Well, I think what's impressive is we not only have new drugs we have new combinations of the already existing drugs, and they're moving up into the paradigm.  So a lot of these drugs which were just three or four years ago only at the very end line and only used as single agents are being given with three, four other drugs now and improving upon even those three drugs.  That's impressive.  

We're now doing cellular therapy of course with all the CAR?T cell news.  We're now looking at antibodies beyond the elotuzumabs, or Empliciti, and daratumumab, or Darzalex, into more targeted areas such as, of course, the BCMA target.  

Andrew Schorr:

Okay.  So there are monoclonal antibodies.  You've rattled off a couple, and there are others in development.  

Dr. Berenson:

Right.  

Andrew Schorr:

Right, with other targets.  

Dr. Berenson:

Yes.  

Andrew Schorr:

And added to, whether it was the RVD or other alphabet soup approaches that you've had. So somebody might get a four?drug combination.  

Dr. Berenson:

Yes, although, Andrew, I would tell you now in 2018 we may be able to discriminate who and who will not require more versus less therapy.  We have uncovered this new marker, BCMA, not only as a target but a monitoring device.  And we believe with its quick turnover you may be able to give patients less, not more, therapy and then make decisions within days instead of months about whether things are or are not working, meaning that you may be able to start with less, not more, and if you're not responding, we'll add another drug.  

Because truth be it, it really is only a few patients out of a hundred that are benefitting from the addition of these drugs.  It's not like a hundred patients benefit.  And if we can pre?identify those and, yeah, treat those but the other 90 percent, hey, you can get less treatment without the attended additional cost to the healthcare system, the side effects, etcetera, I think that's really important for the healthcare system.  

Andrew Schorr:

Okay. Let's talk about the healthcare system for a second.  In insurance and maybe with Medicare, there's this concern about step therapy where you have to fail different myeloma therapies before you might get what could be what you and science know might be right for them.  So there are these economic battles going on now too. 

Dr. Berenson:

Yeah.  My belief is if we can actually make decisions early with biomarkers, then we don't have to care about any of that, because the cost to the system is minimal to have somebody on therapy in a few days. We know with one week now with the dubiomarkers whether you're responding or not.  If you're not, get off.  Get on something else.  Or alternatively start with less.  So that certainly may change that paradigm.   

I would argue of course if you're on it for a number of months, it's costing the system $40? to $50,000 a month, in two months you may be up to nearly $100,000. But if it's one week it may be one?tenth of that, so you really have changed the playing field if you have abilities to actually pick and choose therapies dependent upon changes in these biomarkers within a few days.  

Andrew Schorr:

Now, MRD testing, whether it's measurable residual disease or minimal residual disease, is that what we're talking about here where somebody has one of these looking for one?in?a?million cells and are you down at that level, has your therapy worked?  

Dr. Berenson:

Well, I'm not a big proponent of that at this point.  I think it's a proof in concept.  I think it's able to be measured whether accurately or not especially with these flow?based assays, I'd argue that even with these other types of assays of course it's dependent upon sampling error in this heterogeneous bone marrow where you put a needle here and it's 1 percent, and there it's zero, and there it's 10, I'm not sure what all of that means.  The blood may be of fair determinance, and it kind of measures everything, but the problem in the blood is there's not so much tumor in the blood of myeloma, but there may be other ways to go.  

On the other hand, if you go from zero consistently up and you show that group is going to need therapy sooner, maybe you'll find it sooner.  Because the problem right now is M protein is really very slow to move, and you need a lot of it to be present.  Thus, all of these studies that show that MRD absence transplants to progression?free survival advantages, a duh moment for me because you can't measure the progression.  It's below the level of detection of the M protein, and they may be progressing for months, but you can't measure it.  

So every time you're below the detection level, you're not playing on the same level field. Whereas if you could measure everybody down here, you may not show that.  So. in fact, there are companies now developing M protein assays that will be a thousand?fold more sensitive, and they may actually give the answer without this complicated PCR?based assays requirement.  

Andrew Schorr:

Okay.  So what we could hope for with these companies and new development is more significant testing so that you get what's right for you and get what's working, and if something isn't recording you move on.  

Dr. Berenson:

Right.  So I think that that is not as important in the frontline where people pretty much all respond, although now I'm going to argue to you the opposite, that it may be in frontline we can tamp down therapies with some of these…

Andrew Schorr:

Do less.   

Dr. Berenson:

…with some of these biomarkers and say you don't need all that.  Because myeloma is not acute leukemia.  You know, you and I, 90 percent of myeloma patients, it's a slow?moving disease especially in frontline.  Now, there are the patients with renal failure, kidney problems, patients who have plasma cells in the blood, patients who have no blood counts because the marrow is so covered up, patients who have myeloma outside the marrow in the liver or spleen, they are bad actors, and nobody is going to take a risk in them.  You're going to treat them aggressively.  But that's a minority of the population.  

So I think most of it we may be able to begin to adjust therapy in ways that may be much more individualized.  Right now everybody gets the same thing.  It's one size fits all.  That's not what it should be.  

Andrew Schorr:

Okay.  So can we have subsets and can we do better with less as we know more about that patient.  

