Carvykti for Multiple Myeloma
Carvykti (ciltacabtagene autoleucel) is a type of cancer immunotherapy known as chimeric antigen receptor (CAR) T-cell therapy, which works to help the body’s immune system find and attack cancer cells. When CAR T-cell therapy is given, a machine initially removes T cells (immune cells) from your blood, while the rest of your blood is infused back into your body. Your collected T cells are then sent to a laboratory, where they are genetically modified to attack cancer cells. Once the modified T cells are ready, people undergo chemotherapy infusions to prepare their body for the infusion of the CAR T-cell therapy.
What Kind of Cancer Does Carvykti Treat?
Multiple myeloma is a type of blood cancer that happens in the bone marrow (the soft, spongy tissue inside the bones). Carvykti reprograms your T cells (immune cells) to attach to a protein called BCMA that is found on the surface of the cancer cells. This can help your immune system recognize, attack, and kill the cancer cells.
How Will I Receive Carvykti?
Carvykti is given as an IV infusion once after you receive IV chemotherapy (cyclophosphamide and fludarabine) for three days. Carvykti is usually given two to four days after the chemotherapy infusion, and the infusion will always be given at a health care facility where a health care provider can monitor you for any side effects that can happen. You will be given other medicines within an hour before the start of the Carvykti infusion to minimize your risk of side effects.
How Was Carvykti Studied?
Two clinical studies looked at how effective Carvykti was for the treatment of multiple myeloma that had relapsed (come back) or was refractory (got worse) despite prior treatment. People in the studies knew what treatment they were getting and had to be relatively well-functioning with an Eastern Cooperative Oncology Group (ECOG) score of 1 or less (able to handle light activity).
CARTITUDE-4 study
The CARTITUDE-4 study included 419 adults who had received at least one prior therapy that included a proteasome inhibitor (bortezomib, carfilzomib, ixazomib) and an immunomodulatory agent (lenalidomide, pomalidomide). People were assigned to either standard treatment or standard treatment plus chemotherapy, then Carvytki. Standard treatment was made up of either daratumumab, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone.
People were 27-80 years old. Over half (57%) of the study participants were male; 75% were White, 3% were Black or African American, 9% were Asian, and 13% were of another race or not reported. Most (85%) had received a prior stem cell transplant.
People were not allowed in the study if their cancer currently or previously involved the brain or if they had a history of Parkinson’s disease or other condition that involved the nervous system.
CARTITUDE-1 study
In CARTITUDE-1, which included 97 adults, people had to have received at least three prior treatments that included a proteasome inhibitor (bortezomib, carfilzomib , ixazomib), an immunomodulatory agent (lenalidomide, pomalidomide), and an anti-CD38 monoclonal antibody (daratumumab).
People ranged in age from 56 to 68. About half (59%) were male; 71% were White, 18% were Black, 1% each were Asian, American Indian or Alaskan native, Native Hawaiian, or other Pacific Islander, and 8% had an ethnicity that was not reported. People received 3-18 prior lines of therapy, and all but two people had received a prior stem cell transplant.
People were not allowed in the study if they had any of the following.
- Myeloma currently or previously involved the brain
- Plasma cell leukemia
- Recent allogeneic (donor) stem cell transplant
- Poor kidney function
- Laboratory parameters or heart failure that did not meet certain criteria
- Serious infection
What Benefits Were Seen With Carvykti?
CARTITUDE-4 study
Almost 76% of people who received Carvykti had cancer that did not progress (get worse) at 12 months compared to about 49% of people who received standard therapy. Additionally, at a median (middle) follow-up of 15.9 months, 74% of people who received Carvykti had a complete or better (less than 5% plasma cells in bone marrow) response compared to about 22% who received standard therapy.
CARTITUDE-1 study
After a median follow-up of 28 months, 95 of the 97 people had a response ranging from a stringent complete response (no detectable cancer) to a partial response (decrease in cancer).
One-third of people who received Carvykti remained alive without their cancer getting worse after five years.
Your results may differ from what was seen in clinical studies.
