00:00:00:00 - 00:00:08:04

00:00:08:20 - 00:00:09:22
 
What is ELREXFIO?

00:00:11:07 - 00:00:14:18
 
So this is a very unique type of immunotherapy.

00:00:14:18 - 00:00:24:05
 
So, ELREXFIO, or in the medical terminology, elranatamab. So the MAB stands for monoclonal antibody

00:00:24:05 - 00:00:29:04
 
is a bispecific antibody. So think about this Bispecific antibody having

00:00:29:04 - 00:00:48:04
 
two arms with one arm. It is hooking the myeloma cell with the other arm. It is hooking the T cell. T cells are the ones that kill the myeloma cells. So bringing both of them together in proximity so that you’re allowing for the T cell directed myeloma cell cell kill

00:00:48:04 - 00:00:57:08
 
previous approval for a for a similar kind of for bispecific antibodies for teclistamab and myeloma. So there's a second

00:00:57:08 - 00:01:05:03
 
BISPECIFIC antibody targeting the BCMA as well as the CD3 on the T cells.

00:01:05:02 - 00:01:09:10
 
So one can ask why BCMA? So what is BCMA

00:01:09:09 - 00:01:18:07
 
so B cell maturation antigen is a is a protein that is present on the myeloma cells that could be used as a target.

00:01:18:07 - 00:01:22:11
 
An ideal target is something that has to be specifically present on a target.

00:01:22:12 - 00:01:41:08
 
cell. So here for us the targets cell is a myeloma cell and you have you should have minimal expression on the surrounding tissues. So the target antigen should have minimal expression on the normal tissue so that you minimize the off target side effects.

00:01:41:08 - 00:01:54:02
 
So you only want the on target site on target side effect which is the drug has to go bind to the myeloma cell and allow for the cell kill to happen with the T cells.

00:01:54:04 - 00:01:57:22
 
So now in here, where is BCMA seen BCMA

00:01:57:22 - 00:02:13:18
 
is seen on mature B cells and it is also seen in some normal cells like the RBCs, like some of the hematological cells are only the progenitor cells that we can see,

00:02:13:18 - 00:02:18:09
 
but not in the non-hematological cells So that makes it the beauty of this drug.

00:02:18:15 - 00:02:22:18
 
Why we went went all after this specific target is

00:02:22:18 - 00:02:30:21
 
the minimal expression on the other tissues and the maximal expression on the target target cell that we have.

00:02:31:12 - 00:02:35:07
 
What is the current indication for ELREXFIO? Who is ELREXFIO approved for?

00:02:37:11 - 00:03:02:19
 
So let me start with talking about what is ELREXFIO approved for today. And so ELREXFIO or elranatamab is approved for multiple myeloma patients who had received four prior lines of therapy, including an IMiD, a PI, CD38 monoclonal antibody and making all together four

00:03:02:19 - 00:03:08:06
 
different lines of therapy. So let me break it down by what is a line of therapy.

00:03:08:08 - 00:03:13:14
 
So in simple terms, one can ask the question, How many times have you progressed?

00:03:13:14 - 00:03:22:07
 
And and in each progression there is a change in the therapy. So that is a simplest or The dirty way of calculating how many lines of therapy people have.

00:03:22:07 - 00:03:32:05
 
For example, somebody has an induction therapy with RVD, somebody has a transplant, then has maintenance that all counts as one line of therapy.

00:03:32:07 - 00:03:56:08
 
So it is not uncommon that we have this discussion with clinics every day. So why are these not considered three different lines of therapy? Because you have not progressed three different times. You have not progressed at all. So once patients are progressing on the REVLIMID maintenance, so that is considered as one line of therapy which on the next line is started is a second line of therapy.

00:03:56:09 - 00:04:04:13
 
So every time there is a progression, there's a change in the treatment and that change in the treatment counts for one line of therapy.

00:04:04:13 - 00:04:10:19
 
So I hope it made it a little simpler for people to understand. So in those lines of therapy,

00:04:10:19 - 00:04:31:08
 
you need to use an IMiD, which is the pomalyst, or revlimid, or Thalomid, you have to use a PI, which is ixasomib bortezomib, or carfilzomib. and a CD38 monoclonal antibody, which is we only have two of them approved so far, which are daratumumab or isatuximab

00:04:31:08 - 00:04:38:18
 
there to see those lines of therapy, to fit those lines of therapy, or to see those exposures to these drugs before you get qualified

00:04:38:21 - 00:04:40:20
 
for elranatamab.

