Roche's CD20xCD3 Bispecific Antibody Mosunetuzumab Achieves 60% Complete Response Rate in Relapsed/Refractory Follicular Lymphoma

December 14, 2021 /BioValleyBIOON/ -- Roche's Genentech recently announced at the 63rd American Society of Hematology (ASH) Annual Meeting in 2021CD20xCD3 T Cell Engaging Bispecific Antibody MosunetuzumabNew key data. Results continue to show that mosunetuzumab has a favorable benefit-risk profile in relapsed or refractory (R/R) follicular lymphoma (FL). FL is a slow-growing or indolent non-Hodgkin lymphoma (indolent-NHL).

Key results from the Phase 1/2 GO29781 study indicate that,In R/R FL patients who had previously received two or more lines of therapy, mosunetuzumab induced durable complete responses lasting at least 18 months.，Complete Response Rate (CR) Reached 60%, with a median progression-free survival (PFS) of 17.9 months (95% CI: 10.1-not evaluable). Among patients who experienced relief,The median duration of response (DOR) was 22.8 months.(95% CI: 9.7 - not evaluable). The most common adverse event (AE) was cytokine release syndrome (CRS), generally low-grade (mainly grade 1-2).

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said: "Despite initial treatment success, many patients with follicular lymphoma (FL) frequently relapse."Mosunetuzumab may become an efficient treatment option that can be used without cell collection or genetic engineering.Through mosunetuzumab, we also aim to provide aTherapies that can be administered in an outpatient setting。”

Genentech plans to submit new data to the U.S. Food and Drug Administration (FDA) in the near future.FDA) Approval. If approved,Mosunetuzumab has the potential to become the first-in-class CD20xCD3 T-cell engaging bispecific antibody for the treatment of NHL.Recently, Roche submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for mosunetuzumab, hoping to bring this drug to patients with non-Hodgkin's lymphoma (NHL) as soon as possible.

Mosunetuzumab has a structure similar to natural human antibodies but contains two Fab regions, one of which targets CD20 and the other targets CD3. In July 2020, the United StatesFDAGranted mosunetuzumab Breakthrough Therapy Designation (BTD) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

Mosunetuzumab is a CD20xCD3 bispecific antibody that functions by simultaneously binding to two different targets on two different cells (CD20 on the surface of malignant B cells and CD3 on the surface of T cells).This dual-targeting action activates and redirects patients' existing endogenous T cells, binding to and eliminating these malignant B cells by releasing toxic proteins into the target B cells. This dual-targeting therapy provides an innovative treatment approach for hematologic cancers, including non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

So far, inClinical TrialIn China, mosunetuzumab has shown promising responses in various types of NHL, including relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).

Currently, Roche is developing several bispecific antibody therapies. In addition to mosunetuzumab, its pipeline also includes glofitamab and cevostamab. At the ASH Annual Meeting, Roche will also present key data on these bispecific antibodies. (Bioon.com)

Source of the original text:Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab