TEPKINLY (epcoritamab) - Diffuse large B-cell lymphoma (DLBCL)

The Committee deems that the clinical benefit of TEPKINLY (epcoritamab) 4 mg/0.8 mL concentrate for solution for injection and 48 mg solution for injection is substantial as monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy only in adult patients who have failed or are ineligible for CAR-T cell-based medicinal products.

Considering: 

• the absence of comparative data and a phase 1/2 study (EPCORE NHL-1), the results of which do not enable any robust conclusion to be reached with respect to the therapeutic contribution of epcoritamab compared to the available alternatives in adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy;
• limited follow-up on the safety data of epcoritamab, with a median follow-up of less than 25.5 months in the EPCORE NHL-1 trial, and a safety profile particularly marked by the frequent occurrence of cytokine release syndrome (CRS), as well as grade 3-4 neutropenia;
• a partially met medical need with a benefit of having an additional alternative for relapsed or refractory patients after two or more lines of DLBCL therapy;
• and pending the results of the phase 3 study comparing epcoritamab as monotherapy versus investigator’s choice of chemotherapy (rituximab-bendamustine or R-GemOx), in relapsed or refractory DLBCL patients after two or more lines of therapy including an anti-CD20 antibody, or refractory to/ineligible for autologous stem cell transplant (DLBCL-1 trial),

the Committee deems that, based on the current data, and pending the results of the phase 3 EPCORE DLBCL-1 trial, TEPKINLY (epcoritamab) as monotherapy provides no clinical added value (CAV V) in the care pathway for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy and who have failed or are ineligible for CAR-T cell-based medicinal products.