Selected Podcast
When to Refer for CAR T-Cell Therapy
In this three-person panel, Dr. David Maloney, Katie Gieseke, and Hannah Alo explain CAR T-cell therapy, why someone would need this, and when someone should be referred to it.
Featuring:
Katie Gieseke is an SCCA IMTX Advanced Practice Provider.
Hannah Alo | Katie Gieseke | David G. Maloney, MD, PhD
Hannah Alo is an SCCA IMTX Advanced Practice Provider.Katie Gieseke is an SCCA IMTX Advanced Practice Provider.
David G. Maloney, MD, PhD is the Seattle Cancer Care Alliance Medical Director of Cellular Immunotherapy.
Learn more about David G. Maloney, MD, PhD
Learn more about David G. Maloney, MD, PhD
Transcription:
Aimee Martin (Host): [00:00:00] Welcome to the Oncology Sound Byte, a podcast produced by the Seattle Cancer Care Alliance, designed to offer byte-sized audible oncology education from one of the top cancer treatment centers in the nation. I'm your host Aimee Martin, a Senior Physician Liaison at the Seattle Cancer Care Alliance. During this episode, we will focus on CAR T Cell Therapy which is a game changer in the field of cellular immunotherapy. With us to share more on this hot topic in the cancer treatment world, are three members of SCCA's Cellular Immunotherapy Group. Dr. David Maloney, the Medical Director of Cellular Immunotherapy at SCCA. Hannah Alo, an Advanced Practice Provider and Katie Gieseke, who also serves as an Advanced Practice Provider. Welcome to the show.
Hannah Alo, APP: [00:00:54] Hey, thank you for having us.
Katie Gieseke, APP: [00:00:55] Hi, Amy. Thanks for having us.
Host: [00:00:57] Yes, thank you. Thanks for joining. I want to jump in with my first question to Dr. Maloney. Can you give us an overview of the program and the FDA approved CAR T Cell Therapies that are currently available?
David G. Maloney, MD, PhD (Guest): [00:01:11] Yes. Thank you very much. You know, as you know, we opened the clinic in late 2016 and it's one of the first clinics of its kind dedicated to delivering cellular immunotherapy. In the four years or so, we've been open, we've been really delighted to have three drugs approved or CAR T Cell Therapies approved for patients with leukemia or lymphoma.
So, currently the clinic is offering tisagenlecleucel which is KYMRIAH. And that's approved for the treatment of patients, pediatric and young adult patients up to the age of 26, with ALL and it is also approved for relapsed and refractory diffuse large B cell lymphoma after two prior regimens.
And we also have axicabtagene ciloleucel or YESCARTA and this is the CAR that we've been predominantly using for the treatment of patients with aggressive diffuse large B cell lymphoma. Again, in that second relapse setting or later. And then recently the FDA approved, which is essentially the same as axicabtagene ciloleucel, with slightly different manufacturing techniques.
And this is also called TECARTUS, and this was approved for the treatment of relapsed mantle cell lymphoma, pretty much regardless of any other prior therapy. So, we have quite a mixed bag of treatments, really targeting lymphoma at this point. But, with the future being very bright for more to come.
Host: [00:02:33] Dr. Maloney at what point should a provider refer their patient to SCCA, and can you talk a little bit more about the difference in outcomes when the patient is treated earlier in the course of their disease?
Dr. Maloney: [00:02:46] Well that's a great, great question. What we have learned so far is that patients who have the least amount of disease, tend to have better outcomes and they tend to have less toxicity with the therapy. So, that's pretty much it in a nutshell. So, if you're thinking about referring patients, if you can get the patients to CAR T Cell Therapy before they have absolutely refractory disease and very bulky lymphadenopathy, then it's very likely that the outcome will be better and that they'll have less toxicity through the process. And the two major toxicities we see are cytokine release syndrome and neurologic toxicity. And they both seem to be decreased in patients who have less disease bulk. So, if you're just thinking about referring patients for this therapy which we think can be curative in a substantial fraction of patients, then it's better to think about it before you've exhausted every possible treatment option and refer them when they're eligible. Currently all of these products are really require two prior regimens for the aggressive lymphomas. So, that means a lack of response or a relapse after a first salvage or the second line treatment is the time to start thinking about that. Now we also have clinical trials ongoing across the country that are evaluating CAR T cells compared to the autologous STEM cell transplant for patients in the first relapse. And so there was the possibility that you know in a year or so we might be in a situation where CAR T cells can even be offered in first relapse patients. But right now it should be as early as possible after you've given you a second line therapy and the patient then if the patient is not an appropriate candidate for transplant, they should be referred for CAR T Cell Therapy.