00:04:41:10 - 00:04:45:11
 
What was the name of the trial that led to accelerated approval and what were the main findings?

00:04:46:23 - 00:04:57:14
 
with the prior approval of teclistamab, we saw a response rate of 60 to 63% for these patients who are heavily refractory who had seen 6 prior lines of therapy

00:04:57:14 - 00:05:09:01
 
here with elranatamab, patients are much more refractory with seven prior lines of therapy and these patients had a response rate of close to 60%.

00:05:09:03 - 00:05:18:13
 
So two in three people responded to the drug. And these are good responses and heavily refractory patient population.

00:05:18:13 - 00:05:23:11
 
magnetism, three is the trial that showed the response rates that we talked about.

00:05:23:11 - 00:05:32:00
 
It's 60% and these are deep responses. Most of the patients, 90% of the patients that had a response have greater than vgpr

00:05:32:01 - 00:05:41:00
 
based on the initial response rate of 60%, they’re approving this drug based on an accelerated approval.

00:05:41:02 - 00:05:48:06
 
Nevertheless, there is a caveat that you need to prove to us that this drug is active against the standard of care

00:05:48:06 - 00:05:54:04
 
that is an ongoing complementary trial to make this accelerated approval, real approval and full approval.

00:05:54:06 - 00:06:03:09
 
And those trials are ongoing cooking at this time. And we hope to anticipate to get those results possibly within the next two years or so

00:06:03:22 - 00:06:06:12
 
How is ELREXFIO administered and what is the dosage?

00:06:07:08 - 00:06:11:00
 
it's a subcutaneous administration. It is given on the belly

00:06:11:00 - 00:06:17:10
 
when you talk about ELREXFIO, it is given in three different doses. So it's called a priming dose.

00:06:17:10 - 00:06:32:14
 
there's a dose 12 milligram as a flat dose that is given first, the second priming dose is given 48 hours later, and that is given at 72 milligrams and the third dose is given another 48 hours after as that.

00:06:32:16 - 00:06:52:20
 
That is the third dose or the target dose. So think about this, priming dose, priming dose, target dose. So each of them are separated by 48 hours. So 12 mg, 32 mg, 76 mg and these are all flat doses. So now if you look at the REMS program,

00:06:52:20 - 00:06:58:01
 
what is REMS program, it's called the risk Evaluation and Mitigation strategy.

00:06:58:03 - 00:07:06:02
 
So this is a program that helps with certain drugs that have a higher risk to minimize the risks. And the recommendation

00:07:06:02 - 00:07:09:08
 
for the REMS program is to hospitalize patients

00:07:09:08 - 00:07:20:20
 
for receiving elranatamab for 48 hours after the first dose, 24 hours after the second dose, and the patient could be discharged because the risks of cytokine syndrome are so predictable.

00:07:20:20 - 00:07:23:06
 
They happened very, very early in the course.

00:07:23:06 - 00:07:28:05
 
So that is how it is designed and that is what the package insert looks like.

00:07:28:21 - 00:07:34:08
 
After you receive your first full treatment dose. ELREXFIO is usually given one time each week through week 24.

00:07:34:23 - 00:07:44:20
 
Starting on week 25, your future doses will usually be given one time every two weeks for patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a partial response or better and

00:07:44:20 - 00:07:46:23
 
maintained this response for at least two months.

00:07:47:12 - 00:07:55:12
 
ELREXFIO is a fixed dose with no weight based calculations. Patients should continue treatment with ELREXFIO until disease progression or unacceptable toxicity.

00:07:56:08 - 00:07:59:04
 
Can biweekly dosing start sooner than week 25?

00:07:59:22 - 00:08:15:05
 
So here what I want to clearly say is once we achieve a good response, there's always the decision between the patient and the physician to say, Hey, is this the time where I could say we got the response, Now we want to maintain the response.

