Ms. Lauren Berger: Dr. Mesa, please explain how myelofibrosis is diagnosed.

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1 Ms. Lauren Berger: Hello, I m Lauren Berger, Senior Director of Patient Services Programs at The Leukemia & Lymphoma Society. I m pleased to welcome Dr. Ruben Mesa, Professor of Medicine, Chair of the Division of Hematology and Medical Oncology and Deputy Director of the Mayo Clinic Cancer Center in Scottsdale, Arizona. With Dr. Mesa today is Ms. Emily Knight, an oncology certified registered nurse who is Coordinator of Hematology Patient Care in the Outpatient Setting at the Mayo Clinic. Dr. Mesa and Ms. Knight work together to care for patients with myelofibrosis and other myeloproliferative disorders. Thank you both for joining us today. Dr. Mesa, I'm sure you've seen changes during the time you've treated patients who have myelofibrosis. Can you give us a glimpse of how things have changed over time? Dr. Ruben Mesa: I started at Mayo back in 1991 as a medical student, and one of the first patients I saw in medical school was along with my long-time mentor, Dr. Ayalew Tefferi. With myelofibrosis, we ve really seen an incredible journey. Back in the early 90s when I became involved myelofibrosis, our therapy options were really quite limited, and even our understanding of the disease was really quite limited. We knew that it was a myeloproliferative disorder. We knew that it was a type of chronic leukemia. We had no therapies that had been really developed for myelofibrosis, and we largely looked at therapies for other diseases that we could try against this disease; this disease that would affect people by severely impacting their bone marrow, by having them potentially develop anemia, having significant symptoms, having enlargement of the spleen. We saw how it could really severely affect patients. So with this in my career as I went through internal medicine, hematology, and on the staff at Mayo Clinic, we were involved with perhaps even up to 30 different clinical trials of medicines designed for other reasons, but to see if they could help myelofibrosis. A real watershed moment was back in Several laboratories around the world found a key genetic change, the change in a protein called JAK2. JAK2 is an on/off switch for when cells grow and divide, and is present in about half of those individuals with myelofibrosis and in the majority of patients with myeloproliferative neoplasms. So 2005 really opened up a window in terms of why patients develop myelofibrosis and other myeloproliferative neoplasms. In 2007 began the clinical testing of the first group of drugs specifically targeting these diseases. These are the JAK2 inhibitors. And now in 2012 we have the first approved drug for myelofibrosis, ruxolitinib. So over that period of time, really 2005 through 2012, has really been the most rapid period of both increased understanding of the disease and increasing number of therapy options. Ms. Lauren Berger: Dr. Mesa, please explain how myelofibrosis is diagnosed. Dr. Ruben Mesa: To begin with, first, how do patients find out they have myelofibrosis? Typically it s through one of two ways. One, they re having a general physical, they re having blood tests for some

2 other reason and their physician finds that there s an abnormality in the blood test. They are anemic; their white blood cell count is increased; perhaps their platelets are increased; and they also may feel enlargement of the spleen on exam. These are individuals who don t have any symptoms but are just found to have abnormalities at the time of a physical. The other group of individuals are those who come to seek medical care because they haven t been feeling well. They ve been having fatigue; they ve been having night sweats, fevers, perhaps weight loss. Perhaps their spleen is enlarged and they feel the spleen themselves and think that something is amiss and come to see a physician. When these abnormalities are found, they typically are seen by a hematologist, and a hematologist would typically do a variety of things. First is really a bone marrow. A bone marrow biopsy and aspirate is very important. Myelofibrosis is a type of a chronic leukemia, and the features of which we find from the bone marrow biopsy. We see that there can be scarring in the bone marrow. We see whether there are changes in the genes in the bone marrow. We look at whether there is any change in the cells or the proportion of cells in the bone marrow. We examine the patient with myelofibrosis. Do they have an enlarged spleen? Do they not have an enlarged spleen? We look at blood tests. Is there anemia? Is there an increase in their white cell count or the platelet count? And then finally we do genetic tests to look for mutations in the blood that are associated with myeloproliferative neoplasms, like myelofibrosis, such as the JAK2V617F mutation, or other mutations. The hematologist is then able to look at the constellation of all of these features. And we have formal criteria that they follow through the World Health Organization to first see, does the patient have a blood disease or not? And if they do have a blood disease, is it best characterized as myelofibrosis or is it best characterized as a different type of illness? Ms. Lauren Berger: Dr. Mesa, is it important to have a specialist involved in making the diagnosis? Dr. Ruben Mesa: As we look at the healthcare team, the healthcare team typically involves a general internist, and then a specialist in terms of a hematologist. In the United States, we have our community hematologists and medical oncologists, and they are essential really for the diagnosis of myelofibrosis, both the bone marrow biopsy and coming up with a plan. There also can be perhaps my role, that you might call the subspecialist, the individual who is not only a hematologist, but someone who has chosen to focus on myeloproliferative disorders. But clearly a hematologist needs to be involved to make sure that the diagnosis is accurate and have a good explanation with the patient regarding what the disease means, what are the treatment options, and come up with a treatment plan. In a complex disease like myelofibrosis, it s important to have a good team on your side. And that team can involve a variety of individuals. It involves the core hematologist, who is involved with the care of the patient; the person who is really driving the care in terms of the decision-making for that individual.

