What is the success rate of Tecvayli?

In the Phase 1/2 MajesTEC-1 study, the success rate of Tecvayli showed an overall response rate (ORR) of 61.8% (95%CI: 52.1 to 70.9%) in 110 patients with advanced multiple myeloma who had received at least 3 prior lines of therapy.

Tecvayli is a subcutaneous injection used to treat adults with multiple myeloma (bone marrow cell cancer) that has come back or failed previous treatment (relapsed or refractory multiple myeloma).

Study results with Tecvayli

In the Phase 1/2 MajesTEC-1 study submitted to the FDA for approval of Tecvayli (generic name: teclistamab-cqyv), researchers studied the overall response rate (ORR) and complete response rate, as well as response times in 110 patients with a median age of 66 years..

• Overall response rate is defined as the number of patients in a study whose tumor is destroyed (complete response) or significantly reduced (partial response) by a drug.
• Complete response does not always mean the cancer has been cured.

Initially, patients received increasing doses of Tecvayli (0.06 and 0.3 mg/kg) given subcutaneously (injected under the skin) over the first week. They then received weekly treatment doses of 1.5 mg/kg until the disease worsened or there were intolerable side effects.

In this study, an overall response rate (ORR) of 61.8% (95%CI: 52.1 to 70.9%) was seen (68 of 110 patients). In addition, 28.2% of patients achieved a complete response or better (31 of 110 patients).

The median time to first response was 1.2 months (range 0.2 to 5.5 months) and the estimated duration of response was 90.6% at 6 months and 66.5% at 9 months.

Longer-term efficacy data

Longer-term research results with Tecvayli were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in abstract form.

Further results from the MajesTEC-1 study showed that at a median follow-up of 30.4 months, 165 patients exhibited an overall response rate (ORR) of 63%, with responses continuing to deepen and 46% of patients achieving a complete response (CR) or better.

In addition, the median duration of response (mDOR) increased to 24 months, the median progression-free survival (mPFS) increased to 11.4 months and the overall survival (mOS) improved to 22.2 months.

In patients who had reached a CR or better, the median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were not yet reached. Researchers estimated that 30-month DOR, PFS, and OS rates were 60.8%, 61%, and 74.2%, respectively.

Safety of Tecvayli

The most common side effects (>20%) in the safety population of MajesTEC-1 (n=165) were:

• Fever
• Cytokine Release Syndrome (CRS)
• Muscle and bone pain
• Injection site reaction
• Extreme tiredness
• Upper respiratory tract infection
• Nausea
• Headache
• Pneumonia (lung infection)
• Diarrhea

Tecvayli carries a Boxed Warning for Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), which can be fatal. A Boxed Warning is the FDA’s most stringent safety warning.

Other warnings and precautions include: severe or fatal liver toxicity, severe or fatal infections, low blood cell counts, allergic reactions or injection site reactions that may require treatment discontinuation, and harm to an unborn baby.

Tecvayli is only available through a restricted program called the Tecvayli REMS (Risk Evaluation and Mitigation Strategy) due to the risk of serious side effects: Cytokine Release Syndrome (CRS) and neurologic problems.

Related: Tecvayli Warnings, Precautions and Side Effects (in more detail)

Can I get Tecvayli every 2 weeks instead of every week?

If you have achieved and maintained a complete response (CR) or better with Tecvayli given weekly for a minimum of 6 months, you may now be able to receive Tecvayli subcutaneous (under the skin) injection every 2 weeks instead of every week. Speak with your healthcare provider to see if this is an option for you.

A complete response means that the tumor is destroyed by the drug but does not always mean the cancer has been cured.

Related questions

• What’s the difference between Tecvayli and Talvey?
• What is the mechanism of action for Tecvayli (teclistamab-cqyv)?
• Is Tecvayli FDA approved as a multiple myeloma treatment?

Studies for 2-week dosing with Tecvayli

In February 2024, the FDA approved Tecavyli to be given as a subcutaneous (under the skin) injection every 2 weeks to patients with advanced multiple myeloma who have achieved and maintained a complete response (CR) or better for a minimum of 6 months.

• Approval for every 2 week dosing was based on the results seen in the Phase 1/2 MajesTEC-1 study with 165 participants.
• When patients reached a complete response or better for 6 months or longer on once weekly dosing of 1.5 mg/kg, they were then eligible to reduce dosing frequency to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
• Your healthcare provider will determine your dose based on your weight.

Previously it was approved only for once weekly dosing, after initial step-up dosing. When you first receive Tecvayli, you will start the medicine in lower doses ("step-up") over the first week to help reduce the risk of serious side effects.

Longer-term data on every 2 week dosing

Long-term, follow-up results from the Phase 1/2 MajesTEC-1 trial showed that 37 out of 38 patients who remained on therapy and switched to every 2 week dosing were able to maintain their clinical responses.

In this portion of the study, patients had the option to switch to every 2 weeks dosing if they exhibited a partial response or better after 4 or more cycles of therapy (in Phase 1) or they had a complete response or better for at least 6 months (Phase 2).

What is Tecvayli approved by the FDA to treat?

Tecvayli received accelerated approval by the FDA on October 25, 2022 to treat adults with multiple myeloma (cancer of cells in the bone marrow) that has come back or failed previous treatment (known as relapsed or refractory multiple myeloma).

Multiple myeloma is an incurable blood cancer that affects white blood cells found in the bone marrow. The cancerous white blood cells, called plasma cells, multiply out of control and replace healthy cells found in the bone marrow.

Tecavyli was approved for a group of patients with multiple myeloma with limited treatment options. These patients had received at least 4 other cancer therapies, including from different classes like a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and their cancer has come back or did not respond to prior treatment

Continued approval for this use may depend upon results and description of the clinical benefit in additional studies.

How does Tecvayli work in multiple myeloma?

Tecvayli works by binding to certain white blood cells to allow the immune system to better find and attack the cancer cells. It binds in 2 places: to the B-cell maturation antigen (BCMA) found on the surface of the multiple myeloma cancer cells (and some healthy B-cells) and to the CD3 receptor, a protein found on the surface of T-cells.

It is a monoclonal antibody and a first-in-class, bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.

Tecvayli is manufactured by Janssen Pharmaceuticals.

This is not all the information you need to know about Tecvayli (teclistamab-cqyv) 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.