CD20xCD3 bispecific antibodies! Rochemosuuzumab is qualified by FDA for breakthrough drug treatment for follicular lymphoma (FL)

!--webeditor:page title"--July 14, 2020 /PRNewswire/ -- Roche has announced that the U.SFood and Drug Administration (FDA) has granted the Mosunetuzumab Breakthrough Drug (BTD), a T-cell-combined CD20xCD3 bispecific antibody used to treat recurrent or refractive (R/R) patients who have previously been treated with at least two systemic therapiesBTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases and have initial clinical evidence that the drug can significantly improve the condition compared to existing therapeutic drugsaccess to BTD drugs, developed with closer guidance, including from top FDA officials, to ensure that patients are offered new treatment options in the shortest possible timeFDA awarded mosunetuzumab BTD based on encouraging efficacy observed in the I/Ib GO29781 study (NCT02500407)the study, a multicenter, open-label, dose-increasing I/Ib study that assessed the safety and pharmacokinetics of mosunetuzumab in patients with recurrent or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)the patients enrolled in the study included patients who had a recurrence of the disease after receiving CAR-T cell therapy or were resistant to CAR-T cell therapy, with limited treatment optionsThe purpose of thestudy was to assess the optimal objective mitigation rate (ORR, using revised International Working Group standard assessment), maximum tolerability dose and tolerancelate last year, results released at the 2019 American Society of Hematology (ASH2019) showed encouraging results: (1) in ORR, 62.7 percent (n-42/67) in inert NHL patients and 37.1 percent of invasive NHL patients (n-46/124)(2) total remission rate (CR), the inert NHL patients were 43.3 percent (n-29/67) and the invasive NHL patients were 19.4 percent (n-24/124)(3) CR showed persistence, 82.8 percent (n-24/29) in inert NHL patients were still in remission for 26 months after initial treatment, and 70.8 percent of invasive NHL patients (n-17/24) were still in remission 16 months after initial treatment(4) in patients previously treated with CAR-T cell therapy, the ORR was 38.9% (n-7/18) and CR was 22.2% (n-4/18)(5) adverse reactions, 28.9% of patients developed cytokine release syndrome (CRS), of which 20.0% were level 1, 1.1% were level 3, and level 3 neurological adverse events occurred in 3.7% of patients"We are pleased that the FDA has granted the mosunetuzumab breakthrough drug, which demonstrates the agency's recognition of the early efficacy data for the drug and the outstanding medical needs in the FL field," said DrLevi Garraway,'s Chief Medical Officer and Global Head of Global Product Development in fact, we are excited about the potential of CD20xCD3 bispecific antibodies (mosunetuzumab and glofitamab) in the clinical development of refractive lymphoma, and continue to work on the development of innovative therapies to improve patient synodcyst outcomes "mosunetuzumab and glofitamab (formerly CD20-TCB) are CD20xCD3 T cells that bind bispecific antibodies, targeting CD20 and CD3 on the surface of B cells this dual-targeting activates and redirects the patient's existing T cells to eliminate target B cells by releasing toxic proteins into B cells two antibodies are structurally different, and mosunetuzumab is similar to a natural human antibody, but contains two Fab regions, one of which targets CD20 and the other Fab region targets CD3 glofitamab has a novel structure pattern of "2:1" with two Fab zones that target CD20 and a Fab zone that targets CD3 these two antibodies are part of Roche's strategy to explore several bispecific antibody models to determine options for patients to maximize potential clinical benefits currently, Roche is developing mosunetuzumab and glofitamab as monodrug therapy as well as other drugs to treat CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and follicle lymphoma note, in April this year, Zai Lab and Regeneron reached a strategic partnership on the development and commercialization of a CD20xCD3 double-specific antibody REGN1979 in Chinese mainland, Hong Kong, Taiwan and Macau agreement, Reding Pharma will pay a $30 million down payment to Regeneron, followed by a registration and sales milestone payment of up to $160 million Reding Pharma will share some of the global development costs of REGN1979 and will be granted exclusive rights to develop and commercialize in the field of oncology in Chinese mainland, Hong Kong, Taiwan and Macau early July, five clinical trial applications for REGN1979 were accepted by the National Drug Administration (NMPA) Drug Review Center (CDE) REGN1979 has been granted orphan drug qualification (ODD) by the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) REGN1979 is currently conducting a Phase I clinical study in patients with advanced FL, DLBCL and other lymphoma and a Phase II clinical study that may become a registered trial reGN1979 clinical Phase I studies positive data results were presented at the ASH2019 conference data show that REGN1979 single drug treatment recurrence or refractive diffuse large B cell lymphoma (R/R DLBCL), high doses showed increased efficacy: 5 out of 8 patients treated with 80/160/320mg achieved complete remission (CR), and 2 of the 3 patients who failed CAR-T treatment achieved CR !--/ewebeditor:!--:page:page title" - In addition, REGN1979 single drug treatment for recurrent or refractive follicular lymphoma (R/R FL) also showed increased efficacy with increased dose: 13 of the 14 patients treated with the treatment of 5 mg were remissioned, with a total remission rate (ORR) of 93% (n-13/14), and a total remission rate of 71.4% (N-10/14) () Original source: FDA grants://Therapy Therapy Therapy For Roche's CD20xCD3 bispecific cancer betatherapy mosunetuzumab it ditin foll lymphoma !--/ewebeditor: page.com.