Sponsored by Bristol Myers Squibb
In 2019, Karla, a native of Parker, Arizona, began to experience back pain, which would be expected with a decades-long active lifestyle and full social calendar. But when her pain escalated, she was flown to Barrow Neurological Institute for evaluation where a CT scan revealed a malignant tumor on her spine. Emergency surgery was performed to remove the mass, but in the process, doctors noticed pockets of cells that were later diagnosed as non-Hodgkin’s Lymphoma.
Read MoreBut within a year, she began experiencing fatigue and loss of appetite. She suspected the cancer was back; unfortunately, she was right, and her oncologist confirmed her suspicion with a PET scan —Karla’s cancer had relapsed. “I had learned from my previous experience to listen to my body, and I just knew that the cancer was back. When my doctor confirmed, I just kept thinking, ‘what is the next thing we have to do?’”
In LBCL, up to 40% of patients have disease that is either resistant to initial therapy or relapses (comes back).2 After a relapse, a stem cell transplant may be used to treat LBCL.3
Karla was referred to the bone marrow transplant unit, where for the first time, she heard of CAR T cell therapy. Her doctor explained that when LBCL relapses after only a short timeframe as Karla’s had, a stem cell transplant is less likely to work.2 Her doctor offered another option: enroll in a clinical trial for CAR T cell therapy, to treat her relapsed LBCL.
She weighed the options with her doctor, an emotional conversation she recalls, knowing the future might entail an ongoing cycle of relapse and chemotherapy if she proceeded with the stem cell transplant.
“This therapy meant getting a second chance.”
The treatment becomes personal(ized)
Autologous chimeric antigen receptor (CAR) T cell therapy, like Breyanzi (lisocabtagene maraleucel), is a personalized treatment that harnesses the power of a patient’s own T cells (disease-fighting immune cells) and reprograms them to fight cancer.4 After a one-time infusion, the CAR T cells can continue to multiply and fight the cancer.5 The doctor explained that the treatment process could take approximately 2-3 months and includes leukapheresis (removal of white blood cells from the blood), manufacturing, administration, and adverse event monitoring.
Breyanzi is FDA approved for adults when their first treatment has not worked or their cancer returned within a year of their first treatment OR when their first treatment has not worked or their cancer returned after the first treatment and are not eligible for hematopoietic stem cell transplantation because of medical conditions or age OR two or more kinds of treatment have not worked or stopped working.
Please see the Important Safety Information below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities (NT), and Secondary Hematologic Malignancies.
Read more about how Breyanzi works, how you can receive it and what support may be available:
“She explained that they would remove the blood cells. These cells would then be, after a process, returned to me as the CAR T cell therapy treatment. She said to think of them as little soldiers that are there to help kill the cancer cells. The cells that were altered would recognize cancer cells, as well as some healthy cells, and attack them. My doctor was such a believer in this clinical trial and her passion for the therapy was inspiring.”
Karla enrolled in the clinical trial.
They discussed the possible side effects that are life-threatening or fatal, such as cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies, as well as other common side effects, including fever, low white or red blood cells, severe diarrhea, or severe nausea.
She moved three hours away to Phoenix and recounts the move as the hardest part. Friends and family came together as a team of caregivers who rotated to stay with her to provide 24-hour care and she was grateful to have them by her side.
Karla was also astonished by the clinical staff’s dedication. “I can’t even tell you the kindness of these total strangers that devote their life to prolonging mine. They watched everything, from my temperature to my behavior and my diet. That constant care was important.”
The CAR T cell therapy treatment, Breyanzi, had already been approved for use in adults with LBCL when two or more kinds of treatment have not worked or stopped working. This trial would confirm whether it could be used a step earlier in the treatment journey, after just one previous therapy – like in Karla’s case. She struggled with being so far from home, but she found peace knowing her involvement was going to make a difference for others regardless of the outcome. To her, taking part in a clinical trial meant more than just accessing a potential new treatment—it meant helping future people diagnosed with relapsed or refractory LBCL. “I felt like I was helping humanity in a small way.”
Karla’s medical team shared her excitement about the clinical trial because it was also an opportunity for them to treat the first patient at their clinic with CAR T cell therapy. She recalls having the whole team gathered around her during the infusion. “I just felt like this is going to work.”
She remained entirely positive throughout the experience, even when she had complications like an infection at the port where her medicine was administered. Karla stayed in the hospital after treatment to be monitored in case she experienced side effects. Her healthcare team took her temperature and monitored her bloodwork closely. Side effects with Breyanzi treatment will vary from patient to patient. Breyanzi can cause side effects that may be life-threatening and can lead to death, such as cytokine release syndrome and neurologic toxicities and secondary hematologic malignancies. Because of the risk of cytokine release syndrome, neurologic toxicity, and other side effects, patients like Karla must remain at, or close to, where they received treatment for at least 4 weeks after the infusion for side effect monitoring. Karla was just waiting for the good news when she could finally return home.
February 11, 2021. A date Karla says she will always remember. Her daughter and grandchildren picked her up, and what was once a typical “boring” desert drive home, was more special than ever.
