Bispecific multiple myeloma drug 'Talvey' can be prescribed

at general hospitals

Has passed drug committees (DC) of medical institutes, including Samsung·SNU hospitals

Used as a monotherapy option for patients with relapsed or refractory multiple myeloma who have received three prior lines or more treatments

Product photo of Talvey

New bispecific multiple myeloma drug 'Talvey' can now be prescribed at general hospitals.

 

According to industry sources, Janssen Korea's Talvey (talquetamab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National Univeristy Hospital, and medical institutes, including Pusan National University Hospital and Chung-Ang University Hospital.

 

Talvey was approved by the Ministry of Food and Drug Safety (MFDS) as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received over three prior lines of treatments, including proteasome inhibitors, immune modulators, and anti-CD38 monoclonal antibody.

 

Multiple myeloma is a type of cancer with the number of patients increased by over 60% in the past 10 years.

 

Many patients with multiple myeloma experience relapse.

 

According to a cohort study, multiple myeloma patients who had received more than three types of treatments, including anti-CD38 monoclonal antibody, demonstrated an overall response rate (ORR) of below 30%, with short life expectancy and poor prognosis.

 

Consequently, patients needed a treatment option with a new mechanism.

 

Talvey is a first-in-class bi-specific antibody drug approved in South Korea, targeting CD3 receptor and G protein-coupled receptor class C group 5 member D (GPRC5D).

 

It can be administered to patients who had previously used proteasome inhibitors, immune modulators, or anti-CD38 monoclonal antibodies.

 

The efficacy of Talvey was demonstrated through the global clinical trial, 'MonumenTAL-1 study.' The study results showed that 143 patients who do not have prior treatment experience with T-cell redirecting therapy were treated with Talvey 0.4 mg/kg every week.

 

The patients treated with Tarvey had an ORR of 74.1% and a stringent complete response (sCR) of 24%.

 

Patients demonstrated 10% complete response (CR) and 26% very good partial response (VGPR).

 

Meanwhile, bispecific antibody drugs are immune cell therapy consisting of two monoclonal antibodies that recognize targeted antigens and T cells of multiple myeloma.

 

For instance, bispecific IgG2 kappa antibody, consisting of two monoclonal antibodies that recognize B-cell maturation antigen (BCMA) and CD3 antigens, is commonly used.

 

It is a new therapy that directly delivers cytotoxicity-triggering T-cells into multiple myeloma cells expressing BCMA.

 

Bispecific antibodies approved in South Korea include Pfizer's 'Elrexfio (elranatamab)' and Janssen's 'Tecvayli (teclistamab),' and Talvey.

 

These drugs remain as non-reimbursed drugs.