A New Treatment Option Emerges for Non-Hodgkin's Lymphoma

A new treatment option for managing refractory blood cancer, specifically Diffuse Large B-Cell Lymphoma (DLBCL), has completed its approval process in Korea. This approval primarily targets high-risk patients who frequently relapse and do not respond to existing treatments.

The newly approved "Epkinly" (ingredient: epcoritamab), a bispecific antibody developed by global pharmaceutical company AbbVie, is the first subcutaneous injection option for easy administration. Korean medical experts are optimistic that this drug will significantly extend patients' survival periods due to its efficacy and safety.

On the 10th, Professor Kim Jin-seok of the Hematology Department at Severance Hospital (Chairman of the Multiple Myeloma Research Committee of the Korean Society of Hematology) attended the press conference for the domestic approval of Epkinly by AbbVie Korea. He stated, "The clinical follow-up at 20 months showed an encouraging median overall survival (mOS) of 19.4 months, confirming it as an option to extend survival."

Diffuse Large B-Cell Lymphoma is typically a fast-growing type of Non-Hodgkin's Lymphoma (NHL) that affects B-cell lymphocytes, a type of white blood cell. It is the most common type of NHL globally, accounting for about 30% of all NHL cases.

This lymphoma can be observed not only in lymph nodes but also in external tissues and occurs more frequently in men than in women. According to the 2021 National Cancer Registry statistics, the number of newly diagnosed patients in Korea was recorded at 6,082, and the number is steadily increasing.

On the 20th of last month, Epkinly was approved by the Ministry of Food and Drug Safety as a third-line treatment for adult patients (18 years and older) with relapsed or refractory DLBCL after two or more systemic therapies. It is evaluated as the first subcutaneous injection among the bispecific IgG1 therapies approved for DLBCL in Korea. Utilizing Genmab's exclusive "DuoBody" technology, it simultaneously targets CD20 on B-cells and CD3 on T-cells, which are involved in the development and progression of cancer.

Professor Kim explained, "Bispecific antibodies are a relatively new treatment in the oncology field. CD20 is located on the surface of B-cells, and CD3 is on the surface of T-cells. Epkinly binds to both, inducing T-cells to kill cancer cells."

This dual action results in positive treatment outcomes. According to the global clinical trial "EPCORE NHL-1," which evaluated the efficacy and safety of Epkinly, the overall response rate (ORR) was reported to be 62%, with a complete response (CR) rate of 39%. Professor Kim noted, "We confirmed sufficient tolerability in patients undergoing third or later lines of treatment, and most adverse reactions were manageable."

Professor Yang Deok-hwan from the Hematology Department at Chonnam National University Hwasun Hospital, who attended the press conference, emphasized, "Lymphoma has about 100 subtypes, and among them, DLBCL accounts for over 30% of all lymphomas, making it the most common and aggressive subtype."

He added, "Even after the first-line standard therapy (R-CHOP), 30-40% of patients relapse or are unresponsive, necessitating progression to subsequent lines of therapy. Patients who relapse after autologous stem cell transplantation (ASCT) in the second-line treatment have poor prognoses, and those who relapse after CAR-T cell therapy in the third line also show poor treatment outcomes."

Professor Yang concluded, "In general, the response rates are low and survival rates are poor when treated beyond the third line. Currently, options for third-line and beyond are limited, and there is no consistent standard therapy, highlighting the urgent need for new options."