Tecvayli (teclistamab-cqyv) is a prescription injection medicine for people with a type of blood cancer called multiple myeloma, whose cancer has come back (relapsed) or worsened (refractory) after trying at least four different lines of treatment. Previous treatments must include specific medicines that boost the immune system or help kill the cancer cells. The FDA approved Tecvayli in 2022 for adults with this condition. It is injected under the skin once every week or every two weeks by a doctor who has been specially trained to prescribe and inject Tecvayli.
How Does Tecvayli Work in Multiple Myeloma?
Multiple myeloma is a type of blood cancer that happens in the bone marrow (the soft, spongy tissue inside the bones). Tecvayli attaches to a protein called BCMA that is found on the surface of the cancer cells. This may help the immune system recognize, attack, and kill the cancer cells.
Is Tecvayli Right for Me?
Tecvayli may be the right choice for you if you:
- Are an adult with relapsed or refractory multiple myeloma
- Have tried at least four previous lines of treatments for multiple myeloma, including:
- Immune system modulators (help boost the immune system to fight cancer)
- Proteasome inhibitors (make it harder for the cancer cells to grow and survive)
- Anti-CD38 antibodies (help the immune system kill cancer cells)
Your health care provider will review your medical history and decide if Tecvayli is right for you.
How Was Tecvayli Studied for Treating Multiple Myeloma?
One clinical study, the MajesTEC-1 trial, was done to look at the benefits and risks of Tecvayli in people with relapsed or refractory multiple myeloma.
The focus of this study was to find out how well Tecvayli worked to manage cancer.
To learn this, the researchers looked at the number of people whose cancer shrank (partial response) or disappeared completely (complete response) after getting Tecvayli. This is called overall response rate (ORR).
Researchers also looked at how long the people in the study lived without their cancer worsening. This is called progression-free survival (PFS).
What medicines did the people in the study take?
People in the study got Tecvayli as a weekly injection under the skin. The amount of medicine each person got was based on how much they weighed. The dose started small and was slowly increased to 1.5 milligrams of Tecvayli per kilogram of body weight (1.5 mg/kg).
Who was included in the study?
People in the study met the following requirements:
- Age 18 years or older
- Relapsed or refractory multiple myeloma that was progressing
- Previously received at least three lines of cancer treatment: a proteasome inhibitor, an immune system modulator, and an anti-CD38 antibody
- A score of 0 or 1 on a system called the Eastern Cooperative Oncology Group scale (ECOG), which measures how people can take care of themselves, do their daily activities, and move around. The ECOG score goes from 0 to 5. Higher scores show more challenges with these tasks.
Who was excluded from the study?
People could not be in this study if they had:
- Previous treatments that worked in a similar way to Tecvayli
- Certain recent cancer treatments.
- Side effects from past cancer treatments that were still causing problems
- Signs of multiple myeloma affecting their brain and nervous system
- An ECOG score of 2 or higher
What was the study population?
- A total of 165 people in the study got Tecvayli.
- The average age of these people was 64 years (range of 33-84 years).
- About 58% of them were male and 42% were female.
- About 81% of them were White, 13% Black, 2% Asian, and about 4% belonged to other racial or ethnic groups.
- About 33% had an ECOG score of 0, and about 67% had a score of 1.
- All had an average of five previous lines of cancer treatment.
- About 53% had stage I, about 35% had stage II , and about 12% had stage III multiple myeloma.
How long was the study?
People continued getting Tecvayli until their cancer got worse, they had serious side effects, they chose to stop, they passed away, or the study ended (which was two years after the last person in the study got their first dose).
What Were the Main Benefits of Tecvayli Seen in the Study?
Some people did not stay in the study long enough or did not meet the rules for measuring how well Tecvayli worked. So researchers looked at the main results from 110 people out of the 165 who enrolled in the study.
Among these 110 people:
- About 62% showed some improvement after getting Tecvayli (ORR).
- About 28% showed a complete response.
