The world's first BCMA targeted therapy! GSK Antibody Drug Coupling Belantamab Mafodotin was approved by the FDA Committee in full!

!--webeditor:page title"--/ GlaxoSmithKline (GSK) recently announced that the U.SFood and Drug Administration (FDA) Advisory Committee on Oncology Drugs (ODAC) voted 12-0 to support the clinical benefits of belantamab mafodotin (GSK2857916) Greater than its risk: The drug is an antibody drug conjugate (ADC) that targets B-cell maturation antigens (BCMA) and is used as a single drug therapy to treat patients with recurrent or refractory multiple myeloma (MM) who have previously received at least four treatments, including an immunomodulator, a protease inhibitor, and an anti-CD38 antibodyTwo members of the committee were unable to take part in the final voteNotably, prior to the ODAC meeting, FDA internal examiners expressed concern about eye-related adverse eventsThe FDA will consider the ODAC's recommendations when making a final review decision, although they are not bindingCurrently, belantamab mafodotin is under going under fda review and accelerated assessment by the EUROPEAN Union's EMAIf approved, the drug would be the first BCMA targeted therapy to be availableIn 2017, belantamab mafodotin was awarded the U.SFDA Breakthrough Drug Qualification (BTD) and the European Union EMA-granted Priority Drug (PRIME), the first BCMA-targeted formulation to be awarded BTD and PRIMEThese qualifications are designed to facilitate the development of research drugs with clinical prospects in areas of significant unmet medical needsDr Axel Hoos, Senior Vice President and Director of Oncology Research and Development at GlaxoSmithKline, said, "We are pleased that the Committee recognizes the potential of belantamab mafodotin to help patients with recurrent or refractable multiple myeloma, an incurable disease with limited treatmentWe look forward to working with the FDA to complete the review of the pharmaceutical biologics licensing application"The ODAC full vote supports the recommendations, based on data from the DREAMM clinical trial project, including key DREAMM-2 studiesThis is a randomized, open-label, two-arm phase II study that included 196 patients with previous overtreatment (heavily pretreated) R/R MM patients whose condition worsened despite current standard treatment, with a median treatment of 7 previous treatments, difficult to treat immunomodulatory drugs and protease inhibitors, and resistance to CD38 antibodies and/or intoleranceIn the study, patients were randomly divided into two groups and treated at 2.5 mg/kg or 3.4 mg/kg dose belantamab mafodotin every three weeksThe preliminary results of the six-month study were published in The Lancet Oncology in December 2019 and serve as the basis for regulatory filings in the United States and EuropeAt the end of May this year, GSK presented the study's 13-month follow-up data at the 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting, which showed that belantamab mafodotin (2.5mg/kg, every 3 weeks) W) Median remission duration (DoR) for single drug therapy was 11 months (95% CI: 4.2 - not reached), and median total lifetime (OS) was 14.9 months (95% CI:9.9 - not reached)The ORR data are consistent with the six-month data (ORR-32%)Of these patients, the majority (58%) achieved very good partial or better remission (-VGPR), including 2 strict full remission (sCR) and 5 cases of total remission (CR)The proportion of patients who benefited clinically was 36% (95% CI: 26.6-46.5)No new safety signals were found during the long follow-upAmong patients receiving a dose of 2.5 mg/kg, the most common adverse events of level 3 or higher (occurring in patients with more than 10 per cent) were corneal lesions/microcystic epithelial changes (MEC; 46 per cent), platelet reduction (22 per cent), anemia (21%), decreased lymphocyte count (13%) and neutrophils decrease (11%)The first case of corneal lesions (MEC) is characterized by changes in corneal epithelial cells seen by eye examination, which can appear or not develop symptomsAt the time of the data cut-off, 77% of patients in the 2.5 mg/kg dose group were treated and no permanent vision loss has been reported to dateFor R/R MM patients who receive currently available treatments but the disease is still progressing, treatment