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 other treatments. Previous treatments must include specific medicines that boost the immune system and help kill the cancer cells. Tecvayli can be used alone or in combination with a medicine called daratumumab/hyaluronidase-fihj.
The FDA approved Tecvayli in 2022. It is injected under the skin 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 certain cells, including 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
- When used alone, you must have tried at least four previous types 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)
- When used with daratumumab/hyaluronidase-fihj, you must have tried an immune system modulator and a proteasome inhibitor.
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?
Two clinical studies, the MajesTEC-1 and MajesTEC-3 trials, were done to look at the benefits and risks of Tecvayli in people with relapsed or refractory multiple myeloma.
The focus of these studies was to find out how well Tecvayli worked to manage cancer.
To learn this, the researchers looked at the number of people whose cancer improved (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 MajesTEC-1 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).
People in MajesTEC-3 got daratumumab/hyaluronidase-fihj (Darzalex Faspro), which is another medicine used to treat multiple myeloma, along with Tecvayli according to the following schedule.
- 1.5 mg/kg/week for the first 8 weeks
- 3 mg/kg every other week for 12 weeks
- 3 mg/kg every 4 weeks for the remainder of the study
Who was included in the study?
The table below describes the requirements for entry into the studies.
MajesTEC-1 | MajesTEC-3 | |
| Age | 18 years or older | |
| Type of Multiple Myeloma | Relapsed or refractory multiple myeloma that was progressing | |
| Previous Treatments | At least 3 lines of cancer treatment: a proteasome inhibitor, an immune system modulator, and an anti-CD38 antibody | 1 to 3 lines of cancer treatment: a proteasome inhibitor and lenalidomide |
| ECOG* Score | 0 or 1 | 0, 1, or 2 |
*Eastern Cooperative Oncology Group (ECOG) scale measures how well 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.
People could not join the studies if they had previous treatments that worked in a similar way to Tecvayli or received a live vaccine in the last 4 weeks.
What were the study participants like?
The chart below summarizes characteristics of the people enrolled in the studies of Tecvayli.
MajesTEC-1 Tecvayli alone | MajesTEC-3 Tecvayli plus daratumumab/hyaluronidase-fihj | |
| Number of people who got Tecvayli | 165 | 291 |
| Average age | 64 years old (range of 33 to 84 years) | 64 years old (range of 25 to 88 years) |
| Sex | Male (58%) Female (42%) | Male (55%) Female (45%) |
| Race/Ethnicity | White (81%) Black (13%) Asian (2%) Other (4%) | White (65%) Black (6%) Asian (22%) Other (7%) |
| ECOG scores | 0 (33%) 1 (67%) | 0 (56%) 1 (40%) 2 (4%) |
| Number of previous treatments for multiple myeloma | Median of 5 Range: 2 to 14 | Median (middle): 2 Range: 1 to 3 |
| Cancer stages | Stage 1 (53%) Stage 2 (35%) Stage 3 (12%) | Stage 1 (62.5%) Stage 2 (29.5%) Stage 3 (8%) |
How long were the studies?
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.
What Were the Main Benefits of Tecvayli Seen in the Studies?
Tecvayli, when used alone or especially when used in combination with daratumumab/hyaluronidase-fihj, seems to improve progression-free survival in people with multiple myeloma. See the details in the results table below.
MajesTEC-1 Tecvayli alone 110 people* | MajesTEC-3 Tecvayli plus daratumumab/hyaluronidase-fihj 291 people | |
| Improvement with Tecvayli | Overall response (ORR): ~62% Complete response: ~28% Very good partial response: ~29% Partial response: 5% | Overall response (ORR): 89% Complete response: 81.8% Very good partial response: 4.8% Partial response: 2.4% |
| Time to improvement | Ranged from 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) | Time to first response: about 1.2 months
Time to complete response: about 6.9 months |
| Progression-free survival (PFS) | Median (middle) PFS: 11.3 months | 36-month PFS: 83.4% |
*Note that 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.
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 this website 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.
