Will Epkinly become a game-changer in the blood cancer mkt?

AbbVie hosts press conference to celebrate Epkinly’s domestic approval on the 10th

Highlights the role of bispecific antibodies in the third-line treatment of DLBCL, an area that lacks options

Epkinly’s approval study showed a median survival of 19.4 months, confirming the potential on extended patient survival

May settle as a complementary option to CAR-T therapies...reimbursement issue a concern

The arrival of bispecific antibody-based therapies in Korea is expected to shift the blood cancer treatment market paradigm.

 

The industry is welcoming the introduction of a new treatment option, as an unmet need exists in diffuse large B-cell lymphoma (DLBCL), which has a poor prognosis even after three or later lines of treatments.

 

AbbVie hosted a press conference on the 10th to highlight the significance of Epkinly’s approval.

 

Professor Jin Seok Kim.

 

Department of Hematology-Oncology at Severance Hospital, is presenting data related to blood cancer.

AbbVie hosted a press conference on the 10th to celebrate the launch of 'Epkinly (epcoritamab)’ as a third-line treatment for DLBCL and highlight the implications of the approval.

 

Epkinly was approved by the Ministry of Food and Drug Safety in late June for the treatment of adult patients with relapsed or refractory DLBCL who have received 2 or more prior systemic therapies.

 

Epkinly is a humanized bispecific antibody (IgG1) that binds to CD20 on B cells and CD3’s extracellular specific epitopes on T cells.

 

It has a mechanism of action that induces specific T-cell activation and T-cell-mediated CD20-expressing cell death by simultaneously acting on CD20-expressing cancer cells and CD3-expressing endogenous T cells.

 

Epkinly is the first subcutaneous bispecific antibody approved in Korea for the treatment of DLBCL.

 

It has the advantage of being administered in less than one minute, allowing for a relatively short hospital stay and rapid treatment.

 

The duration of the treatment is not limited and can be administered until disease progression or unacceptable toxicity Epkinly’s approval is noteworthy because it provides a new option in the treatment of DLBCL, an area with much unmet need.

 

Professor Deok Hwan Yang, Department of Hematology-Oncology at Chonnam National University Hwasun Hospital, said, "Even after receiving first-line standard therapy for DLBCL, 30 to 40% of patients relapse or become refractory to treatment and move on to the next line of treatment.

 

Patients who relapse after receiving autologous stem cell transplantation as a second-line treatment have poor prognosis, and patients who relapse after receiving CAR-T as a third-line treatment also have poor outcomes." This means that patients who relapse after receiving three or more lines of treatment generally have a poor prognosis, with lower overall response rates and worse survival outcomes.

 

"Currently, there are limited options in the third and later lines of treatment, with no set standard of care.

 

In this way, there is a large unmet need for new options.”

(From the left) Professor Deok Hwan Yang, Department of Hematology-Oncology at Chonnam National University Hwasun Hospital; Professor Jin Seok Kim.

 

Department of Hematology-Oncology at Severance Hospital

The study that became the basis of Epkinly’s approval is the EPCORE NHL-1 study, a non-randomized, single-arm trial.

 

Its efficacy analysis showed an overall response rate (ORR) of 62%, with 39% achieving complete response (CR).

 

Professor Jin Seok Kim.

 

Department of Hematology-Oncology at Severance Hospital, said, “We found Epkinly was well tolerated in heavily pretreated third-line patients, and most adverse events were manageable and predictable.

 

At 30 months of follow-up, median overall survival (mOS) was 19.4 months, confirming that it is a viable option for prolonging survival in this patient population." The advent of such bispecific antibody-based therapies sheds light on the question of how they will compare to CAR-T therapies that are being reimbursed through national health insurance.

 

Experts predict that bispecific antibody therapies such as Epkinly will become complementary options in the future, assuming that they also be reimbursed.

 

Professor Kim explained, "If you look at the average cost, I think they will be very similar to CAR-T therapies, and I don't think one can be a substitute for the other.

 

I think it's going to be a patient-specific choice because they have different targets, but I think there will be cost concerns."