3 That team may also involve a subspecialist like myself, someone who focuses on myeloproliferative disorders; maybe visits with the patient at some frequency, to help guide both where the therapy is going but also someone who brings an understanding as to where we stand with experimental drugs and new changes in understandings of the disease. The team can involve the general internist to make sure that the other diseases that a patient might suffer from are well cared for and interact well with the myeloproliferative disease and the therapy. So they might help in terms of coordinating transfusions, they help to keep an eye on the heart and the lungs and the blood pressure, and all of the other issues. And then finally, nursing. As you ll be hearing from my colleague here, Emily Knight, nursing is very important in terms of helping monitor counts in patients with myeloproliferative disorders and myelofibrosis, seeing how they re feeling, seeing how the medicines are responding in the patient, and any difficulties that they re having. Ms. Lauren Berger: What role does age play in treating patients with myelofibrosis? Dr. Ruben Mesa: First, what are the ages of patients with myelofibrosis? The average age at which patients are diagnosed is probably in their late sixties. Yet we ve seen many individuals who are younger, even in their late teenage years, but more commonly in patients who are in their thirties, forties, fifties, and then clearly as we age, sixty and above. We know that age is an important factor for a couple of reasons. One, it has been identified as a risk factor in patients with myelofibrosis. As we age, both the other illnesses that we have and the myelofibrosis itself might be more problematic. Secondly, in terms of age, we know that age is a major factor in terms of determining whether a therapy such as bone marrow or stem cell transplantation, and these two things are relatively synonymous, whether bone marrow transplant should be considered. That s a therapy that we ll be discussing in a moment, but the risk with that therapy has a strong relationship to age. So in terms of treatment, the age has the biggest impact on the decision about bone marrow transplantation. Ms. Lauren Berger: Let s talk now about goals and options for treatment. What do you discuss with a new patient? Dr. Ruben Mesa: Well first I try to describe what is myelofibrosis. So I ve mentioned this term chronic leukemia. A chronic leukemia is different than what we call an acute leukemia. So patients with acute leukemia have significant problems because their blood counts are very low and have risks because of that: a low white count, risk of infection; a low platelet count, risk of bleeding; anemia. Myelofibrosis is one of a few dozen types of chronic leukemias. In this chronic leukemia, I describe for patients that it has both short-term risks and long-term risks. In the short term, it affects people in different ways. It can cause enlargement of the spleen up under the ribcage sometimes to a significant degree that can cause pain or symptoms. It can cause other symptoms: night sweats fevers, chills, weight loss, bone pain, itching. And it can cause anemia.

4 In the long term, the disease can be problematic. It can potentially become a life-threatening disease. Now that depends on many things: the aggressiveness of the disease, as well as the individual s overall health and other medical problems, as well as their age. Also there s a risk that the disease can change as a chronic leukemia to acute leukemia. As I try to discuss goals and treatment options, I really put them in four different levels. They have favorable features in terms of the disease. Maybe we may choose to watch it. There are young patients, or patients with early myelofibrosis, sometimes who live for many years before the disease can progress. The other end of the spectrum is that of bone marrow transplantation that we ll talk about more in a moment. Bone marrow transplantation can cure myelofibrosis, but bone marrow transplantation is a very involved process that carries with it some significant risks and in some ways is life altering, even when successful. So its appropriateness for individuals depends on many things, and is an option probably for the minority of people with myelofibrosis. In between there, there are two groups of therapies. There are currently available therapies. These include therapies that in the past have helped with aspects of the disease. Drugs that have helped anemia, like thalidomide, lenalidomide, or pomalidomide. There are drugs that have helped enlargement of the spleen, like hydroxyurea. And very little that s helped with symptoms. There is now in that category, at least in the United States, approved in November 2011, ruxolitinib, the JAK2 inhibitor. That drug, I was one of the investigators on that trial, and that drug which is now approved, we know helps patients have significant reduction in the size of their spleen, improvement of symptoms. And in our study, compared to placebo, seen that individuals with advanced disease maybe even live longer when they were on that therapy. So that s a very helpful therapy for people with intermediate and high-risk myelofibrosis with a big spleen and symptoms. Now, we still don t have an easy medical cure for the disease. So there still are many experimental drugs that are being tested, and I discuss these drugs with them and the trials that we have ongoing. Clinical trials include other JAK2 inhibitors that are being tested: CYT387, SAR302503, LY , and a whole other variety of agents trying to inhibit JAK2, like ruxolitinib, and see whether they might have a different benefit for patients. There are combination studies with ruxolitinib or other drugs. There are drugs that are working against the fibrosing process in the bone marrow, such as hedgehog inhibitors or LOXL2 inhibitors. And there are other drugs looking at acute leukemia or other related diseases to see whether they can have a bigger impact. So there is tremendous energy around the world trying to find better therapies for myelofibrosis. So I really try with my discussion with a patient with myelofibrosis. Where do you stand on that spectrum of risk with the disease? What are the options? What are your goals? And how do they best fit with your goals and where your disease stands?

