The world's first BCMA targeted therapy! GlaxoSmithKline Blenrep will soon be approved for listing in the U.S. and Europe

GlaxoSmithKline (GSK) recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review recommending approval of Blenrep (belantamab mafodotin, GSK2857916), a target B-cell maturation antigen (BCMA) Antibody drug conjugate (ADC) for: as a monodrug therapy, for the treatment of patients with multiple myeloma (MM) who have previously received at least 4 therapies and whose disease is resistant to at least one protease inhibitor, an immunomodulator, an anti-CD38 antibody, and is confirmed to be progressing during the last treatment.now, CHMP's positive comments will now be reviewed by the European Commission (EC), which usually makes a final review decision within two months.in U.S. regulation, the FDA's Advisory Committee on Oncology drugs (ODAC) voted 12-0 in the middle of this month to argue that the clinical benefits of belantamab mafodotin outweigh editing its risk, in favor of approval of the drug: as a monodrug therapy, for the treatment of patients who have previously received at least four treatments, including an immunomodulator, a protease inhibitor, an anti-CD38 antibody, recurrent or refractory multiple-disease marrowoma (MM).notable, prior to the ODAC meeting, FDA internal examiners expressed concern about eye-related adverse events.FDA will consider the ODAC's recommendations when making a final review decision, although they are not binding.currently, Belantamab mafodotin is under priority review by the FDA and accelerated assessment by the EUROPEAN Union EMA.if approved, the drug would be the first BCMA-targeted therapy to go on the market.in 2017, belantamab mafodotin was awarded the U.S. FDA Breakthrough Drug Qualification (BTD) and the European Union EMA-granted Priority Drug (PRIME), the first BCMA-targeted formulation to be awarded BTD and PRIME.these qualifications are designed to facilitate the development of research-in-the-drug drugs with clinical prospects in areas where significant unmet medical needs are met. Dr Axel Hoos, senior vice president and head of oncology research and development at glaxoSmithKline at, said: "Today's positive review by CHMP is an important step in helping patients with recurrent or refractive multiple myeloma who have limited choices and poor prognosis., if approved, belantamab mafodotin will provide patients and doctors in Europe with a pioneering anti-BCMA therapy that has a different mechanism than other therapies currently available."CHMP's positive opinion, based on data from the DREAMM Clinical Trials Project, including key DREAMM-2 studies.this is a randomized, open-label, bi-arms PHASE II study that included 196 patients with former overtreated (heavily pretreated) R/R MM patients whose condition worsened despite current standard treatment, the median treatment treatment received in the past was 7, the immunomodulatory drugs and protease inhibitors were difficult to treat, and the treatment of CD38 antibodies was difficult to treat and/or not tolerated.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 weeks.the preliminary results of the six-month study, published in The Lancet Oncology in December 2019, as the basis for regulatory filings in the United States and Europe.at 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 the belanab mafodotin (2.5mg/kg, once every 3 weeks) of single-drug treatment was in the middle of the The duration of mitigation (DoR) was 11 months (95% CI: 4.2 -not reached), the median total lifetime (OS) was 14.9 months (95% CI: 9.9-not reached), orR data was consistent with the 6 months data (ORR s 32%).in these patients, the majority (58%) of the patients achieved very good partial or better remission (-VGPR), including 2 strict total remission (sCR) and 5 cases of total remission (CR). The proportion of patients who benefited clinically was 36% (95% CI: 26.6-46.5). a long follow-up visit, no new safety signals were found. the most common adverse events of level 3 or higher (in patients with more than 10% of the population) were corneal lesions/microcystic epithelial changes (MEC; 46%), platelet reduction (22%), anemia (21%), decreased lymphocyte count (13%) and neutrophil smaller (11%). the first case of corneal lesions (MEC) is characterized by changes in corneal epithelial cells seen in the eye examination, which can appear or not develop symptoms. at the time of the data cut-off, 77% of patients in the 2.5 mg/kg dose group were treated and there have been no reports of permanent vision loss to date. for R/R MM patients who receive currently available treatments but the disease is still progressing, treatment options are very limited and the prognosis is poor. the latest results from the DREAMM-2 study are further evidence of the potential of belantamab mafodotin. if approved, belantamab mafodotin will provide these patients with an important new treatment option to help address significant unmet medical needs. belantamab mafodotin (picture source: DOI:) DREAMM clinical development project sits on 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 treatmentmmmms. previously 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 patients. at the ASCO annual meeting, GSK also released data from the DREAMM-6 study. the 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 bortimizomi /Seemison (BorDex). preliminary results show that the total remission rate (ORR) of belantamab mafodotin in conjunction with BorDex (B-Vd) treatment reached 78% (n?14/18; 95% CI: 52.4-93.6), 50% was very good partial remission (VGPR), and 28% was partial lying (PR). The proportion of patients clinically beneficial (minimal remission or better) was 83% (95% CI: 58.6-96.4). median treatment at 18.2 weeks, the median DoR has not yet been reached. adverse events level 3 or above included corneal lesions (MEC; 56%) and platelet reduction (61%). there are no level 4 MEC cases in . these preliminary results, confirming the potential of belantamab mafodotin combination therapy in patients with early stages of multiple myeloma, BCMA is the second most common hematoma in the study of MM immunotherapy (source literature - PMID: 31277554) multiple myeloma (MM) after non-Hodgkin lymphoma. in recent years, although much progress has been made in chemotherapy, protease inhibitors, immunomodulator thalidomide derivatives and CD38 targeted antibodies, almost all patients will eventually relapse. therefore, there is an urgent need for new treatment options. MM market is close to $14 billion in 2017 and is expected to reach nearly $29 billion by 2027. BCMA is an extremely important B-cell biomarker, widely found on the surface of MM cells, in recent years has become MM and other blood system malignancies a very popular immunotherapy target. currently, there are more than 20 immunotherapy types 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, GlaxoSmithKline for rep). belantamab mafodotin is a new type of human-derived Fc-modified anti-BCMA monoantigen and cytotoxic agent MMAF (monomethyl auristatin-F) a combination of a non-lysate link (drug link technology licensed from Seattle Genetics) ADC drug. belantamab mafodotin binds to BCMA on the surface of mm cells with anti-BCMA mono-anti-target, and is then rapidly internalized by MM cells, degraded in the lysosome and released in MM cells with non-permeable MMAF. 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 G/M and induces caspase-3-dependent cell apoptosis. in addition, belantamab mafodotin can induce NK cell-mediated ADCC (the cytotoxic action of antibody-dependent cell-mediated) and macrophage mediated ADCP (antibody-dependent cell-mediated phagocytopha. 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 currently in clinical development for the treatment of patients with r/R MM and other patients with advanced hemosomes expressing BCMA. .