Roche Korea is making another attempt to secure reimbursement approval for Columvi (glofitamab), its CD20-CD3 bispecific antibody therapy for diffuse large B-cell lymphoma (DLBCL). The Severe Disease (Cancer) Review Committee is set to review the application on November 13.

DLBCL, a highly aggressive form of non-Hodgkin lymphoma caused by abnormal B-cell proliferation, accounts for 40–50% of all cases. Unlike less severe cancers like follicular lymphoma, DLBCL is marked by rapid tumor growth and metastasis.

Approved by the Ministry of Food and Drug Safety last December for patients with relapsed or refractory DLBCL who have undergone at least two prior systemic therapies, Columvi is the first bispecific antibody targeting B-cell lymphomas. It binds to the CD20 domain on malignant B-cells and the CD3 domain on immune T-cells, activating an immune response.

Roche's reimbursement efforts began in July but initially failed to establish coverage criteria. The company resubmitted the application in September, continuing its push to make the therapy accessible.

Clinical trials underline Columvi's potential. In the Phase 1/2 NP30179 trial involving 155 patients, the therapy demonstrated a complete response rate (CRR) of 40% and an overall response rate (ORR) of 52%. Additionally, results from the Phase 3 STARGLO trial, presented at the European Hematology Association (EHA), showed Columvi combined with gemcitabine and oxaliplatin reduced the risk of death by 41%, extending median overall survival (mOS) to 25.5 months, compared to 12.9 months for the control group. The combination also achieved a CRR of 58.5%, significantly outperforming the control group’s 25.3%, with a 63% reduction in the risk of disease progression or death.

Patient advocacy groups, including leukemia organizations, have called on Roche to propose cost-sharing measures to facilitate reimbursement. Despite the company’s push, securing approval remains an uphill battle. The industry is closely watching to see if Columvi can secure a spot in one of the two remaining cancer reimbursement reviews this year.

Meanwhile, Novartis Korea’s Kymriah (tisagenlecleucel), another DLBCL treatment, successfully achieved reimbursement in 2022 at a maximum price of $258,000.