Dr. Berenson:

Yeah.  I think we need to do these studies, and I think the insurance companies may be a player here.  For the first time, they may engage in clinical research.  So we can do a study, say, randomizing a group to standard, lenalidomide, bortezomib and dex, and the other group, no, you're going to get two drugs and we're only going to add in the third if you have a rise in the marker or we predetermine based on markers, you're really needing three drugs versus two.  Those are things that will be important.  And also as you walk down the pathway of different therapies, just as important.  

Andrew Schorr:

Okay. Dr. Berenson, so some people come to you or an eminent specialist, a lot of people are treated in the community, and this is sounding complicated.  What would be some questions that you would urge people to ask or action to take so that they get what's right for them?  

Dr. Berenson:

Well, I think they need to ask, the first question of their prescribing doctor, believe it or not, can I get your cell phone.  Often that's not the case, but access to the doctor is key to good success, as I found out this morning in the many calls I've gotten.  I think you need to make sure that you can really talk to your doctor.  

I think you also have to be taken care of by a doctor who's willing to take advice from people who have seen a hundred times more.  They're not necessarily smarter than the local guys.  They could be just as smart as the myeloma guy.  It's all about seeing patients in the clinic.  So I believe that a lot of what are called KOLs or paper KOLs, they're not really hands?on KOLs, which is a whole different thing.  

Other things to find out from your doctor is how they deal with side effects, and also I would encourage them to find out how they're monitoring their disease.  Is it frequently enough, and are they changing things quickly enough, and how do they make those decisions.  Those are just general concepts.  

Andrew Schorr:

So the last thing I'd ask is are you hopeful for people because you have so much more to talk about, Jim, than you ever had before.  

Dr. Berenson:

Oh, yeah, it's unbelievable.  I go like this every day in clinic.  We recently had a four?drug combination with two pre-terminal people who I thought were going to be gone in a week and went into complete remission with drugs that aren't even approved for myeloma, one for CLL, Venclexta, with Velcade, Dara and dex, and it was tremendous.  It's not an on?label thing, but, hey, whatever works.  I'm not an on?label kind of guy anyway.  I need to treat the patient, not the NCCN guideline.  

Andrew Schorr:

Wow.  Thank you for all your dedication to folks with myeloma.  

Dr. Berenson:

All right. Thank you.  

Andrew Schorr:

Okay. Andrew Schorr with Dr. James Berenson from Los Angeles telling you that knowledge can be the best medicine of all. 

Oh, I always got to get it right.  Big title. Lots of work going on there. Dr. Berenson has been on the forefront of myeloma treatment for years.  Okay.   

Lots of discussion about myeloma here.  What impresses you?  

Dr. Berenson:

Well, I think what's impressive is we not only have new drugs we have new combinations of the already existing drugs, and they're moving up into the paradigm.  So a lot of these drugs which were just three or four years ago only at the very end line and only used as single agents are being given with three, four other drugs now and improving upon even those three drugs.  That's impressive.  

We're now doing cellular therapy of course with all the CAR?T cell news.  We're now looking at antibodies beyond the elotuzumabs, or Empliciti, and daratumumab, or Darzalex, into more targeted areas such as, of course, the BCMA target.  

Andrew Schorr:

Okay.  So there are monoclonal antibodies.  You've rattled off a couple, and there are others in development.  

Dr. Berenson:

Right.  

Andrew Schorr:

Right, with other targets.  

Dr. Berenson:

Yes.   

Andrew Schorr:

And added to, whether it was the RVD or other alphabet soup approaches that you've had. So somebody might get a four?drug combination.   

Dr. Berenson:

Yes, although, Andrew, I would tell you now in 2018 we may be able to discriminate who and who will not require more versus less therapy.  We have uncovered this new marker, BCMA, not only as a target but a monitoring device.  And we believe with its quick turnover you may be able to give patients less, not more, therapy and then make decisions within days instead of months about whether things are or are not working, meaning that you may be able to start with less, not more, and if you're not responding, we'll add another drug.  

Because truth be it, it really is only a few patients out of a hundred that are benefitting from the addition of these drugs.  It's not like a hundred patients benefit.  And if we can pre?identify those and, yeah, treat those but the other 90 percent, hey, you can get less treatment without the attended additional cost to the healthcare system, the side effects, etcetera, I think that's really important for the healthcare system.  

Andrew Schorr:

Okay. Let's talk about the healthcare system for a second.  In insurance and maybe with Medicare, there's this concern about step therapy where you have to fail different myeloma therapies before you might get what could be what you and science know might be right for them.  So there are these economic battles going on now too. 

Dr. Berenson:

Yeah.  My belief is if we can actually make decisions early with biomarkers, then we don't have to care about any of that, because the cost to the system is minimal to have somebody on therapy in a few days. We know with one week now with the dubiomarkers whether you're responding or not.  If you're not, get off.  Get on something else.  Or alternatively start with less.  So that certainly may change that paradigm.  

I would argue of course if you're on it for a number of months, it's costing the system $40? to $50,000 a month, in two months you may be up to nearly $100,000. But if it's one week it may be one?tenth of that, so you really have changed the playing field if you have abilities to actually pick and choose therapies dependent upon changes in these biomarkers within a few days.  

