What Is Talvey?
TALVEY™ (also known as talquetamab, the generic drug name) is a bispecific monoclonal antibody with a novel target, GPRC5D, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The FDA approved it for this use in August 2023.
How Does Talvey Work?
Talvey targets a new receptor on the surface of myeloma called GPRC5D, which is a G protein coupled with receptor known as class five and member D. This receptor is unique; it is an orphan receptor. Under normal circumstances, it is not understood what this receptor does.
Talvey is made from the coupling of the anti-GPRC5D antibody with CD3 protein complex on lymphocytes. The GPRC5D receptor is heavily expressed in myeloma. T lymphocytes play a vital role in protective immunity. Talvey works by engaging the T lymphocytes to activate a person’s immune system to attack myeloma cells.
How Does Talvey Differ from CAR T-cell Therapy?
Talvey differs from CAR T-cell therapy in that there is no need to collect the patient’s T cells. Instead, Talvey engages the patient’s T cells directly after injection. Not having to collect, engineer, and manufacture T cells over the course of several weeks shortens the time-to-treatment for the myeloma patient.
When Should Talvey Be Used as a Treatment?
Talvey is FDA-approved for patients with relapsed or refractory myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
How Has Talvey Been Used in Clinical Trials?
MonumenTAL-1 trial
The safety of Talvey was evaluated in the MonumenTAL-1 clinical trial. This trial evaluated adult patients with relapsed or refractory myeloma. Patients received subcutaneous Talvey once every two weeks with “step-up” dosing to reduce side effects.
- The overall response rate on this trial was more than 70%.
- The median progression-free survival (or, response time) was nine months or better.
How Will Talvey Be Made Available to Patients?
Because of its unique toxicities, Talvey will be made available to patients through a special REMS program. A REMS programs is a Risk Evaluation and Mitigation Strategy (REMS). It is “a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
How Should Talvey Be Administered, Dosed, and Scheduled?
The International Myeloma Foundation (IMF) will soon be releasing a full booklet on Talvey. Until it becomes available, the IMF encourages patients to follow the dosing information on the manufacturer’s website here.
Talvey Weekly Dosing Schedule
| Dosing schedule | Day | Dose | Dose |
| Step-up dosing | Day 1 | Step-up dose 1 | 0.01 mg/kg |
| Step-up dosing | Day 4 | Step-up dose 2 | 0.06 mg/kg |
| Step-up dosing | Day 7 | First treatment dose | 0.4 mg/kg |
| Weekly dosing schedule | One week after first treatment dose and weekly thereafter | Subsequent treatment doses | 0.4 mg/kg once weekly |
Talvey Biweekly (Every 2 Weeks) Dosing Schedule
| Dosing schedule | Day | Dose | Dose |
| Step-up dosing | Day 1 | Step-up dose 1 | 0.01 mg/kg |
| Step-up dosing | Day 4 | Step-up dose 2 | 0.06 mg/kg |
| Step-up dosing | Day 7 | Step-up dose 3 | 0.4 mg/kg |
| Step-up dosing | Day 10 | First treatment dose | 0.8 mg/kg |
| Weekly dosing schedule | One week after first treatment dose and weekly thereafte | Subsequent treatment doses | 0.8 mg/kg every two weeks |
What Warnings and Precautions Should Patients Who Undergo Talvey Therapy Be Aware Of?
The International Myeloma Foundation (IMF) will soon be releasing a full booklet on Talvey. Until it becomes available, the IMF encourages patients to learn about potential Talvey side effects and complications on the manufacturer’s website here. The medication label insert provides full details.