- About 29% showed a very good partial response.
- About 5% showed a partial response.
- The time it took for cancer to improve was between about six days (0.2 months) to about 5.5 months. About half of the people saw results within about five weeks (1.2 months).
- The researchers followed up with the people who saw results, for an average of about 32 weeks (7.4 months).
- About 91% stayed in the study for at least six months.
- About 67% stayed in the study for at least nine months.
Progression-free survival: Cancer did not worsen for about 11 months in half of the 165 people in the study.
What Are the Possible Side Effects of Tecvayli, and How Can I Prevent or Manage Them?
Tecvayli may cause serious or life-threatening side effects because of how it affects the immune system. These side effects happen after a sudden release of immune substances called cytokines in the body.
Cytokine release syndrome
The sudden release of cytokines in the blood is called cytokine release syndrome (CRS). The symptoms of CRS include a fever (100.4 F or higher), chills, dizziness, a fast heartbeat, trouble breathing, a headache, higher blood levels of liver enzymes, and feeling anxious, confused, or restless. In the clinical trial, CRS mostly happened after the first doses. In half of the people who had CRS, it happened within two days after getting a dose, while in others, it happened within one to six days. CRS was mild in half of the people in the study.
Neurologic problems
High levels of cytokines in the fluid around the brain and the spinal cord can cause a condition called ICANS, which affects the brain and nerves. The symptoms of ICANS include headaches, muscle jerks or spasms, feeling restless, 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. ICANS can happen at the same time that CRS does or a few days after.
Call your health care provider right away if you notice any of the signs or symptoms of CRS or neurologic problems at any time during your treatment with Tecvayli.
Liver problems
Tecvayli can cause serious liver problems. Your health care provider will regularly test you for any issues while you are getting Tecvayli. Make sure to tell them if you feel tired all the time, don’t have an appetite, have nausea and vomiting that won’t go away, have stomach pain, have dark urine, or notice yellowing of your skin or the whites of your eyes.
Other common side effects of Tecvayli are infections and low levels of white blood cells. 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, or a cough that won’t go away.
These are not all the possible side effects of Tecvayli. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. 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.
How Do I Know if Tecvayli Is Working?
Your health care provider will regularly check how well Tecvayli is working by ordering lab tests to check for multiple myeloma proteins in your blood. They may also assess your ECOG score to evaluate your overall health status. And they may order imaging tests such as X-rays, MRI scans, and CT scans, or perform bone marrow biopsies to take samples for examination.
Do not stop your Tecvayli injections or change your injection schedule unless your health care provider tells you to. Your health care provider will do regular physical and neurological examinations and order lab tests to check for side effects. They will change your treatment plan if needed.
How Do Other Medicines Interact With Tecvayli?
Tell your pharmacist and other health care providers about all the other prescription and nonprescription medicines, vitamins, supplements, and herbal products you take before starting Tecvayli and while you are getting it.
Tecvayli may affect how other medicines work in your body. The cytokines that are released after you take Tecvayli can interfere with a protein called CYP that helps break down some medicines. This can lead to higher levels of these medicines in your body, which may be harmful. Your health care provider will keep an eye on how Tecvayli affects these medicines and adjust their doses, if needed.
Examples of medicines that Tecvayli may affect are cyclosporine (used in organ transplants), midazolam (a medicine for sleep and anxiety), omeprazole (a stomach acid reducer), simvastatin (a cholesterol reducer), and warfarin (a blood thinner).
How Can I Get Tecvayli?
You will need a prescription from a doctor who specializes in cancer treatment (an oncologist). Your oncologist will arrange for you to get your injections at a special clinic where the staff is trained to give Tecvayli.
If you need help paying for Tecvayli, the drugmaker may be able to assist you. Check out their ‘J&J withMe” Support Program at https://www.tecvayli.com/savings-support/ to learn more about getting help with costs, your insurance coverage, and how to get your Tecvayli injections. You can also contact the drugmaker at 833-565-9631.