5 Ms. Lauren Berger: Now going onto assessing treatment, what questions should a patient ask their doctor to help them get the best treatment, including consideration of clinical trials? Dr. Ruben Mesa: I think with myelofibrosis, as I ve just described, we don t have one medicine that acts as a magic wand and takes the disease away. So I think we have to be very specific in terms of what are the goals of a therapy when we utilize them. If we have medicines that are looking to try to improve anemia, do they improve anemia? A patient should ask their doctor when they start a therapy: What is the goal of the therapy? How do we know whether it s working? How long will it take for me to know whether it s working? Because there are some medicines that we might expect a benefit within two months, some that might take six months. So all of these are important issues. With our approved medicine of ruxolitinib, likewise, we know that medicine can help improve symptoms, it can improve enlargement of the spleen, it might help improve even the life expectancy with the disease. So again when I see a patient with the disease, if they re on that therapy, has their spleen shrunk? Do they feel better? And then I ask clearly, if you re on a medicine, has that medicine been beneficial or has that medicine caused any side effects that are of concern? Do we need to adjust the dose? And then finally, if we re looking at our most aggressive therapy of transplantation, the goals are different, but the concept is the same. What is the goal? There the goal is the cure, and there the bar (in terms of perhaps what we re both willing to put up with) is higher because of the significant goal that we have. From the patient s end I think the key things that they need to really be asking their doctors: The drug, the goal, the time. And then if it doesn t achieve that, what are the other options that we have versus what might be expected in a drug that s in a clinical trial. Ms. Lauren Berger: Thank you Dr. Mesa. How do you determine whether a treatment is working? Dr. Ruben Mesa: The key again really comes down to goals. We have a series of criteria through the International Working Group for Myelofibrosis Research and Treatment, somewhat of a collaboration between international physicians who have worked together on myelofibrosis, to determine what is a response, what is benefit. If you were needing transfusions before of red blood cells, do you no longer need transfusions, or is your hemoglobin now back to normal? If you had a lot of symptoms, are the symptoms much less? Are they much less of a factor for you? Has your quality of life improved? If your spleen was enlarged, has it shrunk by at least half in size? And if so, do you feel better because of it? If the goal of the therapy were to improve the disease and how the bone marrow looks in terms of scarring or other changes, we will repeat those tests and see whether those things have improved. So we really assess why was a treatment started and did it achieve the goal that we anticipated. And likewise, as we monitor the patient with the disease on the therapy, do we continue to maintain that benefit, or if we start to lose that benefit, do we need to adjust the dose of that medicine that a patient is on or do we need to consider an alternative medicine? Or a clinical trial? Or in the patient

