Will the MM drug Elrexfio be reimbursed this time?

The multiple myeloma drug Elrexfio makes second attempt at reimbursement in Korea

Whether the agenda will be presented for CDDC review gains attention

Korea is in need of expanding coverage for bispecific antibody treatment options

Whether progress will be made for the new multiple myeloma drug Elrexfio (elranatamab) in its second attempt to secure reimbursement in Korea is gathering attention.

 

According to industry sources, Pfizer Korea's bispecific antibody therapy Elrexfio (elranatamab) is expected to be submitted for reimbursement review to the Health Insurance Review and Assessment Service's next Cancer Disease Review Committee.

 

It remains to be seen whether Pfizer, which submitted a reapplication for Elrexfio’s reimbursement after its rejection by the HIRA Cancer Disease Review Committee last February, can achieve results within the year.

 

Elerexfio previously received approval through a Global Innovative products on Fast Track (GIFT) designation by the Ministry of Food and Drug Safety..

 

Elrexfio is a fourth-line immunotherapy composed of two monoclonal antibodies - one targeting the antigen specific to multiple myeloma and the other engaging T cells.

 

Bispecific antibody therapies are a form of immunotherapy composed of two monoclonal antibodies—one that recognizes a target antigen of multiple myeloma and another that binds to T cells.

 

Typically, they are structured as bispecific IgG2 kappa antibodies that recognize BCMA (B-cell maturation antigen), the primary target antigen in multiple myeloma, and CD3.

 

These therapies represent a novel approach that directly targets cytotoxic T cells to multiple myeloma cells expressing BCMA.

 

Multiple myeloma, a cancer of plasma cells in the bone marrow, is a type of hematologic malignancy that primarily affects older adults.

 

It is a disease where prolonged treatment can bring extended survival.

 

Although various new therapies are being developed for the disease, monoclonal antibodies and bispecific antibody therapies are currently typically used in practice.

 

In particular, the bispecific antibody mechanism is regarded as a safe and effective treatment for relapsed and refractory multiple myeloma, in which resistance increases with each treatment cycle, shortening the remission period and reducing the available treatment options.

 

Since multiple myeloma is a disease where extended survival is achievable through continuous treatment, it is essential to have various therapeutic options available at each stage of treatment.

 

This is why extending reimbursement coverage to fourth-line and later therapies remains an urgent priority.

 

Currently, bispecific antibody therapies such as Elrexfio, Tecvayli (teclistamab), and Talvey (talquetamab) are approved in Korea, but none are granted reimbursement.

 

Amid the failed discussions over coverage of a series of bispecific antibody drugs in the early stages, whether any drug will be granted reimbursement and improve patient access is gaining attention.

 

Meanwhile, Elrexfio was designated by the Ministry of Food and Drug Safety as a GIFT item and was approved as a monotherapy for adult patients who have received more than three lines of treatment, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, in May last year.

 

The US FDA has also designated it as a breakthrough therapy and granted accelerated approval for the drug.

 

Elrexfio’s efficacy was demonstrated through the Phase II MagnetisMM-3 trial, an open-label, multicenter, non-randomized study that was conducted on 123 patients who had not received prior BCMA-directed therapy (i.e., BCMA-naïve patients).

 

Results of Cohort A showed that the drug recorded an objective response rate (ORR) of 61.0% and a complete response (CR) of 37.4%.

 

The progression-free survival (PFS) period was 17.2 months, and the overall survival (OS) period was 24.6 months, demonstrating an unprecedented long-term treatment effect.

 

The data demonstrated that Elrexfio provided long-term survival benefits and slowed down disease progression to improve the quality of life of patients who had no other treatment options.