Roche's Glofitamab Receives EMA Approval as First-in-Class CD20/CD3 Bispecific Antibody Combination Therapy for Relapsed or Refractory DLBCL

Apr 14, 2025 16:07 CST Updated 16:07

Roche

Oncology Drug Research, Development, and Manufacturing

On April 14 local time, Roche announcedGlofitamab（Glofitamab）Combination of Gemcitabine and Oxaliplatin（GemOx）Combination therapy receives EMA approval for useTreatmentNot Suitable for Autologous Stem Cell Transplantation（ASCT）Relapsed or Refractory（R/R）Diffuse Large B-Cell Lymphoma（DLBCL）Adult patients.

After this approval,The combination therapy of Grophefitumab has becomeThe First in EuropeA bispecific antibody treatment regimen for DLBCL patients with cancer recurrence or no response to initial treatment.

Screenshot source: Corporate official website

Gefitumab isA CD20/CD3 T cell-engaging bispecific antibody that simultaneously binds to CD20 on the surface of B cells and CD3 on the surface of T cells, mediating the formation of immune synapses, subsequently inducing T cell activation and proliferation, cytokine secretion, and release of cytolytic proteins, thereby leading to the lysis of CD20-expressing B cells.

Insight database shows that the drug was approved for marketing by the FDA in June 2023, for use in...DLBCL Third-line Treatment Approved by EMA in June and NMPA in November of the Same Year.

Screenshot source: Insight database

This approval is based on the results of the pivotal Phase III STARGLO study. This isA Study Evaluating Gefitumab in Combination with GemOx in R/R DLBCL PatientsRituximabA Phase III, Open-label, Multicenter, Randomized Study of the Efficacy and Safety of GemOx Combination.The primary endpoint of the study is OS.

The results showed that, for R/R DLBCL patients, compared toComparison of Rituximab Combined with GemOx and Gefitinib Combined with GemOxOS Significantly Improved。

In the preliminary analysis(After a median follow-up period of 11.3 months)In, andCompared with Rituximab combined with GemOx, receivingPatients Treated with Gefitumab Combined with GemOxThe risk of death was reduced by 41%.(Hazard Ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011)。

GefitumabThe combination therapy also achieved its key secondary endpoint, compared withRituximab Combined with GemOxIn comparison,PFS Decreased by 63%（HR=0.37；95% CI：0.25–0.55，p<0.0001）。

All patients were followed up for analysis after completing the treatment.(Median follow-up period was 20.7 months)`, showing acceptance`Patients Treated with Glevituzumab Combination TherapyThe median OS was 25.5 months, nearly that of receivingRituximab CombinationTwice the number of patients treated with GemOx（vs12.9 months）。

In addition,The number of patients who achieved complete remission isRituximab Combined withMore than twice the GemOx(58.5% and 25.3%, respectively)。

Roche has multiple product portfolios targeting the CD20 antigen.In addition to the second-generation CD20 monoclonal antibody Ocrelizumab, Roche also has representative products in the first and third generations, such as the first generation'sRituximab, Third GenerationObinutuzumab, and 2 more.CD3/CD20 Bispecific AntibodyMotoregulin andGefitumab, In addition, a new product was introduced in August 2022.CD19/CD20 Dual-Target CAR-T Therapy（RG6540）。

Cover Source:Corporate Logo

Disclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.

Editor：ccai

PR Article Coordination: WeChat insightxb

SubmissionWeChat: insightxb; Email: insight@dxy.cn