Life after CAR T cell therapy
Today, Karla is still in remission. She goes to lunch with her friends, takes care of her house and remains very involved with her family. She has taken to listening to audiobooks. While the scans Karla gets every 6 months show that she is in remission, it does not mean she’s cancer free. Karla continues to be monitored for possible disease recurrence and long-term side effects from CAR T cell therapy.
Data from the clinical trial that Karla participated in, called TRANSFORM, was used to obtain FDA approval for Breyanzi as a second-line treatment for LBCL. That means because of that clinical trial and participation from patients like Karla, people who have LBCL that do not respond to initial chemotherapy or relapse within a year can now be treated with Breyanzi, if a bone marrow transplant is not a good option for them.
To find a cell therapy treatment center near you, please visit:
Looking back, Karla recalls what got her through two battles against cancer.
“Number one, trust your medical team.” When making treatment decisions it is important to have a medical team that can speak in layman’s terms to make sure you understand and feel comfortable. “Knowledge is power. You need to know what is happening with your own body.”
Second, caregivers are important not only for helping you through your treatment journey, but also for monitoring you and raising concerns when anything seems off – they can pick up on things that you may not realize. While reluctant to ask or accept the help, Karla can now say to others, “Learn to take the help and be grateful. That’s all you can do.”
She is grateful to have been part of the clinical trial and while she recognizes her experience and outcome may not be the same for everyone on CAR T cell therapy, she wants to encourage other patients to consider Breyanzi with their medical team.
Why?
“I’m living proof.”
To learn more about Breyanzi, please visit https://www.breyanzi.com/
Important Safety Information
What is the most important information I should know about BREYANZI?
BREYANZI may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:
• difficulty breathing
• fever (100.4°F/38°C or higher)
• chills/shaking chills
• confusion
• severe nausea, vomiting, diarrhea
• fast or irregular heartbeat
• dizziness/lightheadedness
• severe fatigue or weakness
It is important that you tell your healthcare providers that you have received BREYANZI and to show them your BREYANZI Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
Before getting BREYANZI, tell your healthcare provider about all your medical problems, including if you have or have had:
• Neurologic problems (such as seizures, stroke, or memory loss)
• Lung or breathing problems
• Heart problems
• Liver problems
• Kidney problems
• A recent or active infection
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive BREYANZI?
• BREYANZI is made from your own white blood cells, so your blood will be collected by a process called leukapheresis.
• It takes about 3-4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
• Before you get BREYANZI, you will get 3 days of chemotherapy to prepare your body.
• When your BREYANZI is ready, your healthcare provider will give it to you through a catheter placed into your vein. BREYANZI is given as infusions of 2 different cell types.
o You will receive infusions of one cell type, immediately followed by the other cell type.
o The time for infusion will vary, but will usually be less than 15 minutes for each of the 2 cell types.
• During the first week, you will be monitored daily by the facility where you received your treatment.
• You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting BREYANZI. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
• You may be hospitalized for side effects and your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
• Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
What should I avoid after receiving BREYANZI?
• Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get BREYANZI. This is because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, dizziness, and seizures.
• Do not donate blood, organs, tissues, or cells for transplantation.
What are the possible or reasonably likely side effects of BREYANZI?
The most common side effects of BREYANZI are:
• fatigue
• difficulty breathing
• fever (100.4°F/38°C or higher)
• chills/shaking chills
• confusion
• difficulty speaking or slurred speech
• severe nausea, vomiting, diarrhea
• headache
• dizziness/lightheadedness
• fast or irregular heartbeat
• swelling
BREYANZI can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.
BREYANZI can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.
BREYANZI may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.
Having BREYANZI in your blood may cause a false-positive HIV test result by some commercial tests.
These are not all the possible side effects of BREYANZI. Call your doctor for medical advice about side effects. For more information, go to BREYANZI.com or call 1-888-805-4555. You may report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information , including Boxed WARNINGS and Medication Guide.
Indication
BREYANZI is a prescription medicine used to treat large B cell lymphoma, a type of non-Hodgkin lymphoma, when:
• your first treatment has not worked or your cancer returned within a year of your first treatment OR
• your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age OR
• two or more kinds of treatment have not worked or stopped working
BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.
References:
1. What Is Non-Hodgkin Lymphoma? | Types of Non-Hodgkin Lymphoma. Accessed August 4, 2023.
https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html
2. Sawalha Y. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies. JPM. 2021;11(12):1345. doi:10.3390/jpm11121345
3. Kesireddy M, Lunning M. Relapsed or Refractory Diffuse Large B-Cell Lymphoma: “Dazed and Confused.” 2022;36:366-375. Accessed April 20, 2023. https://www.cancernetwork.com/view/journal-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-dazed-and-confused-.
4. Buechner J, Kersten MJ, Fuchs M, Salmon F, Jäger U. Chimeric Antigen Receptor-T Cell Therapy. Published online 2018. doi:https://doi.org/10.1097/hs9.0000000000000018
5. Zhang Y, Zhang Z. The history and advances in cancer immunotherapy: understanding the characteristics of tumor-infiltrating immune cells and their therapeutic implications. Cell Mol Immunol. 2020;17(8):807-821. doi:10.1038/s41423-020-0488-6
© Bristol Myers Squibb. 4/24. [2009-US-2400268]
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