Epcoritamab (3) – Tepkinly®

• Clinical trials
  • The GCT3013-01 trial is a single-arm, ongoing Phase I/II trial in adults with various forms of relapsed/refractory (r/r) B-cell lymphoma.

a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two previous systemic therapies, who are eligible for CAR-T cell therapy or stem cell transplantation

• For patient group a), the additional benefit is not proven.
• Due to its single-arm design, the study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy.
• Overall, the data submitted are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of epcoritamab as monotherapy for the treatment of adults with r/r DLBCL following at least two lines of systemic therapy is not proven.

b) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two previous systemic therapies, who are not eligible for CAR-T cell therapy and stem cell transplantation

• For patient group b), the additional benefit is not proven.
• Due to its single-arm design, the study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy.
• Overall, the data submitted are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of epcoritamab as monotherapy for the treatment of adults with r/r DLBCL following at least two lines of systemic therapy is not proven.

Courtesy translation only, please refer to the German original.