What Are the Possible Side Effects of Carvykti, and How Can I Prevent or Manage Them?
Carvykti may cause serious or life-threatening side effects, such as cytokine release syndrome (CRS) or problems with your nervous system (neurological problems). The sudden release of immune substances called cytokines in the blood is called CRS. In clinical studies, CRS happened at a median of seven days (range, 1-23 days) after Carvykti. Over 75% of people in clinical studies had CRS. Life-threatening problems with your nervous system can happen days, weeks, or months after getting Carvykti.
CRS. Symptoms include a fever (100.4 F or higher), chills, tiredness, headache, a fast heartbeat, low blood pressure, dizziness or light-headedness, and trouble breathing.
Immune effector cell-associated neurotoxicity syndrome (ICANS). Symptoms include headaches, muscle jerks or spasms, feeling restless, less alert, or disoriented, numbness and tingling (feeling like “pins and needles”), confusion, trouble speaking, shaking (tremor), double vision, changes in your handwriting, problems walking, muscle weakness in your body or face, hearing loss, and burning, throbbing, or stabbing pain.
Parkinsonism. Symptoms include slow or rigid movement, shaking that you cannot control (tremors), muscle stiffness, shuffling when walking, stooped posture, tiredness, issues with memory, attention, or decision-making, and changes in personality, such as being less talkative or reduced ability to express emotions.
Guillain-Barré syndrome (GBS). Symptoms include tingling or numbness in your feet and hands that spreads to other areas of the body. You may have muscle weakness or paralysis.
Peripheral neuropathy. Symptoms include numbness, burning, or tingling in the hands, feet, or legs and burning or shooting pain.
Cranial nerve palsies, such as sixth nerve palsy. Symptoms may cause facial paralysis (weakness or loss of movement) or numbness.
Get emergency medical help if you have any symptoms of either CRS or neurological problems. When you get emergency help, be sure to tell the health care provider that you got Carvykti and show your Carvykti patient wallet card.
Other side effects
Carvyki may cause low levels of one or more types of blood cells, which can make you feel weak or tired or increase your risk of infection. Avoid being around people who are sick, and stay away from crowded places, especially during the cold and flu season. Wear a well-fitting mask in busy areas for added safety. Tell your health care provider if you have a fever, chills, cough, difficulty breathing or chest pain, sore throat, pain while peeing, or unusual bleeding or bruising or if you generally feel weak or unwell. Keep all appointments to have your blood checked.
Carvykti can also increase your risk of developing certain types of cancers, including blood cancers. Your health care provider will monitor you for the development of other cancers.
These are not all the possible side effects of Carvykti. Contact your health care provider for medical advice about side effects. You can report side effects to the FDA at 800-FDA-1088 (800-332-1088) or www.fda.gov/medwatch. You can also report side effects to the drugmaker, Janssen Biotech, at 800-526-7736.
What Are Other Unique Considerations to Be Aware Of?
Carvykti can only be given at certified treatment centers where health care providers are specially trained to give the medicine. You can find the treatment center closest to you at carvykti.com/treatment-centers/.
People who receive Carvykti must be monitored every day for the first week after the infusion and must also stay close to a health care facility for at least two weeks after the infusion. If a life-threatening reaction occurs, you need to be close to a health care facility so you can receive medical help soon.
Do not drive for at least two weeks after getting Carvykti. This is because of side effects that can develop after the infusion, which could put you at risk for an accident while you are driving.
People should avoid receiving certain types of vaccines called live vaccines for at least six weeks before Carvytki treatment and until their immune system has recovered after treatment. Check with your health care provider before getting any vaccines.
Before you receive Carvykti, your health care provider will make sure you are not pregnant. If you would like to get pregnant after getting Carvykti, talk with your health care provider.
Is There Any Cost Assistance Available?
There is a cost support program from the drugmaker that assists with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses when you get treatment at a certified treatment center. You can find out more at carvykti.com/resources-and-support/#myCarvyktiPatientSupportProgram or by calling 800-559-7875.