00:08:15:07 - 00:08:41:23
 
Can we ease off on the pressure that we're putting on the immune system and try to let them let the function to recover? So rather than constantly bombarding these T cells and we we have seen the data that by going to every other week at a later time, after the 26 weeks or so, say after the first six months to go to every other week, that is how the trial has been designed.

00:08:42:01 - 00:09:00:20
 
But if you achieve a complete response and a great response more than VGPR in the first two months, I would challenge why you should not go to every other week at this point. So I'd be ending up in trouble because I'm questioning the dogma. But but that's what I want. What I'd really love

00:09:00:20 - 00:09:07:15
 
to do for my patients to see when is the right time for us to see when we can peel off the drugs that they don't need.

00:09:07:17 - 00:09:15:06
 
So we need to come off the mindset that more is good. So minimal effective dosing is how we want to go.

00:09:15:21 - 00:09:26:06
 
Please note that the prescribing instructions state that patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a partial response or better and maintained this response for at least two months can switch to

00:09:26:06 - 00:09:27:08
 
biweekly dosing.

00:09:28:09 - 00:09:31:01
 
If you are considering switching to biweekly dosing sooner,

00:09:31:01 - 00:09:33:15
 
this is a decision you must make with your treating physician.

00:09:34:14 - 00:09:38:04
 
Are any prophylactic medications given before an ELREXFIO injection?

00:09:39:09 - 00:09:52:13
 
what we typically do is go as a pre medications using some Benadryl, using some Tylenol for every patient that receives with every dose. So that's what we typically do is pretty medications for everyone.

00:09:52:14 - 00:09:55:13
 
In our practice, we give it every single time.

00:09:56:04 - 00:10:06:11
 
According to the prescribing instructions, pre medications should be administered one hour before the ELREXFIO injection for both step up doses days one and four as well as for the first treatment dose day 8

00:10:07:12 - 00:10:15:15
 
Pre-medications include acetaminophen or Tylenol or the equivalent dexamethasone or the equivalent diphenhydramine or Benadryl or the equivalent

00:10:16:14 - 00:10:19:03
 
What are the biggest risks associated with ELREXFIO?

00:10:20:13 - 00:10:25:09
 
the biggest risk for giving elranatamab like drugs is mostly

00:10:25:10 - 00:10:28:06
 
the CRS And the neurotoxicity that you're worried about.

00:10:28:19 - 00:10:30:11
 
What is cytokine release syndrome?

00:10:30:16 - 00:10:33:19
 
When is CRS most likely to occur and how is it managed?

00:10:34:15 - 00:10:39:03
 
So the cytokines are released from the body when there is an active

00:10:39:02 - 00:10:46:15
 
myeloma cell killed. This is a immune stimulation that is happening where the body's responding by releasing the cytokines.

00:10:47:06 - 00:10:51:17
 
CRS is common during treatment with ELREXFIO and can also be serious life threatening

00:10:51:17 - 00:10:52:17
 
Or can lead to death.

00:10:53:09 - 00:10:59:02
 
Tell your health care provider or get medical help right away if you develop any signs or symptoms of CRS including.

00:10:59:02 - 00:11:04:14
 
A fever of 100.4 degrees Fahrenheit, 38 degrees Celsius or higher. Trouble breathing,

00:11:04:16 - 00:11:05:03
 
chills,

00:11:05:07 - 00:11:06:16
 
dizziness or lightheadedness.

00:11:06:20 - 00:11:07:19
 
Fast heartbeat

00:11:07:19 - 00:11:08:15
 
Or a headache.

00:11:09:04 - 00:11:18:20
 
CRS happens very frequently. Almost two thirds of the patients have this, and very rarely less than 1% of patients where it's in grade three.

00:11:18:22 - 00:11:20:15
 
So how do we

00:11:20:15 - 00:11:39:06
 
grade them first? So grade one is the time where somebody has a minor fever. They have a grade one. Grade two is the one that is a sustained fever, that there are simple metrics of oxygenation. And everything that we look at to grade them into grade 2. So the higher the grade, it is, the bad it is.

00:11:39:08 - 00:11:59:07
 
So we don't want higher grade toxicities to happen. So if somebody is seeing a grade one or grade two, we always want to mitigate it by giving a prophylactic treatment. So this is all about the CRS. So now let's talk about when this happens.

