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December 09, 2020 // -- Roche recently released new data at the 62nd annual meeting of the American Society of Hematology (ASH) in the study of T-cell binding CD20xCD3 dual-specific antibodies mosunetuzumab and glofitamab.
results showed encouraging activity in a variety of blood cancers, with a total remission rate of 50-80%.
mosunetuzumab and glofitamab (formerly CD20-TCB) are CD20xCD3 dual-specific antibodies that work by binding to two different targets on two different cells at the same time (CD20 on the surface of malignant B cells and CD3 on the surface of T cells).
this dual-targeting action activates and redirects the patient's existing endogenal T cells, binding and eliminating these malignant B cells by releasing toxic proteins into target B cells.
this dual-targeted therapy provides an innovative treatment for blood cancers including non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).
So far, in clinical trials, Roche's two CD20xCD3 T cells, combined with dual-specific antibodies mosunetuzumab and glofitamab, have shown good results in several types of NHL, including recurring or refractic (R/R) folioma (FL) and diffuse large B-cell lymphoma (DLBCL).
latest results from the I/Ib phase GO29781 study of the treatment R/R FL further confirm this.
study showed that 51.6% of R/R FL patients treated with mosunetuzumab (n=32/62) received complete remission (CR).
glofitamab treatment also continued to show high rates of remission.
, for example, new data from the I/Ib phase NP30179 study that treated R/R NHL showed that 53.6 percent (n-15/28) of invasive R/R NHL patients treated with glofitamab received complete remission (CR).
In addition, two dual-specific antibodies have manageable safety, and one of the most common adverse events observed is cytokine release syndrome (CRS), which involves overactivation of immune cells and is a known risk of immunotherapy that activates the body's own immune system.
based on current studies, CRS events treated with mosunetuzumab and glofitamab are largely low-level (mainly level 1-2), occur during early treatment cycles, and are mostly reversible.
addition to R/R disease, mosunetuzumab and glofitamab are also being studied in early treatment, including first-line DLBCL (1L-DLBCL).
preliminary data from the GO40554 I/II study showed that in elderly or ill-health patients who were unable to withstand full-dose immunotheria, the CR rate for single-drug first-line treatment of DLBCL was 45.5% (n=10/22).
addition, the Ib/II phase GO40515 study data show that the CR rate of the first-line treatment of DLBCL with mosunetuzumab combined chemotherapy was 79.4% (n=27/34).
this is the first double-specific antibody study to report data in first-line DLBCL, and although it is still early days, these results support the potential of mosunetuzumab to provide these patients with a new, acute treatment option.
mosunetuzumab and glofitamab are structurally different, and the mosunetuzumab structure is similar to a human natural antibody, but contains two Fab regions, one of which targets CD20 and the other of which targets CD3.
glofitamab has a "2:1" novel structural pattern with 2 Fab zones targeted at CD20 and one Fab zone that targets CD3.
July, the FDA granted Msunetuzumab Breakthrough Drug Qualification (BTD) for the treatment of adult patients with recurring or incurable (R/R) folytic lymphoma (FL) who had previously received at least two system therapies.
these two antibodies are part of Roche's strategy to explore several dual-specific antibody models to identify options that maximize potential clinical benefits for patients.
Currently, Roche is advancing a strong clinical program to develop mosunetuzumab and glofitamab as monodrative therapies and combinations of other drugs, as well as more convenient administration methods such as subsurfic injection administration, to treat CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) and figular lymphoma (FL).
the company plans to launch several Phase 3 clinical trials in the near future.
() Original origin: Roche presents new data from its bispecific antibody portfolioacross a range of blood cancers