Host: [00:04:25] My next question is for Katie. What does the patient need to know before coming for treatments and what can they expect?
Katie Gieseke, APP: [00:04:33] Hannah and I are the Immunotherapy Intake Coordinators and we are going to be the patient's primary point of contact prior to their arrival to SCCA for CAR T-cell therapy. So, once these patients are referred into the system and their arrival date has been confirmed, the Immunotherapy Intake Coordinator will reach out to the patient to discuss the details of CAR T Cell Therapy, what to expect, requirements of therapy and we'll connect the patient to available resources as needed. So, as far as timeline, in general, CAR T Cell Therapy is two to two and a half month commitment from time of arrival to the time of their discharge. However the length of stay may be extended further depending on the patient's clinical condition and the response to treatment. Patients will arrive to the Immunotherapy Clinic and will go through an initial screening period which is anywhere from one to two weeks.
After this period, if the patient is cleared to proceed, they will have their leukapheresis which is the cell collection procedure. And their cells will go into manufacturing to be made into the CAR T Cell Product. And this manufacturing period is roughly three weeks. Once these cells are ready for infusion, the patient will typically get three days of lymphodepleting chemotherapy. Then have two days of rest without any treatment and will then proceed with their CAR T Cell Infusion. This CAR T Cell infusion can be given in the outpatient setting or in the hospital setting depending on the requirements of the clinical trial or the specific commercial product requirements. And then the patient will remain on the Immunotherapy Service for a minimum of 30 days following their CAR T Cell infusion for monitoring, evaluation and restaging prior to being discharged back to their home oncologist.
So, that's just an overview of kind of a timeline too for patients to expect. But as far as patient requirements, patients are asked to stay within 30 minutes of the treatment facility for 30 days following their CAR T Cell infusion and are required to have a caregiver 24 hours a day during this time. And it's also recommended that the patient bring their caregiver to appointments prior to treatment to meet the care team and learn about the treatment plan. In addition to some of these requirements, we would like to share some resources available for patients. We have patient financial services to assist with the financial clearance component of this and coordination with insurance companies. We have the housing department to assist patients with securing their local housing either through the SCCA House, Pete Grosz House or connecting with local hotels are short-term rental options if preferred. And then we have social work to further assist with connecting patients with available resources such as housing or travel grants, caregiver agencies, childcare services, transportation resources and so on.
Host: [00:07:12] And this last question is to Hannah. How do you refer a patient into the system?
Hannah: [00:07:18] Yeah. So, patients can be referred to the Cellular Immunotherapy Program through essentially three different pathways. They can be referred by their providers or self-refer. So, firstly providers outside of the SCCA group can refer their patients through four different routes. Number one, by calling the number, the main number for intake, where they will be transferred to the Immunotherapy Patient Care Coordinators. Two, providers can go to the SCCA website and request a referral electronically.
Three, they can fax or email a referral or four, if the provider is familiar with our program and has the contact information for the Immunotherapy Intake APPs being either myself or Katie, or an SCCA provider, they can submit their request that way. The second pathway is for internal SCCA providers. They can refer their patients by the same methods that I just mentioned previously. However, more commonly, they will contact the Immunotherapy Intake APPs again, Katie or myself, or the Immunotherapy Patient Care Coordinators directly. So, the third and last pathway is for patients who are self-referred.
They can call the main SCCA number and speak with the Patient Care Coordinator, or they can visit the website and submit an online appointment request. So, once a referral is received, the Patient Care Coordinators will request patient records so the intake APPs can review them. Depending on the patient's disease and history, they may be eligible for one or more treatment options such as a commercial product or clinical trial. So, after reviewing the case and assessing eligibility status, Katie or I will reach out to Dr. Maloney or the PI of the clinical trial and review the case. If the patient is an appropriate candidate, we'll make a group decision on whether the patient needs to be seen for a consult or if they can arrive directly to the program for a pre-treatment evaluation. If the patient is not eligible for whatever reason, the Immunotherapy Intake APPs will reach out to the patient or provider to discuss it. If they're not deemed eligible at this time but maybe in the future, in which case we may able to provide some advice or recommendations.
Host: [00:09:11] Wow. Lots of great options for providers to refer into the system. Thank you so much for talking us through that and for more information on how to make a referral, check out our provider facing blog which can be found by visiting Seattlecca.org/providerblog. While there, sign up to subscribe to our e-newsletter to receive updates on our future podcast episodes along with other news out of SCCA. Thank you so much for joining me today Dr. Maloney, Hannah and Katie and thanks to our listeners for tuning in to the Oncology Sound Byte. Until next time, thanks for listening and take good care.
