Roche CD3× CD20 dual anti-Glofitamab launches clinical trials in China for the first time

From: Insight Database () Glofitamab is a dual-specific antibody developed by Roche to target CD20 and CD3, where CD20 bits use a binding bit of a second-generation source CD20 monoantigenated CD20 mono-anti-Ottoju monoantigen.
the dual resistance comes from Roche's TCB technology platform, with 2 CD20 combined bits and 1 CD3 binding bit (i.e. 2:1 dual resistance).
Glofitamab is more binding to cd20 on the surface of B cells than traditional 1:1 dual resistance, inducing rapid T-cell activity, cytokine release, and target cell cleavage.
, the 2:1 structure also has another advantage, which can be used in a coalition with other types of anti-CD20 antibodies, providing the possibility for subsequent research and development of joint treatment options.
June 2020, Cyntaf and Roche reached a $2 billion strategic partnership to research, develop, and commercialize multiple dual-specific antibody and cell therapy products based on Roche's TCB dual-resistance platform and general purpose CAR-T platform.
Previously, Cyntaf has been the most extensive dual-resistance layout of enterprises, in addition to a number of preclinical projects, into the clinical has also 6 models, and after reaching a partnership with Roche, relying on Roche in 2:1 T cell dual-specific antibody platform advantages, Cyntaf's innovative dual-specific antibody product chain has also been consolidated and expanded.
Glofitamab has now initiated seven clinical trials abroad, including single-drug or co-treatment CD20-positive B-cell non-Hodgkin's lymphoma (including diffuse large B-cell lymphoma and fable lymphoma) and other blood cancers.
progress to Clinical Phase III.
from: Insight Database () At this year's EHA Annual Meeting, Roche reported positive results from glofitamab's Phase I dose incremental study in recurring or re treatable non-Hodgkin's lymphoma (R/R NHL).
NHL patients who received third-line treatment in the median, glofitamab demonstrated strong clinical efficacy, including longer-lasting remission and controlled safety.
results showed that in the ≥0.6 mg glofitamab dose group, the CR of invasive NHL patients was 30.9%, the overall remission rate (ORR) was 45.5%, and the CR of inert NHL patients was 52.2% and ORR was 65.2%.
in the ≥10mg group, invasive NHL patients had a CR rate of 34.1%, ORR was 49.4%, inert NHL patients had a CR rate of 50.0% and ORR was 66.7%.
for CR patients, the medium follow-up was 10.2 months, 72.7 percent of invasive NHL patients, and 81.8 percent of inert NHL patients remained CR.
in terms of safety, the most common adverse events that occurred in more than 15% of the subjects in the ≥0.6mg queue were cytokine release syndrome (CRS; n=88,56.4%), and a reduction in neutral granulocytes (n=48,30.8%), fever (n=47,30.1%), anemia (n=35,22.4%) and plateboard reduction (n=26,16.7%).
most CRS events are low-level (1-2) and manageable.
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