HOW CARVYKTI® WORKS
CARVYKTI® helps your immune system fight multiple myeloma
CARVYKTI® is different than other commonly used cancer therapies (such as chemotherapy) because it is made from your own white blood cells, which have been changed (genetically modified) to recognize and attack your multiple myeloma cells.
HOW CARVYKTI® WORKS
T cells are a type of immune cell that patrol the body for signs of infection and disease, and then start a response to attack them. But sometimes cancer cells are structured in a way that prevents T cells from recognizing or attacking them.
CAR-T therapy works by collecting your body's own T cells and genetically modifying them to create personalized CAR-T cells that will recognize and fight your cancer. Your CAR-T cells are then returned to your body in a one-time infusion.
CAR-T cells will multiply in your body so that you have even more cells seeking out and destroying cancer cells.
CARVYKTI® CAR-T cells are designed to find and attack BCMA, a protein found on the surface of nearly all multiple myeloma cells as well as on normal plasma cells. BCMA is over-expressed on multiple myeloma cells.
BCMA=B cell maturation antigen; CAR-T=chimeric antigen receptor-T cell.
PATIENT RESPONSE IN A CLINICAL STUDY
Ciltacabtagene autoleucel is a treatment administered in a one-time infusion that was studied in CARTITUDE-1, a clinical study of 97 adults with relapsed or refractory multiple myeloma. In the clinical study, most patients had received at least four treatment regimens, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody before their symptoms returned or their disease stopped responding to treatment.
Overall response rate (ORR)
ORR is the percentage of people who have any kind of response after treatment with ciltacabtagene autoleucel. In the CARTITUDE-1 study, 95 of 97 patients responded to ciltacabtagene autoleucel, for an ORR of 98%.
Types of treatment response
ORR includes people with different kinds of responses. In the CARTITUDE-1 study:
- 78 of 97 people (80%) experienced a stringent complete response (sCR)—the best possible response
- 14 of 97 people (14%) experienced a very good partial response (VGPR)
- 3 of 97 people (3%) experienced a partial response (PR)
Talk to your doctor for more information about the types of responses.
CD38=cluster of differentiation 38.
In a clinical trial, following a one-time infusion, people experienced the following responses:
Median time to first response was 1 month
In the CARTITUDE-1 study, some people responded to ciltacabtagene autoleucel as soon as 0.9 months after infusion, and some as late as 10.7 months. The median, or amount of time where half responded sooner and half responded later, was 1 month.
Median duration of response was not reached
Median duration of response (mDOR) among people who responded to treatment was not reached at 28 months of median follow-up in the clinical trial.
Median duration of response (mDOR) among people with stringent complete response (sCR) was not reached at 28 months of median follow-up.
WHO IS CARVYKTI® FOR?
CARVYKTI® is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used after you’ve received at least four other treatment regimens and your multiple myeloma has come back or has stopped responding to treatment. Your doctor will be able to assess whether you're eligible for treatment with CARVYKTI®.
Prior treatment requirements for CARVYKTI®
To be eligible for treatment with CARVYKTI®, you'll need to have been treated with at least four other kinds of treatment regimens, including at least one therapy from each of these drug classes: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
SAFETY PROFILE
CARVYKTI® may cause side effects that are severe or life-threatening and can lead to death.
Call your healthcare provider or get emergency help right away if you experience any of the following:
- Fever (100.4°F or 38°C or higher)
- Chills or shaking chills
- Fast or irregular heartbeat
- Difficulty breathing
- Very low blood pressure
- Dizziness or lightheadedness
Call your healthcare providers or get emergency help right away if you experience effects on your nervous system, some of which can occur days or weeks after you receive your infusion, and may initially be subtle, such as:
- Feeling confused, less alert, or disoriented
- Difficulty speaking or slurred speech
- Difficulty reading, writing, and understanding words
- Memory loss
- Loss of coordination affecting movement and balance
- Slower movements
- Changes in handwriting
- Personality changes including reduced ability to express emotions, being less talkative, disinterested in activities, and reduced facial expression
- Tingling, numbness, and pain of hands and feet
- Difficulty walking, leg and/or arm weakness
- Difficulty breathing
- Facial numbness, difficulty moving face and eye muscles
These are not the only side effects you should be aware of while on treatment with ciltacabtagene autoleucel. For more information, please see the Medication Guide for CARVYKTI® or talk to your healthcare providers.
Two of the most common serious side effects people experience are cytokine release syndrome (CRS) and neurotoxicity. Your healthcare providers will monitor you for these side effects. CRS and neurotoxicity are serious side effects, and need to be identified and treated quickly.
Cytokine release syndrome (CRS)
CRS, including fatal or life-threatening reactions, occurred after ciltacabtagene autoleucel infusion.
CARVYKTI® can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. CRS occurs when your immune system becomes overly active. This is caused by the treatment and its effect on the immune cells.
This is why it’s important to share any changes in how you’re feeling with your healthcare providers, regardless of how small they may seem. The members of your healthcare team are experts trained to manage CRS and they’re ready to support you.
