What to Know About Carvykti for Multiple Myeloma

Multiple myeloma is a blood cancer that affects the lives of over 150,000 people across the country. It doesn't have a cure, but many new treatments have been approved in recent years. And they have made treating multiple myeloma and its symptoms more possible. This includes options such as immunotherapy and targeted therapies.

Even though progress has been made, cancer specialists still aren't satisfied. To help further improve the quality and length of life for those living with multiple myeloma, many organizations are looking to develop new-and-improved treatments to fight this form of blood cancer more effectively.

One example of this research is chimeric antigen receptor (CAR) T-cell therapy. It's a type of immunotherapy that uses your own immune cells to fight cancer. Carvykti was FDA approved in February 2022 as the second CAR T-cell therapy for multiple myeloma.

Here, we'll discuss next how Carvykti works, how effective it is, and possible side effects it can cause.

What is Carvykti?

Carvykti (ciltacabtagene autoleucel) is an immunotherapy medication that treats multiple myeloma. Multiple myeloma affects plasma cells - a type of white blood cell - that come from your bone marrow.

Carvykti is also a type of gene therapy. This is because it's made from your own white blood cells - specifically your T cells - that have been modified to fight multiple myeloma cancer cells more effectively. T cells are a type of white blood cell in your immune system that fight foreign invaders such as bacteria, viruses, and cancer cells.

While Carvykti is relatively new and enticing, it's not a first-choice option. It's usually only considered after at least one other treatment hasn't worked or has stopped working. This includes having tried a more standard medication, such as Revlimid (lenalidomide) or Velcade (bortezomib).

How does Carvykti work for multiple myeloma?

Some cancer cells can hide from your immune system. Caryvkti works by helping your own immune cells find and attack these cancer cells.

More specifically, your T cells are reprogrammed, or genetically modified, so they express CAR proteins. When T cells have CAR proteins on them, they're better at recognizing specific targets on cancer cells and getting rid of them. These targets are called B-cell maturation antigen (BCMA). Multiple myeloma cells tend to have a lot of BCMA proteins on their surfaces.

By targeting BCMA on cancer cells, Carvykti helps your immune system work better to fight multiple myeloma.

What does the CAR T-cell process look like?

Carvykti is made from your own white blood cells. To get the process underway, your blood is collected in a process called leukapheresis. Leukapheresis can take about 3 to 6 hours to complete.

Next, your white blood cells are sent to a lab to create your Carvykti dose. It can take about 4 to 5 weeks to make your dose. Once it's made, it's sent back to your healthcare team so they can give it to you via an infusion.

After getting Carvykti, you'll be monitored at the healthcare facility where you received your treatment. You should plan to stay close to the location where you received your treatment for at least 4 weeks.

How is Carvykti given when treating multiple myeloma?

Carvykti is a one-time medication that's infused into one of your veins. It usually takes about 30 minutes to infuse into your body. But before you get Carvykti, there are a number of steps to keep in mind.

For instance, you'll receive low-dose chemotherapy for 3 days. This usually includes two chemotherapy medications - cyclophosphamide and fludarabine. This is done to help prepare your immune system for the Carvykti infusion. To prevent infusion reactions, you'll also receive medications like acetaminophen (Tylenol) and diphenhydramine (Benadryl) before your infusion starts.

How effective is Carvykti when treating multiple myeloma?

Carvykti was included in a study of over 400 adults with relapsed or refractory multiple myeloma. Relapsed multiple myeloma means the cancer has returned after initially getting better. Refractory means that the previous cancer treatment stopped working.

In the study, Carvykti lowered the risk of death or disease progression by roughly 70% compared to chemotherapy, which is a common treatment for this condition.

Carvykti's manufacturers also released newer data for the medication in mid 2024. The data demonstrated an overall survival benefit in people who received Carvykti as early as their second multiple myeloma treatment. Meaning, people with relapsed or refractory multiple myeloma who received Carvykti as early as their second treatment lived longer than those who received standard-of-care chemotherapy.

What are the possible side effects of Carvykti?

Carvykti commonly causes a side effect called cytokine release syndrome (CRS). It's a type of intense inflammatory response. Common CRS side effects include fever, low blood pressure, high heart rate, and more. Symptoms can range from mild to severe. More severe CRS symptoms are discussed below.

Aside from CRS, many other Carvykti side effects are also common. They include:

• Muscle or joint pain

• Fatigue

• Cough

• Chills

• Diarrhea

• Constipation

• Nausea and vomiting

• Headache

• Dizziness

• Shortness of breath

• Swelling caused by fluid buildup

Serious side effects

Carvykti has a few boxed warnings. This is the most serious type of warning that the FDA can give to a medication.

CRS, and its related issues, have boxed warnings. CRS can be serious. And it can overlap with a condition called hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS). This syndrome can happen when the immune system overreacts and attacks normal cells. Signs and symptoms include:

• Low blood pressure

• Low oxygen levels

• Multiple organ dysfunction

• Kidney problems

• Low blood counts

• Bleeding disorders

Carvykti also has a boxed warning for neurotoxicities - more specifically a condition called immune effector cell-associated neurotoxicity syndrome (ICANS). ICANS can occur with or without CRS. Possible symptoms of these brain and nerve-related problems include:

• Encephalopathy, including memory loss and confusion

• Tremor

• Trouble speaking

• Seizures

Carvykti has other boxed warnings for Parkinsonism, Guillain-Barré syndrome, and extended or chronic episodes of low blood cell counts (with bleeding and infection).

These side effects can be life-threatening if not managed quickly and appropriately. For this reason, you and your cancer specialist should closely watch your health for at least 4 weeks after your infusion. And you'll need to stay close to your healthcare facility. You also shouldn't drive or do tasks that need mental alertness for 8 weeks after your infusion.

Due to these severe side effects, healthcare facilities administering Carvykti must be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) medication safety program.

How to save on Carvykti

There are ways to save on Carvykti, which is only available as a brand-name medication. GoodRx can help you navigate patient assistance programs to save money on your prescription. Your oncology care team can also direct you to savings opportunities.

Certain people are eligible for Carvykti's manufacturer-sponsored patient assistance program, which walks you through financial resourcing and medication access options. This includes savings on travel-related expenses if you need to travel to a certified treatment center. Call 1-800-559-7875 for more information.

What are some alternatives to Carvykti?

If you have relapsed or refractory multiple myeloma, know that other treatment options are available in addition to Carvykti.

One similar option is Abecma (idecabtagene vicleucel). It was the first CAR T-cell therapy approved for relapsed/refractory multiple myeloma.

Many other medications are also available that aren't CAR T-cell therapies. A few examples are Tecvayli (teclistamab) and Talvey (talquetamab). They're antibodies that work by bringing your T-cells and multiple myeloma cells together. This allows your immune system to better attack myeloma cancer cells and slow cancer growth.

Your cancer specialist can tell you if Abecma, Carvykti, or another medication may be a treatment option for you.