Since the recording of this episode, lisocabtagene maraleucel or Breyanzi has been approved by the FDA for relapsed or refractory large B-cell lymphoma. The Seattle Cancer Care Alliance is an authorized treatment center for this CAR T product. For more information on the Besos Family Immunotherapy Clinic, please head to our website Seattlecca.org.
Aimee Martin (Host): [00:00:00] Welcome to the Oncology Sound Byte, a podcast produced by the Seattle Cancer Care Alliance, designed to offer byte-sized audible oncology education from one of the top cancer treatment centers in the nation. I'm your host Aimee Martin, a Senior Physician Liaison at the Seattle Cancer Care Alliance. During this episode, we will focus on CAR T Cell Therapy which is a game changer in the field of cellular immunotherapy. With us to share more on this hot topic in the cancer treatment world, are three members of SCCA's Cellular Immunotherapy Group. Dr. David Maloney, the Medical Director of Cellular Immunotherapy at SCCA. Hannah Alo, an Advanced Practice Provider and Katie Gieseke, who also serves as an Advanced Practice Provider. Welcome to the show.
Hannah Alo, APP: [00:00:54] Hey, thank you for having us.
Katie Gieseke, APP: [00:00:55] Hi, Amy. Thanks for having us.
Host: [00:00:57] Yes, thank you. Thanks for joining. I want to jump in with my first question to Dr. Maloney. Can you give us an overview of the program and the FDA approved CAR T Cell Therapies that are currently available?
David G. Maloney, MD, PhD (Guest): [00:01:11] Yes. Thank you very much. You know, as you know, we opened the clinic in late 2016 and it's one of the first clinics of its kind dedicated to delivering cellular immunotherapy. In the four years or so, we've been open, we've been really delighted to have three drugs approved or CAR T Cell Therapies approved for patients with leukemia or lymphoma.
So, currently the clinic is offering tisagenlecleucel which is KYMRIAH. And that's approved for the treatment of patients, pediatric and young adult patients up to the age of 26, with ALL and it is also approved for relapsed and refractory diffuse large B cell lymphoma after two prior regimens.
And we also have axicabtagene ciloleucel or YESCARTA and this is the CAR that we've been predominantly using for the treatment of patients with aggressive diffuse large B cell lymphoma. Again, in that second relapse setting or later. And then recently the FDA approved, which is essentially the same as axicabtagene ciloleucel, with slightly different manufacturing techniques.
And this is also called TECARTUS, and this was approved for the treatment of relapsed mantle cell lymphoma, pretty much regardless of any other prior therapy. So, we have quite a mixed bag of treatments, really targeting lymphoma at this point. But, with the future being very bright for more to come.
Host: [00:02:33] Dr. Maloney at what point should a provider refer their patient to SCCA, and can you talk a little bit more about the difference in outcomes when the patient is treated earlier in the course of their disease?
Dr. Maloney: [00:02:46] Well that's a great, great question. What we have learned so far is that patients who have the least amount of disease, tend to have better outcomes and they tend to have less toxicity with the therapy. So, that's pretty much it in a nutshell. So, if you're thinking about referring patients, if you can get the patients to CAR T Cell Therapy before they have absolutely refractory disease and very bulky lymphadenopathy, then it's very likely that the outcome will be better and that they'll have less toxicity through the process. And the two major toxicities we see are cytokine release syndrome and neurologic toxicity. And they both seem to be decreased in patients who have less disease bulk. So, if you're just thinking about referring patients for this therapy which we think can be curative in a substantial fraction of patients, then it's better to think about it before you've exhausted every possible treatment option and refer them when they're eligible. Currently all of these products are really require two prior regimens for the aggressive lymphomas. So, that means a lack of response or a relapse after a first salvage or the second line treatment is the time to start thinking about that. Now we also have clinical trials ongoing across the country that are evaluating CAR T cells compared to the autologous STEM cell transplant for patients in the first relapse. And so there was the possibility that you know in a year or so we might be in a situation where CAR T cells can even be offered in first relapse patients. But right now it should be as early as possible after you've given you a second line therapy and the patient then if the patient is not an appropriate candidate for transplant, they should be referred for CAR T Cell Therapy.
Host: [00:04:25] My next question is for Katie. What does the patient need to know before coming for treatments and what can they expect?
