COLUMVI (glofitamab) - Diffuse large B cell lymphoma (DLBCL)

The Committee deems that the clinical benefit of COLUMVI (glofitamab), solution for dilution for infusion at the dosages of 2.5 mg and 10 mg, is insufficient to justify public funding in the other clinical contexts of the marketing authorisation.

In view of: 

• the lack of comparative data and the consideration of two phase II studies (NP30179 and BiCAR), the findings of which do not allow any conclusions to be drawn as to the therapeutic improvement of glofitamab compared to the available alternatives for adult patients with relapsed or refractory DLBCL after at least two lines of systemic treatment;
• limited follow-up on the safety data of glofitamab with a median follow-up of less than 2 years in the NP30179 study and 5.85 months in the BiCAR study and a safety profile particularly marked by the frequent onset of cytokine release syndrome (CRS), grade 3-4 neutropenia and severe infection;
• a partially met medical need with a benefit of having an additional alternative for relapsed or refractory patients after at least two lines of DLBCL treatment;
• and pending the findings of the phase III study comparing glofitamab in association with gemcitabine and oxaliplatin (GemOx) to the R-GemOx (rituximab, gemcitabine, oxaliplatin) regimen, in relapsed or refractory DLBCL patients after at least 1 line of systemic treatment (STARGLO study);

the Committee deems that, based on the current data, and pending the findings of the STARGLO phase III study, COLUMVI (glofitamab) monotherapy provides no clinical added value (CAV V) in the therapeutic strategy of adult patients with refractory or relapsed diffuse large B cell lymphoma (DLBCL), after at least two lines of systemic treatment and who have failed to respond to or are ineligible for CAR-T cell-based medicinal products.