In the CARTITUDE-1 study, the majority of patients (95%) experienced CRS. On average, CRS set in 7 days after infusion and lasted a median of 4 days (range was 1 to 40 days).
Signs and symptoms of CRS may include:
- Fever
- Difficulty breathing
- Dizziness or lightheadedness
- Nausea
- Headache
- Fast heartbeat
- Low blood pressure
- Fatigue
Neurologic side effects
Neurologic toxicity side effects can be a life-threatening or even fatal condition where your central nervous system reacts to the infusion.
CARVYKTI® can cause various neurologic side effects, some of which may be severe or fatal. In the CARTITUDE-1 study, 25 people (26%) experienced neurologic toxicities. About half of these cases were serious or severe.
Some of these neurologic toxicity side effects can be signs of a serious immune reaction associated with CAR-T therapy called immune effector cell-associated neurotoxicity syndrome, or ICANS. In the CARTITUDE-1 study, 22 people (23%) experienced ICANS. All of these people previously had CRS. Of these 22 cases, 5 were severe and 2 were fatal. The remainder (17 cases) were mild to moderate. The median time to onset of ICANS was 8 days (range, 1 to 28 days). The median duration of ICANS was 7.5 days (range, 2 to 1,229 days).
Other forms of neurologic toxicity that are distinct from ICANS may include parkinsonism, Guillain-Barré syndrome (GBS), immune mediated myelitis, peripheral neuropathy, and cranial nerve palsies. Some people treated with ciltacabtagene autoleucel in clinical studies have experienced these other forms of neurologic toxicity. In a separate, ongoing study of ciltacabtagene autoleucel, one person died after developing GBS. Your healthcare provider will monitor for GBS and provide care as needed.
Signs or symptoms associated with neurologic toxicity, some of which may occur days or weeks following the infusion, may include:
- Confusion
- Disorientation
- Loss of consciousness
- Seizures
- Difficulty speaking, reading, or writing
- Tremor
- Slower movements
- Changes in personality
- Depression
- Tingling and numbness of hands and feet
- Leg and arm weakness
- Facial numbness
Neurologic toxicity is a serious side effect, and needs to be identified and treated quickly.
These are not all the possible side effects of CARVYKTI®. Tell your healthcare providers immediately if you experience any side effects.
COMMON SIDE EFFECTS
The most common side effects of CARVYKTI® include:
- Fever (100.4°F/38°C or higher), chills
- Dizziness or lightheadedness
- Headache, muscle or joint pain, feeling very tired
- Altered mental state, confusion
- Infections
- Low levels of antibodies (immunoglobulins) in the blood
- Cough, being short of breath
- Diarrhea, nausea, decreased appetite, constipation
- Fast or irregular heartbeat
- Problems with blood clotting
OTHER POSSIBLE SIDE EFFECTS
CARVYKTI® can increase the risk of life-threatening infections including COVID-19 that may lead to death. Tell your healthcare providers right away if you develop fever, chills, or any signs or symptoms of an infection.
CARVYKTI® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]) which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare providers will test your blood to check for this. Tell your healthcare providers right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.
CARVYKTI® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]) which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare providers will test your blood to check for this. Tell your healthcare providers right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.
CARVYKTI® can increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.
Having CARVYKTI® in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.
These are not all the possible side effects of CARVYKTI®. Tell your healthcare providers immediately if you experience any side effects.
THE CARVYKTI® REMS PROGRAM
What is the CARVYKTI® REMS Program?
A Risk Evaluation and Mitigation Strategy (REMS) program is a drug safety program that the US Food and Drug Administration (FDA) requires for certain medicines with serious safety concerns. Drug companies and healthcare professionals must take extra steps to make sure the benefits of using the drug are more than the risks. The FDA must approve these steps as part of a REMS program.
Due to the risk of serious side effects such as cytokine release syndrome (CRS) and neurotoxicity, which can be life-threatening and can lead to death, CARVYKTI® can only be administered at healthcare settings certified in the CARVYKTI® REMS Program.
As part of the CARVYKTI® REMS Program, you will be given a CARVYKTI® Patient Wallet Card either before or at the time of receiving your CARVYKTI® infusion. Work with your healthcare providers to fill out the card, and be sure to carry your completed CARVYKTI® Patient Wallet Card with you at all times. For more information about the CARVYKTI® REMS Program or to download a replacement card if needed, visit www.CARVYKTIrems.com.
MONITORING FOR SIDE EFFECTS
After your infusion of CARVYKTI®, your healthcare providers at the CARVYKTI® Certified Treatment Center will closely monitor you daily for 10 days following infusion for any signs and symptoms of a reaction to treatment.
You should plan to stay close to the location where you received your treatment for at least 4 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
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. After this 4 week monitoring period, your healthcare providers will continue to provide care and partner with you to create a plan for long-term monitoring and regular follow-ups. Let your healthcare providers know if you're not feeling well. Do not drive, or operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you receive CARVYKTI®. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects as discussed by your healthcare provider.
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