Combination treatment halves risk in lymphoma study
A phase 3 study by Genmab and AbbVie reports better outcomes, but the combination has not yet been approved.
A combination of epcoritamab and existing R-CHOP treatment reduced the risk of disease progression or death in a phase 3 study of newly diagnosed diffuse large B-cell lymphoma. The companies have announced the topline results; the full results still need to be published and assessed by regulators.
On Monday, Genmab and AbbVie announced so-called topline results from the EPCORE DLBCL-2 study. In the trial, patients with newly diagnosed diffuse large B-cell lymphoma, a form of non-Hodgkin lymphoma, received either epcoritamab alongside R-CHOP or R-CHOP alone.
According to the companies, the risk of disease progression or death fell by 51 per cent in the combination group compared with the control group. The reported hazard ratio was 0.49. The result was statistically significant in the pre-planned interim analysis, after which an independent committee recommended unblinding the trial for this outcome.
Epcoritamab is a so-called bispecific antibody. It binds to immune cells and to a protein on B cells, with the aim of directing the immune system towards the cancer cells. The medicine has already been authorised in certain countries for some forms of relapsed or difficult-to-treat lymphoma, but the combination with R-CHOP for newly diagnosed patients has not yet been approved.
The results do not yet mean that this is a new standard treatment. The companies have not yet published the full study data, including all outcomes, side effects and subgroup analyses. They say they plan to present the data at a future medical conference and discuss them with European and other regulators.
Reuters reported that Genmab’s share price rose sharply after the news. That is a response from investors, not a medical assessment of the treatment. According to the companies, the safety profile was generally comparable to that of the individual medicines.
For patients, the news therefore mainly means that the study has produced a promising result, not that they should change their treatment. Full publication and assessment by independent experts will have to show which patients benefit precisely from the combination, how long the effect lasts and how the risks compare with existing options.
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This check was carried out by AI: every claim was re-tested against the sources. Even an approved article can contain errors — stay critical.
The reported phase 3 outcome and risk effect were checked with AbbVie and Reuters. The text makes clear that these are topline data and that approval and full publication are still pending.
- confirmed The combination reduced the risk of progression or death by 51 per cent. — This is stated in the company announcement about the interim analysis. source
- confirmed The study was a phase 3 trial. — AbbVie describes EPCORE DLBCL-2 as phase 3. source
- confirmed The combination has not yet been approved for newly diagnosed patients. — The company announcement describes the combination as investigational and not yet approved. source
- confirmed The full data have not yet been published. — The companies say that the data will be presented at a future medical conference. source
Editor's note
The study outcome was reported by the companies and independently covered by Reuters. The full data have not yet been published and the combination has not yet been approved.Sources
More on this in Dutch media
- de Volkskrant — „lymfoom kanker”
- RTL Nieuws — „lymfoom kanker”
- NOS — „lymfoom kanker”