COLUMVI® (glofitamab), concentrate for solution for infusion
(vial containing 2.5 mg or 10 mg of glofitamab)

Swissmedic marketing authorisation number: 68297
Swissmedic marketing authorisation date: 07.11.2023

Marketing authorisation studies (1):

Indication: Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Phase: I/II

Summary: A multicentre, open-label study to evaluate the safety, efficacy, tolerability and pharmacokinetics of COLUMVI® (glofitamab) as a single agent in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (n=468).

The Swiss approval of COLUMVI® (glofitamab) is based on the results of the single-arm, pivotal phase II study extension in patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received at least two lines of systemic therapy, including an anti-CD20 antibody and an anthracycline (n=145).

The following efficacy data refer to the subgroup of patients who were pretreated with CD19-targeted CAR-T cell therapy (n=47/145), of whom there were 34 with DLBCL NOS, 6 with tFL, 4 with HGBCL and 3 with PMBCL. 88.5% of patients were already refractory during CAR-T therapy.

After a median follow-up time of 12.6 months, the overall response rate was 55.3% (n=26/47) and the proportion of patients with complete response was 40.4% (n=19/47). The remissions (complete or partial) were achieved after a short time: median after two treatment cycles (42 days). Complete remissions continued even after the end of the time-limited therapy: median for 14.4 months.

The most common adverse event in the 145 patients was cytokine release syndrome (CRS, 63%), which was generally of low severity (grade 3–4: 4%). Other common adverse events (≥ 20%) were neutropenia, anaemia, thrombocytopenia and skin rash.

Results were published in Dickinson et al., Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231.

Sponsor: F. Hoffmann-La Roche Ltd

Publication of the results of clinical trials
Publication of the results of clinical trials The information given above and the links to the clinical data fulfill the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Columvi. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.

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