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December 11, 2020 // -- Roche recently released for the first time clinical safety and ability data for the third dual-specific antibody cevostamab (BFCR4350A) in the malignant hematology pipeline.
results showed that cevostamab showed significant efficacy and controlled safety in patients with recurring or resuscable multiple myeloma (R/R MM) who had previously received multiple therapies.
cevostamab is a pioneering (first-in-class) FcRH5xCD3 T cell that binds to dual-specific antibodies and works by targeting both FcRH5 and T cell surfaces on myeloma cells.
FcRH5 is a unique differentiated target, expressed on almost 100% of myeloma cells.
cevostamab structure is similar to a human natural antibody, but contains 2 Fab regions, one of which targets FcRH5 and the other of which targets CD3.
This dual targeting activates and reboots the patient's existing endogenous T cells, binds to myeloma cells expressing FcRH5, and eliminates these target malignancies by releasing cytotoxic proteins into the target myeloma cells.
FcRH5xCD3 (photo from the literature: PMID 32659909) Currently, Roche is conducting a dose increment and expansion phase I GO39775 study (NCT03275103) to evaluate cevostamab as a single-drug therapy for overtreatment (heavily pre-treated, i.e., R/R MM adult patients who have received multiple treatments).
In patients in this study, the median previously accepted program was 6 and was allowed to receive R/R MM patient group studies that included CAR-T cell therapy, T-cell binding dual-specific antibodies, dual-specific T-cell binding agents (BiTE), antibody congenital drugs (ADC, including BCMA targeted therapies), a group of patients in urgent need of new treatments, with no effective, appropriate, or acceptable treatment.
clinical safety and ability data published for the first time show that the total remission rate (ORR) of cevostamab therapy at effective doses was 53% (n=18/34).
It is worth noting that treatment responses were observed in high-risk patients, including those with a difficulty treating 5 different types of drugs (orR=41%, n=7/17) and those who had been treated with anti-BCMA therapy (ORR=63%, n=5/8).
study, the safety of cevostamab was controllable, and the most common treatment-related adverse event was cytokine release syndrome (CRS, 76%).
most CRS events are level 1-2 (level 1: 34%; level 2: 40%), which occurs in cycle 1.
3 CRS (2%) in 1 patient and no level 4 or 5 CRS events were observed.
() Original origin: Roche presents new data from its bispecific antibody portfolioacross a range of blood cancers