Tecvayli (teclistamab-cqyv) for multiple myeloma
Fact-checked by What is Tecvayli for multiple myeloma?
Tecvayli (teclistamab-cqyv) is an approved antibody-based therapy for certain heavily pretreated adults with multiple myeloma that has returned after prior therapies (relapsed) or proven resistant to treatment (refractory). The therapy’s approval in the U.S. and the European Union is provisional, meaning that additional evidence of the medication’s effectiveness is required for its full continued approval.
Multiple myeloma occurs when plasma cells, a type of immune cell, become cancerous and start growing out of control in the bone marrow, the spongy interior of some bones where blood cells are produced.
Tecvayli aims to help the immune system more efficiently target and kill cancerous plasma cells (myeloma cells). It is a bispecific antibody that simultaneously recognizes and binds to two proteins. One of those proteins is CD3, which is found on the surface of immune T-cells, and the other is B-cell maturation antigen, which is found on the surface of plasma cells, including myeloma cells. This dual binding activates T-cells, which can kill cancer cells, and directly connects them to the myeloma cells they need to destroy. In some patients, this can help control multiple myeloma.
Johnson & Johnson (J&J) is developing and selling Tecvayli, which is administered via under-the-skin (subcutaneous) injections. The company is currently sponsoring clinical trials that, if successful, may support Tecvayli’s transition to full approval.
Therapy snapshot
| Brand name | Tecvayli |
| Chemical name | Teclistamab-cqyv |
| Usage | Used to treat certain adults with relapsed or refractory multiple myeloma |
| Administration | Subcutaneous injection |
Who can take Tecvayli?
In the U.S., Tecvayli is approved under accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have previously received at least four lines of treatment, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
The therapy’s conditional approval in the EU is for a similar indication.
There are no listed contraindications or reasons to avoid using Tecvayli. However, the therapy’s prescribing information comes with a boxed warning for potentially life-threatening complications, including inflammatory responses and neurological conditions. For this reason, Tecvayli is only available in the U.S. through a restricted distribution program called the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy.
How is Tecvayli administered?
A healthcare professional administers Tecvayli in a hospital setting as a subcutaneous injection. Usually, the injection is given into the abdomen, but it can also be given into the thigh or other parts of the body.
Patients starting Tecvayli usually follow a step-up dosing schedule featuring three increasing doses over one week, with the third dose being the first full dose (1.5 mg/kg). After each injection, patients typically stay in the hospital for two days to allow doctors to monitor them for signs of serious side effects.
After the step-up period, treatment is usually given once weekly until disease progression or unacceptable toxicity. If patients respond to treatment (achieve a complete response or better) and continue responding for at least six months, dosing frequency may be reduced to once every two weeks until disease progression or unacceptable toxicity.
Tecvayli in clinical trials
Tecvayli’s accelerated approval in the U.S. was supported by data from the MajesTEC-1 clinical trial, which included a Phase 1/2 portion (NCT03145181) to establish the therapy’s recommended dose, and a Phase 2 portion (NCT04557098) to assess the safety and efficacy of that dose in a larger patient population. The study included RRMM patients who had previously received at least three lines of therapy.
- The Phase 1/2 portion of the study established a dose of 1.5 mg/kg after the step-up period, which is now the approved full dose, for the Phase 2 portion.
- Among the subset of 110 patients who comprised the study’s Phase 2 efficacy population, approximately 62% had at least a partial response to treatment. Follow-up data showed that treatment responses were maintained in the long term.
Several ongoing studies have suggested that Tecvayli is effective in different RRMM settings, including:
- RedirecTT-1 (NCT04586426), a Phase 1/2 trial that is testing Tecvayli in combination with Talvey (talquetamab-tgvs), another bispecific antibody therapy. After a year of treatment, most participants were alive and free from disease progression.
- MajesTEC-3 (NCT05083169), a Phase 3 trial that showed the combination of Tecvayli and Darzalex Faspro (daratumumab and hyaluronidase-fihj), another approved myeloma treatment, significantly extended the time patients lived without disease progression compared with standard-of-care regimens. Based on these findings, J&J is seeking approval of this treatment combination in the U.S. and EU.
- MajesTEC-9 (NCT05572515), a Phase 3 trial that showed Tecvayli surpassed standard-of-care combination regimens in its ability to delay disease progression and extend survival in previously treated patients.
Tecvayli side effects
The boxed warning for Tecvayli notes that cytokine release syndrome, a type of systemic inflammatory response, can occur and be life-threatening or fatal in people taking the medication. However, the therapy’s step-up dosing schedule may help reduce this risk. Serious and potentially life-threatening neurological complications, including immune effector cell-associated neurotoxicity syndrome, have also been linked to Tecvayli. Treatment may have to be paused or permanently discontinued if CRS or neurological complications occur.
The most common side effects of Tecvayli include:
- fever
- cytokine release syndrome
- musculoskeletal pain
- injection site reactions
- fatigue
- upper respiratory tract infections
- nausea
- headache
- pneumonia
- diarrhea
It is also common for people taking Tecvayli to experience decreases in blood cell counts.
Other potentially serious side effects of Tecvayli include:
- liver toxicity
- severe, life-threatening, or fatal infections
- dangerously low neutrophil counts, which can increase the risk of infections
- allergic reactions
Tecvayli may cause fetal harm if administered during pregnancy. It is recommended that females of reproductive potential use an effective method of contraception to avoid pregnancy during treatment and for at least five months after their last dose.
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