What’s the difference between Tecvayli and Talvey?

Both Tecvayli and Talvey are bispecific CD3 T-cell engager antibody drugs used to treat multiple myeloma, but they target different proteins on the myeloma cancer cell to cause its death. Tecvayli targets B cell maturation antigen (BCMA) and Talvey targets G protein-coupled receptor, class C group 5 member D (GPRC5D).

Tecvayli and Talvey are prescription medications approved by the FDA for the treatment of adults with advanced forms of multiple myeloma, a cancer of the bone marrow that has come back (relapsed) or failed previous treatment (refractory).

Multiple myeloma is a cancer of the plasma cells found in the bone marrow. Plasma cells make antibodies which fight infection, but in multiple myeloma the plasma cells become cancerous, multiply and replace the healthy cells in the bone marrow.

How do Tecvayli and Talvey work in multiple myeloma?

Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. BCMA is found in high levels on multiple myeloma cells. T-cells are a type of white blood cell that helps to activate your immune system to kill the myeloma cells. Tecvayli activates the immune system by redirecting CD3-positive T-cells to BCMA-expressing myeloma cells to cause cell death.

Talvey (talquetamab-tgvs) is a bispecific GPRC5D-directed CD3 T-cell engager. This means it works by targeting G protein-coupled receptor, class C group 5 member D (GPRC5D) on myeloma cancer cells and CD3 on the surface of T cells found in your immune system. In lab studies, the activated T cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells.

Patients eligible for Tecvayli or Talvey have a high unmet medical need for treatment. Multiple myeloma in these patients has come back (relapsed) or did not respond to prior treatments (refractory) and they have already received at least 4 different treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

How are they given?

Both Tecvayli and Talvey are given as a subcutaneous (under the skin) injections. Both products are given on a weekly or biweekly (every 2 weeks) dosing schedule. Doses are based on your weight. Your healthcare provider will determine the best dose for you.

To be eligible for every 2 weeks dosing with Tecvayli, you should have achieved and maintained a complete response or better for a minimum period of 6 months. Talvey does not have this requirement.

Both drugs requires an initial step-up dosing phase over one week to be monitored for serious side effects. This requires the patient to be hospitalized for 48 hours after all doses within the step-up dosing schedule. If your dose is delayed for any reason, you may need to repeat the “step-up dosing schedule” again, or in some instances, may need to stop treatment.

The injections are given to you by a healthcare provider. They are usually given in the abdomen (stomach area) but may also be given in the thigh or other areas.

Both products are only available through the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of cytokine release syndrome (CRS) and neurologic problems. These are serious side effects and your healthcare provider will also provide for information about them.

It is not known if these products are safe and effective in children.

Related Questions

• What is the mechanism of action for Tecvayli (teclistamab-cqyv)?
• Is Tecvayli FDA approved as a multiple myeloma treatment?
• Where can I find the Tecvayli FDA package insert?

How do side effects compare between Tecvayli and Talvey?

Tecvayli and Talvey have both similar and different side effects as determined in safety studies leading to their FDA review. Because these studies were conducted in different patient populations of different sizes, side effect rates cannot be compared outside of a randomized, comparative controlled study.

Serious side effects

Both Tecvayli and Talvey can cause serious, possibly life-threatening side effects including Cytokine Release Syndrome (CRS) with immune system reactions and neurologic (nerve system) problems. Both products carry a Boxed Warning for these effects. Your healthcare provider will monitor you for signs and symptoms of serious side effects during your treatment.

Both products can cause other similar serious problems like liver problems, infections, decreased blood cell counts, and risks to an unborn baby.

• Other serious side effects reported in Tecvayli studies include allergic reactions and injection site reactions
• Additional Talvey serious side effects included mouth problems (sores, dry mouth, changes in taste, trouble swallowing) with weight loss, and skin problems.

Common side effects

The most common side effects occurring in at least 20% of patients receiving either Tecvayli or Talvey included:

• fever
• cytokine release syndrome (CRS)
• muscle and joint pain
• feeling tired or weak
• upper respiratory tract infection
• headache
• diarrhea
• laboratory changes in certain blood cell counts (for example, red blood cells, white blood cells, platelets)

Other common side effects for patients receiving Tecvayli included injection site reactions, nausea, and pneumonia (serious lung infection).

Other common side effects for patients receiving Talvey included taste changes, nail disorder, skin disorder, rash, decreased weight, dry mouth, dry skin, trouble swallowing, and low blood pressure.

Who makes Tecvayli and Talvey?

Both Tecvayli (generic name: teclistamab-cqyv) and Talvey (generic name: talquetamab-tgvs)are manufactured by Janssen Pharmaceuticals and received accelerated approval by the FDA. Tecvayli was approved on October 25, 2022 and Talvey was approved on August 9, 2023.

Accelerated approval means that in studies patients responded to treatment, but further studies are needed to confirm the clinical benefit to maintain the approved, marketable status.

Janssen also manufacturers Carvykti (ciltacabtagene autoleucel), a CAR-T cell immunotherapy, and Darzalex (​​daratumumab), a CD38 monoclonal antibody drug, both approved to treat multiple myeloma.

This is not all the information you need to know about Tecvayli and Talvey for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.