00:11:59:07 - 00:12:06:09
 
So all of what we see in terms of the CRS is happening right in between the first and second dose.

00:12:06:13 - 00:12:12:08
 
And earlier as close to the second dose as possible. That is why the REMS program has been designed that way.

00:12:12:08 - 00:12:29:22
 
Can we do something more prophylactically to prevent the CRS? So we have gone in the past with what is called ASTCT guidelines ASTCT. The guidelines say if somebody has a greater than grade two CRS, they're the ones that would need the tocilizumab.

00:12:30:00 - 00:12:49:03
 
And we learned very quickly that we don't need to wait for somebody to go from grade one to they do everything has to start at a grade one. It doesn't started a grade two. If you're seeing those early signs of those grade one CRS, we could just start and act the antidote which is the Tocilizumab that is given again as a shot.

00:12:49:03 - 00:12:56:14
 
It can be given three times every 8 hours apart, but most patients that receive the bispecific antibodies will need only one shot.

00:12:56:15 - 00:13:13:01
 
despite what we're talking about, giving this prophylaxis with the Tosi treatment, with the Tosi, everybody, everybody, everyone gets a tylenol and Benadryl prior to each of these doses as the real prophylaxis, just like how we do for any blood transfusions.

00:13:14:00 - 00:13:24:15
 
In addition to CRS neurologic toxicity occurred in 59% of patients. Most neurological toxicities were grade one and two. Grade three or four toxicity occurred in 7% of patients.

00:13:25:13 - 00:13:27:10
 
Neurologic toxicities included.

00:13:27:13 - 00:13:28:21
 
Headache 18%.

00:13:29:03 - 00:13:31:14
 
Changes in mental function 15%.

00:13:31:20 - 00:13:33:16
 
Motor dysfunction 13%.

00:13:33:23 - 00:13:36:04
 
Sensory neuropathy 13%.

00:13:36:10 - 00:13:36:15
 
And

00:13:37:03 - 00:13:37:20
 
Guillain-Barre syndrome

00:13:37:20 - 00:13:39:01
 
Point 5%.

00:13:39:23 - 00:13:45:21
 
In the clinical trial, ICANS occurred in 3.3% of patients who received ELREXFIO at the recommended dose.

00:13:45:21 - 00:13:48:09
 
Most patients have ICANS after the first step up dose.

00:13:48:12 - 00:13:54:00
 
One patient had ICANS after the second step up dose and one patient had ICANS after subsequent doses.

00:13:54:09 - 00:13:57:11
 
Recurrent ICANS occurred in 1.1% of patients.

00:13:58:23 - 00:14:00:00
 
What is ICANS?

00:14:01:23 - 00:14:08:15
 
So ICANS is a very unique concept meant for this, meant for the T-cell directed therapies. It's called

00:14:08:15 - 00:14:11:20
 
immune cells affected neurotoxicities syndrome.

00:14:11:19 - 00:14:14:08
 
we still fully don't understand the exact

00:14:14:08 - 00:14:17:06
 
mechanism of why ICANS happens,

00:14:17:06 - 00:14:22:11
 
and it is seen in less of patients than what we see in this series.

00:14:22:11 - 00:14:34:14
 
So if you look at all grade neurotoxicity count like as a headache, as somebody that has that woke up, you're waking up the patients at 3 a.m. and asking them to do these many mental studies exam,

00:14:34:14 - 00:14:36:02
 
those numbers can be high.

00:14:36:04 - 00:14:59:14
 
But I don't want you to be scared about that. The real problems that I always think about are the grade three or higher toxicities where patients can present with seizures. Patients can have that they don't know where they are, that a temporary phase where they're not in the room. So those are the higher grade neurotoxicities. those can be seen in less than 2 to 3% of patients.

00:14:59:18 - 00:15:04:18
 
It's a very, very small number. But these are always reversible, as we can see.

00:15:04:18 - 00:15:10:18
 
And fortunately with elranatamab that, we see the risk is almost negligible.

00:15:11:07 - 00:15:14:23
 
The median time to onset of ICANS was three days after the most recent dose

00:15:14:23 - 00:15:16:20
 
with a median duration of two days.

