The race for dominance in Korea's market for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treatments has reached a turning point. Following CAR-T Therapy, off-the-shelf CD20×CD3 Bispecific Antibody therapies that can be administered immediately are set to clash as they near entry into National Health Insurance reimbursement.
The current competition is essentially between Roche's "Columvi" and AbbVie's "Epkinly." Columvi recently cleared the first reimbursement hurdle, narrowing the gap with Epkinly, which has already passed the second.
DLBCL is the most common and aggressive blood cancer, accounting for a high proportion of all hematologic malignancies (around 15%). The number of patients in Korea is estimated at about 3,272 as of 2022.
At present, the only reimbursed therapy in this market is Novartis' CAR-T Therapy "Kymriah (third-line treatment)." Assuming Kymriah is priced at about 360 million won, the domestic market size is expected to exceed 200 billion won this year. If Bispecific Antibody therapies enter in earnest, both reimbursement finances and prescribing patterns could be reshaped.
◇ Columvi joins the reimbursement track after clearing the cancer committee; chasing Epkinly with the "OS variable"
The Health Insurance Review & Assessment Service (HIRA) on the 4th set reimbursement criteria for Columvi as a second- and third-line treatment at the 2026 second Cancer Disease Review Committee (cancer committee). After being rejected right after approval at the end of 2023, the drug reattempted and made it onto the reimbursement review track. Phase 1/2 monotherapy data formed the basis.
The reimbursement process for anticancer drugs in Korea is multi-layered. Drugs that pass the cancer committee are evaluated for clinical usefulness and cost-effectiveness by the Drug Benefit Evaluation Committee. They then undergo price negotiations with the National Health Insurance Service, and the Health Insurance Policy Deliberation Committee makes the final decision on reimbursement and price.
In terms of speed, Epkinly is ahead. It has already passed the cancer committee and the drug evaluation committee. However, monotherapy phase 3 results released early this year have emerged as a potential variable for future price negotiations.
In this study, Epkinly improved progression-free survival (PFS) by 26%, meaning it reduced the risk of disease progression or death. Complete response rate (CRR) and duration of response (DoR) also improved.
However, overall survival (OS) did not reach statistical significance. OS indicates how much longer patients actually lived and serves as a key basis for assessing cost-effectiveness in reimbursement evaluations.
A HIRA official said, "Epkinly's recent phase 3 targeted the second-line setting, which differs from the third-line indication currently under review," drawing a line on any direct connection.
Still, the industry notes that with Columvi's reimbursement criteria set up to second line, Epkinly's failure to achieve statistical significance this time could burden the company during price talks with the insurance service. Columvi significantly improved OS in a subsequent phase 3 combination study targeting second-line patients.
◇ Two drugs diverge in structure and administration; "intensity of immune stimulation" also differs
Both are CD20×CD3 Bispecific Antibodies, but they are designed differently.
Columvi has a "2:1 structure," with two arms binding CD20 on the cancer cell surface and one arm binding CD3 on T cells. During treatment, cancer cells may reduce CD20 on their surface to survive, or existing therapies may already occupy the target, making it harder for new drugs to bind. Columvi grips with two arms simultaneously to lower the chance of dissociation.
Its backbone is an IgG1 antibody that strongly induces an immune response. While that yields potent tumor killing, it can also carry risks of immune-related adverse events such as cytokine release syndrome (CRS). To control this, the pre-treatment antibody "obinutuzumab" is given seven days before dosing. Administration is by intravenous infusion (IV).
Epkinly has a "1:1 structure," binding one each to CD20 and CD3. Its backbone is an IgG4 antibody, which is relatively less immunostimulatory. The design focuses on T-cell engagement while reducing excessive immune activation by the antibody itself. It is administered subcutaneously (SC) and, unlike Columvi, requires no premedication, adding convenience as a strength.
Their treatment strategies also differ.
Columvi uses a "fixed duration" strategy, ending treatment after up to 12 cycles (about 8.5 months). After an intensive period, dosing stops and outcomes are monitored. For patients, there is clarity on when treatment ends, along with the ability to anticipate the expense burden and toxicity accumulation associated with long-term dosing.
Epkinly follows a "treat-to-progression" strategy, continuing dosing until disease progression. Treatment stops when the tumor grows again, new cancer cells are found, or the patient cannot tolerate toxicity. This can provide psychological reassurance for high-risk patients, but it entails cumulative expenses and management burdens from long-term dosing.
◇ The outcome hinges on budget predictability; what will the insurance service choose?
Price negotiations with the insurance service hinge on economic evaluation. For now, observers see Columvi as having the edge. Epkinly's treat-to-progression model makes it hard to fix each patient's total treatment cost in advance, whereas Columvi has a set maximum dosing period, making per-patient total expense easier to predict.
If Epkinly's failure to improve OS works against it in future negotiations, Columvi may have room to demand better terms based on relatively superior clinical results. Cho Won-young, insurance director at the Korean Medical Association Organization on the drug evaluation committee, said, "For drugs that fail to demonstrate OS improvement, adjustments such as lowering the price or increasing the rebate rate may be made during negotiations."
An AbbVie official said, "The phase 3 period overlapped with the COVID-19 pandemic, and new treatments also emerged," adding, "We believe various factors influenced the results, and we are evaluating them."