options are very limited and the prognosis is poorThe latest results from the DREAMM-2 study are further evidence of the potential of belantamab mafodotinIf approved, belantamab mafodotin will provide these patients with an important new treatment option to help address significant unmet medical needsThe Belantamab mafodotin mechanism of action (Photo: DOI:) DreamM clinical development project consists of 10 clinical studies (DREAMM-1 to DREAMM-10) and is evaluating the efficacy and safety of belantamab mafodotin as a monodrug therapy and for combination therapy first- and second-line treatment mmPreviously released updated data from DREAMM-1, the first human clinical study, showed that the total remission rate (ORR) of belantamab mafodotin therapy reached 60% in BCMA-positive R/R MM patientsAt the ASCO annual meeting, GSK also presented data from the DREAMM-6 studyThe study was conducted in R/R MM patients who had relapsed after one or more treatments were difficult to treat, and investigated the efficacy and safety of belantamab mafodotin (2.5 mg/kg, once every 3 weeks ( Q3W) in combination with boratizom / Dexamex (BorDex)!--/ewebeditor:!--webeditor:page title"--Preliminary results show that the total remission rate (ORR) of belantamab mafodotin combined bordex (B-Vd) treatment reached 78% (n?14/18; 95% CI: 52.4-93.6), 50% is a very good partial relief (VGPr), 28% The proportion of patients who received clinical benefits (minimum remission or better) was 83% (95% CI: 58.6-96.4)At 18.2 weeks of median treatment, the median DoR has not yet been reached Adverse events of level 3 or above included corneal lesions (MEC; 56%) and platelet reduction (61%) No level 4 MEC cases These preliminary results confirm that belantamab mafodotin combined therapy has the potential BCMA as a target in patients with multiple myeloma in the study of MM immunotherapy (source literature - PMID: 3127554) multiple myeloma (MM) is the second most common hematoma after non-Hodgkin lymphoma Although much progress has been made in recent years in chemotherapy, protease inhibitors, immunomodulator thalidomide derivatives and CD38-targeted antibodies, almost all patients will eventually relapse As a result, there is an urgent need for new treatment options The MM market is close to $14 billion in 2017 and is expected to reach nearly $29 billion in 2027 BCMA is an extremely important B-cell biomarker, widely found on the surface of MM cells, and has become a very popular immunotherapy target for MM and other hematologic malignancies in recent years Currently, there are more than 20 immunotherapy sexists developed for BCMA, mainly divided into three categories: chimeric antigen receptor T-cell therapy (CAR-T, new base/bluebird biology, Nohuawei representative), bispecific antibodies (BsAb, amgen for the representative), antibody drug conjugate (ADC, GSK as representative) Belantamab mafodotin is a new human-derived Fc-modified anti-BCMA monoantigen and cytotoxic agent MMAF (monomethyl auristatin-F) a combination of a non-lysis link (drug link technology licensed from Seattle Genetics) ADC drug Belantamab mafodotin binds to BCMA on the surface of mm cells by anti-BCMA mono-anti-target, and is then rapidly internalized by MM cells, dedegradings in the lysosome and releases non-permeable MMAF in MM cells MMAF is a filament-splitting inhibitor that is an anti-microtube protein compound that inhibits cell division by blocking microtube polymerization, stops tumor cells in The G/M stage and induces caspase-3-dependent cell apoptosis In addition, belantamab mafodotin can induce NK cell-mediated ADCC (the cytotoxic effect of antibody-dependent cell-mediated) and induced macrophage-mediated ADCP (antibody-dependent cell-mediated phagocytopharycal action) Belantamab mafodotin selectively acts on MM cells through a variety of cytotoxic mechanisms, promising to provide potential next-generation immunotherapy options for this type of cancer Currently, belantamab mafodotin is being clinically developed for the treatment of patients with R/R MM and other patients with advanced hemosomes expressing BCMA () Original source: GSK announces FDA advisory committee votes in favour of positive benefit/risk for belantamab mafodotin for patients relapsed/turnory multiple myeloma !--/ewebeditor: page.