00:15:17:15 - 00:15:26:05
 
The most frequent clinical manifestations of ICANS included a depressed level of consciousness in grade one or grade two immune effect your cell associated encephalopathy scores.

00:15:27:05 - 00:15:33:10
 
The onset of ICANS can be concurrent with CRS following resolution of CRS or in the absence of CRS.

00:15:34:01 - 00:15:44:17
 
Patients are advised not to drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the two step up doses and the first treatment dose within the ELREXFIO step up dosing schedule

00:15:44:17 - 00:15:45:19
 
And in the event of new.

00:15:45:19 - 00:15:49:05
 
onset of any neurologic toxicity symptoms until symptoms resolve.

00:15:50:05 - 00:15:51:23
 
What is hypogammaglobulinemia?

00:15:53:05 - 00:16:22:21
 
as we talked about how these drugs work, the the plasma cells are the are the ones that make the immunoglobulins. So here we're going against a war against the plasma cells. So not just the myeloma cells, all plasma cells. So which means the normal immunoglobulins that your normal plasma cells make are all invaded by, by the T cells that are being redirected by these bispecific antibodies.

00:16:22:23 - 00:16:39:08
 
So which means in essence, what we expect there is not as many plasma cells making as many antibodies. So the quantitative levels of these immunoglobulins drop and drop and drop as we see with the continuous administration of these drugs. So

00:16:39:09 - 00:16:48:17
 
do we have to rely on the on the plasma cells to make the antibodies? Absolutely, yes. And at the same time, this is one of the mechanisms I was talking about,

00:16:48:18 - 00:16:58:15
 
why it is so imperative for us, once you achieve a response, you need to peel off these drugs, extend the interval so that the plasma cells have a breathing space so that they would be able to make those antibodies.

00:16:58:17 - 00:17:08:11
 
But until the time you are at a higher risk for infections with low immunoglobulins, and that is the place where we have historically used

00:17:08:12 - 00:17:16:04
 
artificial immunoglobulins to supply to replace the immunoglobulins that that are not being made by the body.

00:17:16:20 - 00:17:24:19
 
Artificial intravenous immunoglobulin or IVIG is a pooled antibody and a biological agent used to manage various immunodeficiency states.

00:17:25:07 - 00:17:31:00
 
IVIG can be very effective at preventing or treating infections in persons who do not have antibodies or who have low levels

00:17:31:00 - 00:17:31:22
 
of antibodies.

00:17:32:13 - 00:17:42:01
 
IVIG is prepared from the blood donated by thousands of people to make a super concentrated and very diverse collection of antibodies against many possible infectious organisms. Your body might encounter.

00:17:42:16 - 00:17:46:09
 
The ultimate goal of this therapy is to normalize a compromised immune system.

00:17:47:08 - 00:17:49:07
 
How can infection risk be minimized?

00:17:50:08 - 00:18:02:23
 
When it comes to infections, we always are very, very cautious. So the first thing that I say, this is a time of the year when we all get the vaccinations so people get the flu shot, people get their RSV shot.

00:18:02:22 - 00:18:04:17
 
people have the COVID boosters.

00:18:04:21 - 00:18:31:06
 
So all of those tell us that the best thing that you can do, how can you do something to help yourself? Number one, increase your layers of protection, increasing your layers of security to prevent any of these infections. Number one, get all these vaccines. Number two, get the IVIG artificial immunoglobulins that your body is not able to produce because we've been knocking off all these B cells.

00:18:31:08 - 00:18:54:20
 
Number three, So taking some antivirals, if there's a risk of any special viral reactivation, we want to give those viral suppressors so that you suppress the reactivations? So these are all of what we say. Should I get this or should I not get. This is not the question that you want to ask. We want what we want to ask is what is what is the best chance that I have to minimize all these complications is how I'd be looking at it.

00:18:55:01 - 00:19:13:15
 
So if I'm able to do all these with what we talked about, so the risk of infection minimizes drastically. That still doesn't say that infection risk is zero, infection risk still stays higher. So still, you need to follow all your precautions that you normally do.

00:19:14:04 - 00:19:17:21
 
What prophylactic medications would you recommend while taking ELREXFIO?