Andrew Schorr:

Now, MRD testing, whether it's measurable residual disease or minimal residual disease, is that what we're talking about here where somebody has one of these looking for one?in?a?million cells and are you down at that level, has your therapy worked?  

Dr. Berenson:

Well, I'm not a big proponent of that at this point.  I think it's a proof in concept.  I think it's able to be measured whether accurately or not especially with these flow?based assays, I'd argue that even with these other types of assays of course it's dependent upon sampling error in this heterogeneous bone marrow where you put a needle here and it's 1 percent, and there it's zero, and there it's 10, I'm not sure what all of that means.  The blood may be of fair determinance, and it kind of measures everything, but the problem in the blood is there's not so much tumor in the blood of myeloma, but there may be other ways to go.  

On the other hand, if you go from zero consistently up and you show that group is going to need therapy sooner, maybe you'll find it sooner.  Because the problem right now is M protein is really very slow to move, and you need a lot of it to be present.  Thus, all of these studies that show that MRD absence transplants to progression?free survival advantages, a duh moment for me because you can't measure the progression.  It's below the level of detection of the M protein, and they may be progressing for months, but you can't measure it.  

So every time you're below the detection level, you're not playing on the same level field. Whereas if you could measure everybody down here, you may not show that.  So. in fact, there are companies now developing M protein assays that will be a thousand?fold more sensitive, and they may actually give the answer without this complicated PCR?based assays requirement.  

Andrew Schorr:

Okay.  So what we could hope for with these companies and new development is more significant testing so that you get what's right for you and get what's working, and if something isn't recording you move on.   

Dr. Berenson:

Right.  So I think that that is not as important in the frontline where people pretty much all respond, although now I'm going to argue to you the opposite, that it may be in frontline we can tamp down therapies with some of these…

Andrew Schorr:

Do less.  

Dr. Berenson:

…with some of these biomarkers and say you don't need all that.  Because myeloma is not acute leukemia.  You know, you and I, 90 percent of myeloma patients, it's a slow?moving disease especially in frontline.  Now, there are the patients with renal failure, kidney problems, patients who have plasma cells in the blood, patients who have no blood counts because the marrow is so covered up, patients who have myeloma outside the marrow in the liver or spleen, they are bad actors, and nobody is going to take a risk in them.  You're going to treat them aggressively.  But that's a minority of the population.  

So I think most of it we may be able to begin to adjust therapy in ways that may be much more individualized.  Right now everybody gets the same thing.  It's one size fits all.  That's not what it should be.  

Andrew Schorr:

Okay.  So can we have subsets and can we do better with less as we know more about that patient.  

Dr. Berenson:

Yeah.  I think we need to do these studies, and I think the insurance companies may be a player here.  For the first time, they may engage in clinical research.  So we can do a study, say, randomizing a group to standard, lenalidomide, bortezomib and dex, and the other group, no, you're going to get two drugs and we're only going to add in the third if you have a rise in the marker or we predetermine based on markers, you're really needing three drugs versus two.  Those are things that will be important.  And also as you walk down the pathway of different therapies, just as important.  

Andrew Schorr:

Okay. Dr. Berenson, so some people come to you or an eminent specialist, a lot of people are treated in the community, and this is sounding complicated.  What would be some questions that you would urge people to ask or action to take so that they get what's right for them?  

Dr. Berenson:

Well, I think they need to ask, the first question of their prescribing doctor, believe it or not, can I get your cell phone.  Often that's not the case, but access to the doctor is key to good success, as I found out this morning in the many calls I've gotten.  I think you need to make sure that you can really talk to your doctor.  

I think you also have to be taken care of by a doctor who's willing to take advice from people who have seen a hundred times more.  They're not necessarily smarter than the local guys.  They could be just as smart as the myeloma guy.  It's all about seeing patients in the clinic.  So I believe that a lot of what are called KOLs or paper KOLs, they're not really hands?on KOLs, which is a whole different thing.  

Other things to find out from your doctor is how they deal with side effects, and also I would encourage them to find out how they're monitoring their disease.  Is it frequently enough, and are they changing things quickly enough, and how do they make those decisions.  Those are just general concepts.  

Andrew Schorr:

So the last thing I'd ask is are you hopeful for people because you have so much more to talk about, Jim, than you ever had before.  

Dr. Berenson:

Oh, yeah, it's unbelievable.  I go like this every day in clinic.  We recently had a four?drug combination with two pre-terminal people who I thought were going to be gone in a week and went into complete remission with drugs that aren't even approved for myeloma, one for CLL, Venclexta, with Velcade, Dara and dex, and it was tremendous.  It's not an on?label thing, but, hey, whatever works.  I'm not an on?label kind of guy anyway.  I need to treat the patient, not the NCCN guideline.   

Andrew Schorr:

Wow.  Thank you for all your dedication to folks with myeloma.   

Dr. Berenson:

All right. Thank you.  

Andrew Schorr:

Okay. Andrew Schorr with Dr. James Berenson from Los Angeles telling you that 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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Page last updated on January 21, 2019