6 that is a candidate for a bone marrow transplant, has the disease progressed and we need to consider something even more aggressive, like transplantation? Ms. Lauren Berger: When is a stem cell transplant or a bone marrow transplant an option for a patient? Dr. Ruben Mesa: Myelofibrosis is the disease in the bone marrow that the only way we can get rid of the disease permanently is to try to clean out the bone marrow and give the bone marrow from someone else. The patient, in a bone marrow transplant, receives chemotherapy in a level that helps to clean out the bone marrow. They then receive, after a few days of this chemotherapy, the cells from someone else, from a donor. The donor is someone who is a match. So we typically look at brothers or sisters who have the same mother and father, or if not, we look for an unrelated donor through the International Registry. They then receive the cells, and these cells can be collected from the donor from their blood. They receive shots and we collect the cells in their blood. We harvest those cells and give them back to the patient. That s a stem cell transplant. The patient receives the cells. It typically takes about three to four weeks for these cells to find their way home and to slowly start to grow and to make more of the cells that we need. It s like a plant. When you move a plant from one pot to the other, it takes a while to start to grow, and likewise, it takes a while for the bone marrow to make more red cells, white cells, and platelets. Now that therapy carries with it a significant risk. And that risk can be passing away from complications from the transplant, either in the short term or the long term. So the real question is, who should be transplanted for myelofibrosis? It s a question none of us know for certain. We know there are several factors. One, we know age is probably the biggest factor. As we age, particularly in our mid-sixties and above, the risk climbs very significantly. So that it really is a therapy that is rarely considered above the age of 70. There can be exceptions in individuals with exceptional physiologic age in terms of how strong they are. But there is a point at which age alone prohibits stem cell transplantation. We also look at other factors. How aggressive is the myelofibrosis? I typically offer it to patients who I think their life expectancy is probably less than five years given the risks that come with bone marrow transplant. We look to see whether they have a donor and how good a match that donor might be. And we look to see how good the rest of their health is. The healthier the rest of their body is, the better they would tolerate the process of going through a bone marrow transplant. And then finally, philosophically, where does a patient stand? There are patients who wish to try to go for the cure, almost regardless of the risk. And other patients, who hearing the process of bone marrow transplantation, will choose that that is not the best option for them.

7 So it s quite a complex process. In our clinic here, we typically have patients visit with both myself and my colleague, Dr. Veena Fauble, who focuses on bone marrow transplantation, so that patients can get a full spectrum of their options, and then we circle back as a team and try to decide on that spectrum what therapy should be the best initial approach for the patient with myelofibrosis. Ms. Lauren Berger: Emily, let s talk about communication between patients and their oncology team. What advice do you give patients about communicating with their doctor and nurse about symptoms and side effects? Ms. Emily Knight: When I first meet with patients, I try to get an understanding of the symptoms that they experience from their disease and how it affects their daily life. And then if Dr. Mesa should prescribe new medications for them to help control those symptoms that they experience, I ll review the medicines and talk about how it will help improve the symptoms from the disease, but also possible side effects they may have from the medicines. I encourage patients to be very open with communication. They need to call us or communicate with us about any problems that they may have. Dr. Ruben Mesa: Now Emily, I find sometimes after I ve given the patients the whole discussion of myelofibrosis, it can be a little overwhelming. Is there anything with interacting with patients that you advise them might be helpful in terms of the visits with us that might help them remember things for the future? Ms. Emily Knight: Yeah, I do. I encourage patients before they come to see you to write down a list of questions that they have. That way when it comes to the end of the visit, if you haven t touched on some of the things, they can then just ask you from their list of questions. Also I encourage them to bring a family member or friend who can be there as a second set of ears and support for them. Dr. Ruben Mesa: Something interesting with that last one, I found that perhaps with new technologies that have been helpful: I ve seen patients perhaps a bit more computer savvy, who have brought in their ipads or similar tablets and have the Face Time; sometimes I literally have the family member sitting there on the desk with me if they re from a distance; or I ve also seen people do Skype, where they come in and they have the computer and they have mom up on Skype. So I think you can be creative. I think from the healthcare team, myself, and I m sure I speak for other colleagues. You know it s a lot of information. I think having family members there, whether they re physically sitting there or whether they are virtually there, can be very helpful. Ms. Emily Knight: Yes, I agree. Ms. Lauren Berger: What concerns should patients call you about in between visits? And are patients sometimes reluctant to bring up their side effects about how they're feeling because they're concerned that the therapy might be decreased or discontinued?