00:19:19:02 - 00:19:24:23
 
Acyclovir is something that I would leave on all my patients, that would receive any myeloma therapy.

00:19:24:22 - 00:19:41:10
 
the reason is herpes-zoster or shingles virus is something that's already in all of all of our bodies. So it's a matter of time when there is a immune suppression, the virus pops up. So it's not about having it all at one time.

00:19:41:12 - 00:19:53:22
 
It leaves those the it lives that residual pain forever. If somebody had shingles once, they can tell you how bad it is and where they have the shingles for the rest of the life.

00:19:54:00 - 00:20:23:03
 
So everybody gets acyclovir in my practice. or valcyclovir, So the second one you talked about, bactrim a great point, bactrim also has some side effects. So bactrim’s side effects are cytopenias. And what we in terms of in trying to help the patient, we don't want to harm. So that's why I peel away on the bactrim I don't use it as much, but in somebody that becomes lymphopenic that becomes low lymphopenia low lymphocyte counts.

00:20:23:08 - 00:20:36:22
 
And those are the patients that I introduce Bactrim at the later time so that the patients do not acquire this immunosuppressive pneumonia that you see in the immunosuppressed patients called a PJP pneumonia.

00:20:37:13 - 00:20:43:07
 
Different medical facilities have varying views on the use of Bactrim. Please discuss the use of Bactrim with your medical team.

00:20:45:08 - 00:20:55:05
 
but in general, if you're treating it, if you're looking for other supportive medications, we talked about IVIG, we talked about all the vaccines, we talked about acyclovir.

00:20:55:06 - 00:21:21:05
 
Those are the main things that I tend to do on a regular basis. But I'll have a very less threshold for somebody to start an antibiotic and someone say, for example, if somebody is coughing, sneezing and having acquired an infection very quickly, my threshold to start an antibiotic is very, very quick among patients receiving bispecific antibodies. Otherwise, those infections can be can be really dangerous.

00:21:22:00 - 00:21:28:04
 
In addition to CRS neurotoxicity and increased risk of infections due to hypogammaglobulinemia or cytopenias.

00:21:28:16 - 00:21:31:23
 
The most common side effects of ELREXFIO include tiredness

00:21:32:08 - 00:21:37:22
 
injection side reaction such as redness, itching, pain, bruising, rash, swelling and tenderness.

00:21:38:05 - 00:21:38:18
 
Diarrhea,

00:21:39:01 - 00:21:40:05
 
muscle and bone pain,

00:21:40:12 - 00:21:41:13
 
decreased appetite,

00:21:41:20 - 00:21:42:08
 
rash

00:21:42:15 - 00:21:43:02
 
cough,

00:21:43:08 - 00:21:43:20
 
nausea

00:21:44:04 - 00:21:44:20
 
and a fever.

00:21:45:11 - 00:21:52:12
 
The most common, severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells and platelets.

00:21:52:22 - 00:21:59:14
 
ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS.

00:22:00:05 - 00:22:05:01
 
Tell your health care provider team if you develop any of the following signs or symptoms of a liver problem.

00:22:05:06 - 00:22:05:23
 
Tiredness,

00:22:06:05 - 00:22:07:06
 
loss of appetite,

00:22:07:12 - 00:22:09:17
 
pain in your right, upper stomach area or abdomen,

00:22:09:23 - 00:22:12:04
 
yellowing of your skin, or the white part of your eyes

00:22:12:09 - 00:22:13:05
 
or dark urine

00:22:13:20 - 00:22:25:15
 
Your health care provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

00:22:26:09 - 00:22:29:04
 
These are not all of the possible side effects of ELREXFIO

00:22:30:09 - 00:22:34:07
 
If I had a previous BCMA directed therapy, can I still respond?