Katie Gieseke, APP: [00:04:33] Hannah and I are the Immunotherapy Intake Coordinators and we are going to be the patient's primary point of contact prior to their arrival to SCCA for CAR T-cell therapy. So, once these patients are referred into the system and their arrival date has been confirmed, the Immunotherapy Intake Coordinator will reach out to the patient to discuss the details of CAR T Cell Therapy, what to expect, requirements of therapy and we'll connect the patient to available resources as needed. So, as far as timeline, in general, CAR T Cell Therapy is two to two and a half month commitment from time of arrival to the time of their discharge. However the length of stay may be extended further depending on the patient's clinical condition and the response to treatment. Patients will arrive to the Immunotherapy Clinic and will go through an initial screening period which is anywhere from one to two weeks.
After this period, if the patient is cleared to proceed, they will have their leukapheresis which is the cell collection procedure. And their cells will go into manufacturing to be made into the CAR T Cell Product. And this manufacturing period is roughly three weeks. Once these cells are ready for infusion, the patient will typically get three days of lymphodepleting chemotherapy. Then have two days of rest without any treatment and will then proceed with their CAR T Cell Infusion. This CAR T Cell infusion can be given in the outpatient setting or in the hospital setting depending on the requirements of the clinical trial or the specific commercial product requirements. And then the patient will remain on the Immunotherapy Service for a minimum of 30 days following their CAR T Cell infusion for monitoring, evaluation and restaging prior to being discharged back to their home oncologist.
So, that's just an overview of kind of a timeline too for patients to expect. But as far as patient requirements, patients are asked to stay within 30 minutes of the treatment facility for 30 days following their CAR T Cell infusion and are required to have a caregiver 24 hours a day during this time. And it's also recommended that the patient bring their caregiver to appointments prior to treatment to meet the care team and learn about the treatment plan. In addition to some of these requirements, we would like to share some resources available for patients. We have patient financial services to assist with the financial clearance component of this and coordination with insurance companies. We have the housing department to assist patients with securing their local housing either through the SCCA House, Pete Grosz House or connecting with local hotels are short-term rental options if preferred. And then we have social work to further assist with connecting patients with available resources such as housing or travel grants, caregiver agencies, childcare services, transportation resources and so on.
Host: [00:07:12] And this last question is to Hannah. How do you refer a patient into the system?
Hannah: [00:07:18] Yeah. So, patients can be referred to the Cellular Immunotherapy Program through essentially three different pathways. They can be referred by their providers or self-refer. So, firstly providers outside of the SCCA group can refer their patients through four different routes. Number one, by calling the number, the main number for intake, where they will be transferred to the Immunotherapy Patient Care Coordinators. Two, providers can go to the SCCA website and request a referral electronically.
Three, they can fax or email a referral or four, if the provider is familiar with our program and has the contact information for the Immunotherapy Intake APPs being either myself or Katie, or an SCCA provider, they can submit their request that way. The second pathway is for internal SCCA providers. They can refer their patients by the same methods that I just mentioned previously. However, more commonly, they will contact the Immunotherapy Intake APPs again, Katie or myself, or the Immunotherapy Patient Care Coordinators directly. So, the third and last pathway is for patients who are self-referred.
They can call the main SCCA number and speak with the Patient Care Coordinator, or they can visit the website and submit an online appointment request. So, once a referral is received, the Patient Care Coordinators will request patient records so the intake APPs can review them. Depending on the patient's disease and history, they may be eligible for one or more treatment options such as a commercial product or clinical trial. So, after reviewing the case and assessing eligibility status, Katie or I will reach out to Dr. Maloney or the PI of the clinical trial and review the case. If the patient is an appropriate candidate, we'll make a group decision on whether the patient needs to be seen for a consult or if they can arrive directly to the program for a pre-treatment evaluation. If the patient is not eligible for whatever reason, the Immunotherapy Intake APPs will reach out to the patient or provider to discuss it. If they're not deemed eligible at this time but maybe in the future, in which case we may able to provide some advice or recommendations.
Host: [00:09:11] Wow. Lots of great options for providers to refer into the system. Thank you so much for talking us through that and for more information on how to make a referral, check out our provider facing blog which can be found by visiting Seattlecca.org/providerblog. While there, sign up to subscribe to our e-newsletter to receive updates on our future podcast episodes along with other news out of SCCA. Thank you so much for joining me today Dr. Maloney, Hannah and Katie and thanks to our listeners for tuning in to the Oncology Sound Byte. Until next time, thanks for listening and take good care.
Since the recording of this episode, lisocabtagene maraleucel or Breyanzi has been approved by the FDA for relapsed or refractory large B-cell lymphoma. The Seattle Cancer Care Alliance is an authorized treatment center for this CAR T product. For more information on the Besos Family Immunotherapy Clinic, please head to our website Seattlecca.org.