8 Ms. Emily Knight: I encourage patients to call with concerns about their lab values, problems with side effects from the medications, or worsening symptoms from their disease. Patients are usually open about the side effects they are experiencing from the medication, as oftentimes different medications can be prescribed or adjusting the dosage of their current medication that they re on. Dr. Mesa, what additional questions do you get from patients? Dr. Ruben Mesa: I think patients frequently are a little confused at the start as to the logistics. Have the discussion with them. What s myelofibrosis? What s the treatment plan? Let s say we start them on a therapy; let s say it is ruxolitinib. They want to know, How are we monitoring that? I come from a distance. So discuss that you re going to come in, we re going to set them up for lab values at home, so we re going to be checking a blood count on a weekly basis. We re going to be monitoring for your side effects, and if they have side effects, they re going to give you a call, whether they have any unexpected side effects with the medicine at all. They re going to ask me, What are you looking for on those blood tests? We re going to look at them, see whether those blood counts are normal or they re abnormal. If they needed red blood cell transfusions before, do they change to some threshold that would trigger a transfusion? Then they ask if they need a transfusion, How do we arrange for that? Do you and I order that here at Mayo Clinic? Are they from another area? Do we ask their doctor to give them a transfusion at home? And then they always want to know, How long might a therapy work? And then, when we will be visiting with them again to assess? Is it in a month? Is it in two months? Are they coming from another country and it s in six months? I think it s all of these logistical points, which is why I think we make such a good team with this, because there s a lot to follow and I think we clearly need to work together as a team to be able to track all of the things that we keep track of. We track the spleen size, we track the symptoms, we track the blood counts, we track the transfusions. So that when the patient comes back we re both on the same page kind of where they ve been. Has the therapy been helping? Do we need more? Do we need less? Do we need something different? Is there a new medical problem that popped up? These are important things I think that they ask about. Ms. Lauren Berger: And Emily, what advice do you have for patients who feel depressed or have financial pressures? Ms. Emily Knight: In regards to financial pressures, I would encourage patients to contact their nurse who can oftentimes get them in touch with assistance programs. A lot of the specialty medications that we use can be very expensive, and it s important for them to know that there are resources out there and available to assist with high co-pays. In regards to feeling depressed, I let patients know that it s not abnormal, they may feel depressed at times. But it s important that they have support, whether it be the nurse or family members who they can talk to about their feelings.

9 Dr. Mesa and I make sure that they have support at home and around them. We would refer patients to social workers or psychologists to help manage anxiety and depression that many cancer survivors experience. Ms. Lauren Berger: Is there anything else you want patients to know about talking to their healthcare team, their doctor, their nurse, social worker, or anyone else about some of their symptoms and just what they're going through during their cancer experience? Ms. Emily Knight: Our patients are really good about calling us and ing us and keeping us informed and that s very important. I would want all patients to know that they should call and keep in touch with their nurses and their doctors, so that they know what's going on and how they re feeling. If our patients don t call us and tell us how they re feeling, we often don't know. We do get frequent blood work, but if the blood work shows that their labs are normal, we don t know how the patient is feeling unless they call and tell us. Ms. Lauren Berger: Dr. Mesa, what are the other challenges of having an illness like this? Dr. Ruben Mesa: Well I d say there s a couple things. I d say that one is the mystery around the disease. If a patient has myelofibrosis, when they go to a co-worker, when they go even to a spouse or family member or other loved ones, that individual doesn t really know how to put that disease in context. If a woman tells their co-worker, their boss, that they have breast cancer, (a) of course they re very sympathetic; but they have some framework in which to put that. In myelofibrosis, it s a complex disease. Frequently the patients, when they re diagnosed, they ve not heard of it before. So that part can be isolating and that s where education can be incredibly helpful. I think even a video such as this. If a patient has the disease and they can point their boss or their loved one to watch such a video, or some of the YouTube videos that I ve put out on the internet, these things can be helpful to provide some information, some explanation, so that it is less isolating. The second key component, I think, is really a sense of community. We ve found that diseases like MPNs, like other chronic illnesses, have in the age of the internet, really helped to build tremendous online communities, whether they be through computer blogs or list-serves, whether it be with face-toface patient meetings, whether it be with the tremendous educational resources or support meetings that The Leukemia & Lymphoma Society has for patients with blood cancers. So I think all of these things, a sense of community can be very helpful with a disease sometimes that is confusing for the individual. Also in a disease like this, there s always the uncertainty about the future. I ve described for you a future that hopefully is very bright, where we are learning much more about the diseases, where we re making the impact on therapies, where even over the last five years we have many more options now than we had before. But still the patient who sits in front of me today with myelofibrosis clearly may have the challenge that they do not know what the future holds. So that challenge is a significant one. And I think walking along that road hand in hand with other patients who are experiencing the challenge is incredibly helpful. And hopefully people like myself and Emily and our healthcare team, as well as others, we

10 walk along with patients as they walk through this difficult road and hopefully make the journey a little easier. Ms. Lauren Berger: The Leukemia & Lymphoma Society is committed to providing education, support and guidance to people living with blood cancer. If you would like more information on what you ve heard, or for other education materials or support, we encourage you to contact an information specialist at The Leukemia & Lymphoma Society by calling toll-free , or us at We would like to acknowledge and thank Incyte Corporation for their support, which helps LLS to bring you this information. We hope this presentation was helpful. Please click on the evaluation button on your screen to give us your feedback. Your responses will help us to plan better programs and services to meet your needs. On behalf of The Leukemia & Lymphoma Society, thank you for joining us today. We wish you well.

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