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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 cell

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 Cell

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 Cell Multiply

CAR-T cells will multiply in your body so that you have even more cells seeking out and destroying cancer cells.

CAR-T Cell BCMA

CARVYKTI CAR-T cells are designed to find and attack BCMA, a protein found on the outside 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%.

ORR Percentage

Types of treatment response

ORR includes people with different kinds of responses. In the CARTITUDE-1 study:

  • 76 of 97 people (78%) experienced a stringent complete response (sCR)—the best possible response
  • 16 of 97 people (17%) 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:

1 Month Icon

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.

Twentyone months

Median duration of response was 21.8 months

Median duration of response (mDOR) among people who responded to treatment was 21.8 months at 18 months of median follow-up in the clinical trial. This means that in the CARTITUDE-1 study, half of the people treated kept responding to ciltacabtagene autoleucel for at least 21.8 months.

Median duration of response (mDOR) among people with stringent complete response (sCR) was not reached at 18 months of median follow-up. This means that more than half of people with sCR were still responding to treatment 18 months after being treated with ciltacabtagene autoleucel.

SEE THE FULL TREATMENT PROCESS

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

Ciltacabtagene autoleucel 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 light-headedness

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 neurologic toxicity. Your healthcare providers will monitor you for these side effects. CRS and neurologic toxicity 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 light-headedness
  • 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 toxicity. About half of these cases were serious or severe; three people died of neurologic toxicity.

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 927 days).

Other forms of neurologic toxicity that are distinct from ICANS may include parkinsonism, Guillain-Barré syndrome (GBS), 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 light-headedness
  • 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 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. 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.

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.

DOWNLOAD A GUIDE ON MONITORING POTENTIAL CARVYKTI SIDE EFFECTS WITH THE HELP OF YOUR HEALTHCARE TEAM