00:22:35:06 - 00:23:07:05
 
This is a great question. So we presented this data at ASCO 2023. So what was done at ASCO 2023 was we looked at the magnetismm 4 trials, so we looked at all the patients that have ever received prior BCMA targeting therapy like an ACD,, we talked about belantamab, like CAR-T, the the idacel or ciltacel. So among those patients, what kind of responses are you seeing by using elranatamab

00:23:07:07 - 00:23:32:18
 
So that was a trial that used four different trials. So nine patients from magnetismm 9 studies, 64 patients from magnetismm three study, one patient for magnetismm Two. So we have a pool of patients together. These are close to 87 patients that received elranatamab among those who had received a prior ADC or a prior CAR-T majority of these patients, 59 of them received prior belantamab

00:23:32:20 - 00:24:03:23
 
If you look at those specific responses, you're seeing those responses in close to 42% of patients. Among patients who had seen prior CAR-T, it may have received CAR-T a while ago. They have not been on any continuous therapy. And those are the patients that had the best response you're seeing, 52% of those patients responding. So compare these these responses to to what we had in the past, even from from the past, even from searle from Bella, they were seeing a third of the patients responding here.

00:24:03:23 - 00:24:28:22
 
There are significant number of patients that are responding down the line. I'm not saying that there's no role for searle or bellum. That probably might be happening at a later time, but at this time, these responses among patients are hexoretorefractory. So these patients not only had seen two PIs, two IMiDs and a CD38 monoclonal antibody, they're also have seen a prior BCMA ADC or CAR-T

00:24:29:00 - 00:24:38:03
 
And these patients are who are seeing eight prior lines of therapy are seeing 50% response rates. That means this is a very effective treatment.

00:24:38:03 - 00:24:55:03
 
The PFS benefit that you see among patients who had seen a prior CAR-Ts in the range of around ten months, the PFS benefit that you see among patients that had seen a prior ADC of belantamab was in the range of around five months and patients were living a year after.

00:24:55:03 - 00:25:04:22
 
On an average. When you see patients who are progressing and prior to ADC or a CAR-T. the biggest question that we all have is number one,

00:25:04:22 - 00:25:23:09
 
are the toxicities increased If you're reusing these this CAR-T, this BCMA Bispecific ADC elranatamab. So the answer is no, we did not see an increased risk of CRS. We did not see any increased risk of infections, did not see an increased risk of cytopenias.

00:25:23:11 - 00:25:32:23
 
So it's a very safe drug to be reused in case a chance happens that you have the availability of the drug and this

00:25:32:23 - 00:25:41:05
 
is right in front of you. And this is this is a choice of therapy for patients. who have seen previous ADC or a CAR-T

00:25:41:18 - 00:25:44:04
 
What is the Patient Access Navigator program?

00:25:45:11 - 00:25:51:13
 
If you've been prescribed ELREXFIO, you can receive one on one support from a Pfizer patient access navigator during your treatment.

00:25:52:04 - 00:25:56:14
 
To get support from a patient access navigator enroll in Pfizer Oncology together.

00:25:57:11 - 00:26:03:03
 
After you enroll and opt in, you will be assigned a patient access navigator who will work directly with you and your care team.

00:26:03:18 - 00:26:06:21
 
Patient access navigators can help you access ELREXFIO by

00:26:06:21 - 00:26:15:15
 
Providing details to help you navigate your insurance coverage, including letting you and your care team know how much of your treatment is covered by insurance and what your out-of-pocket costs may be.

00:26:15:17 - 00:26:20:10
 
Connecting you to financial assistance resources if you're eligible, regardless of insurance type.

00:26:21:18 - 00:26:31:21
 
If you need financial assistance to help you pay for your medicine, they can help identify potential resources for patients with commercial insurance, Medicare or government insurance, or those who don't have insurance.

00:26:32:11 - 00:26:36:20
 
Helping you identify solutions if you run into any challenges when accessing your treatment.

00:26:38:11 - 00:26:42:05
 
Patient access navigators can help you as you begin treatment with ELREXFIO by

00:26:42:05 - 00:26:47:15
 
Confirming your hospital's discharge plan with you and your care team if you're receiving your first week's doses at the hospital.

00:26:47:15 - 00:26:51:22
 
And providing you with the information you need to receive treatment at your health care providers office.

00:26:53:01 - 00:27:02:13
 
Patient access navigators can help support you during your treatment with ELREXFIO by coordinating with you to confirm logistics, providing appointment reminders, and following up on insurance needs.

00:27:03:22 - 00:27:07:13
 
Call 18777445671.

00:27:07:13 - 00:27:10:03
 
Or visit PfizerOncologytogether.com