Roche Presents Updated Data on Glofitamab, a Novel CD20xCD3 Bispecific Antibody, Demonstrating Robust Efficacy in Relapsed/Refractory Non-Hodgkin Lymphoma

June 14, 2020 /BioValleyBIOON/ -- Roche recently at the European Hematology Association (EHA) The latest data on glofitamab (formerly CD20-TCB), a CD20xCD3 T-cell-engaging bispecific antibody, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) were presented at the 25th Annual Meeting.

Latest results from the Phase I dose-escalation NP30179 study (NCT03075696) demonstrate that a fixed 12-cycle regimen of glofitamab (21 days per cycle) yields durable complete responses (CR) in heavily pretreated patients who had previously received a median of three prior lines of therapy.

Levi Garraway, M.D., Chief Medical Officer and Global Head of Product Development at Roche, stated, “Non-Hodgkin lymphoma (NHL), such as diffuse large B-cell lymphoma (DLBCL), can pose substantial treatment challenges, particularly in cases involving multiple relapses. We are encouraged by these early results, which support the potential of glofitamab for patients who have experienced prior treatment failures and are in urgent need of new therapeutic options.”

Updated efficacy data from the ≥0.6 mg and ≥10 mg cohorts demonstrated high response rates across all NHL subgroups:

—In the ≥0.6 mg cohort, the investigator-assessed complete response (CR) rate was 30.9% (38/123) and the overall response rate (ORR) was 45.5% (56/123) in patients with aggressive non-Hodgkin lymphoma (NHL). In patients with indolent NHL, the investigator-assessed CR rate was 52.2% (12/23) and the ORR was 65.2% (15/23).

—In the ≥10 mg cohort, the investigator-assessed complete response (CR) rate was 34.1% (29/85) and the overall response rate (ORR) was 49.4% (42/85) in patients with aggressive NHL. In patients with indolent NHL, the investigator-assessed CR rate was 50.0% (9/18) and the ORR was 66.7% (12/18).

—CR demonstrated durability. Among patients who achieved CR in the ≥0.6 mg cohort, 72.7% (24/33) of those with aggressive NHL and 81.8% (9/11) of those with indolent NHL maintained CR as of the data cutoff date (April 17, 2020). With a median follow-up of 10.2 months, the median duration of CR was not reached in either group.

——The safety profile of glofitamab is consistent with its mechanism of action. In the ≥0.6 mg cohort (n=156), common adverse events occurring in more than 15% of subjects included cytokine release syndrome (CRS; n=88, 56.4%), neutropenia (n=48, 30.8%), and pyrexia (n=47, 30.1%),Anemia(n=35, 22.4%) and thrombocytopenia (n=26, 16.7%). Most CRS events were low-grade (Grade 1-2), associated with the first cycle, and manageable.

Glofitamab is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects the patient’s existing T cells to eliminate target B cells by binding to them and releasing cytotoxic proteins. Glofitamab features a novel “2:1” structural format, engineered with two CD20-binding Fab regions and one CD3-binding Fab region.

Currently, Roche is advancing a robust clinical development program for glofitamab, evaluating the molecule as a monotherapy and in combination with other agents for the treatment of CD20-positive B-cell non-Hodgkin lymphoma (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]) and other hematologic malignancies.

Among these, combination therapy includes studies investigating glofitamab in combination with Polivy (polatuzumab vedotin), Tecentriq (atezolizumab), MabThera/Rituxan (rituximab), and Gazyva/Gazyvaro (obinutuzumab) in non-Hodgkin lymphoma (NHL) and other hematologic malignancies, across various treatment settings andTumorTypes, including early treatment, to determine in which situations glofitamab can provide therapeutic benefits compared to current treatment regimens.(Bioon.com)

Original Source: Roche presents updated data on novel CD20xCD3 bispecific cancer immunotherapy glofitamab in people with heavily pre-treated non-Hodgkin lymphomas