Roche’s COLUMVI gets EC’s nod for relapsed/refractory diffuse large B-cell lymphoma (DLBCL)

CAR-T Digest - August 2020

Weekly Digest - 11-17 Jul 2023

11 Jul 2023: COLUMVI (glofitamab-gxbm) / R/R DLBCL / Roche: Approved in the EU

Based on the results from the Phase 1/2 NP30179 study, glofitamab received conditional approval for R/R DLBCL (2L+) in the EU
Among the overall patient population 83.3% of patients were refractory to their most recent therapy, 90% were refractory to any previous line of therapy, and about one-third (35.2%) had received prior CAR T-cell therapy
Efficacy: (Glofitamab given as a fixed course)
- ORR: 50% (n=54/108); CR: 35.2% (n = 38/108)
  - Among those who achieved a CR, 74.6% continued to experience a response at 12 months
  - Median duration of CR not reached
- The median follow-up for the duration of response was 12.8 months
Safety:
- Most common AEs: Cytokine release syndrome (CRS, 64.3%), neutropenia (37.7%), anaemia (30.5%), and thrombocytopenia (24.7%))
- CRS was generally low grade (Grade 1: 48.1%; Grade 2:12.3%)
- Due to CRS, one patient discontinued treatment
Additional data from the larger cohort of the NP30179 study published in the New England Journal of Medicine reinforce the durability Of Glofitamab:
- Glofitamab resulted in early and long-lasting responses
  - CR: 39.4% of patients (n=61/155)
  - median DOR: 18.4 months
With this conditional approval, Glofitamab becomes the first CD20xCD3 T-cell-engaging bispecific antibody to be available in Europe for DLBCL
In Jun’23, US-FDA had approved (accelerated approval) glofitamab for the same patient segment, commercial launch in the US is expected in late 2023
- It is also approved in Canada for r/r DLBCL NOS; DLBCL arising from follicular lymphoma (FL), or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy