The world's first BCMA targeted therapy! GSK announces new data from the Belantamab mafodotin myeloma project: 78% of the total remission rate for early treatment!

May 29, 2020 /
BiovalleyBIOON/ --GlaxoSmithKline(GSK) recently released the latest data on the DREAMM clinical program, further highlighting the potential of belantamab mafodotin (GSK2857916) as a single-drug therapy and combination therapy for recurrent/difficult multiple myeloma (R/MM)belantamab mafodotin, an antibody drug conjugal (ADC) that targets B-cell mature antigens (BCMA), is currently undergoingThe FDA's priority review and the EU EMA's accelerated evaluation of the drug applied for treatment for R/R MM patients who have previously received a variety of therapies, including an immunomodulator, an protease inhibitor, and an anti-CD38 antibodybelantamab mafodotin has the potential to become the first anti-BCMA therapy on the marketIn 2017, belantamab mafodotin was awarded the Breakthrough Drug Qualification (BTD) by the U.SFDAand the EUROPEAN Union EMA Priority Drug Qualification (PRIME), becoming the first targeted formulation to be awarded to BTD and PRIMEBCMAThese qualifications are designed to facilitate the development of in-research drugs with clinical prospects in areas where significant medical needs are not metbelantamab mafodotin's regulatory filings in the United States and the European Union are based on data from the DREAMM-2 studyThis randomized, open-label, two-arm Phase II study included 196 patients with past over-treatment of over-treatment R/R MM patients who, despite current standard treatments, deteriorated their condition, received a median treatment of 7 previous treatment strains, was difficult to treat immunomodulating drugs and protease inhibitors, and were difficult to treat and/or tolerated against CD38 antibodiesIn the study, patients were randomly divided into two groups and treated with a dose of 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks data from the 13-month follow-up from the DREAMM-2 study showed that the median remission duration (DoR) of the
belantamab mafodotin (2.5 mg/kg, Q3W) single-drug treatment was 11 months (95% CI: 4.2-not), and the total survival of the (OS) was 14.9 months
(95.9%: 9.9.9.9 THE ORR data is consistent with the 6-month data (ORR-32%) In these patients, the majority (58%) had very good partial or better remission ( VGPR), including 2 cases of strict total remission (sCR) and 5 cases of complete remission (CR) The proportion of patients receiving clinical benefits was 36% (95% CI: 26.6-46.5) long follow-up, no new safety signals were found The most common level 3 or higher adverse events (in patients with more than 10% of patients) were keraque lesions/microcystic epithelial changes (MEC;46%), platelet reduction (22%), anemia
(21%), lymphocytic count decline (13%) and neutrophil stolicion (11%) The first case of corneal lesions (MEC) is characterized by changes in corneal epithelial cells seen during eye examinations, which can or may not show symptoms At the data cut-off, 77% of patients in the 2.5 mg/kg dose group were resolved, and no permanent vision loss has been reported to date have limited treatment options and poor prognosis for R/R MM patients who are currently receiving treatment sweathing but whose disease is still progressing Data from the DREAMM-2 study show that, if approved, belantamab mafodotin will provide these patients with an important new treatment option Dr Axel Hoos, senior vice president and head of oncology
research and development at GlaxoSmithKline , said: "The latest results from the DREAMM-2 study published at ASCO are further evidence of the potential of belantamab mafodotin to address significant unmet needs in patients who continue to progress despite treatment options We are working hard to bring belantamab mafodotin to patients with this invasive disease, and we are very encouraged by these new data "
another DREAMM-6 study, conducted in R/R MM patients whose condition recurs after receiving one or more therapies, investigated the efficacy and safety of belantamab mafodotin (2.5 mg/kg, every 3 weeks) in combination with Bordami/BorDmison." preliminary results from the study showed that the total remission rate (ORR) of the belantamab mafodotin combined 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 remission (PR) The proportion of patients receiving clinical benefits (minimum remission or better) was 83% (95% CI: 58.6-96.4) At 18.2 weeks of median treatment, the median DoR had not yet reached adverse events level 3 or above include keracorn lesions (MEC; 56%) and platelet reduction (61%) There are no level 4 MEC cases "We are encouraged by the initial results of the DREAMM-6 study that confirm the potential of the belantamab mafodotin combination therapy in early stage patients with multiple myeloma," said , Dr Axel Hoos Once complete data is available, it will be shared with the scientific community as soon as it is available "
belantamab mafodotin mechanism (Image: DOI: https://doi.org/10.1016/S1470-2045 (19) 30788-0 DREAMM Clinical Development Program, which includes 10 clinical studies (DREAMM-1 to DREAMM-10), is evaluating the efficacy and safety of belantamab mafodotin as a single-drug therapy and for first-, second- and multi-line therapies Updated data from the first human clinical study, DREAMM-1, previously published, showed that the total remission rate (ORR) for belantamab mafodotin treatment reached 60% in patients with BCMA-positive R/R MM multiple myeloma (MM) is the second most common hematological malignant tumor after non-Hodgkin's lymphoma In recent years, almost all patients have eventually relapsed, despite significant progress in chemotherapy, protease inhibitors, immunomodulator thalidomide derivatives, and CD38 targeted antibodies Therefore, 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, in recent years has become MM and other blood systems malignant tumor a very popular immunotherapy target Currently, more than 20 immunotherapies are developed for BCMA, mainly divided into three categories: chimeric antigen receptor T-cell therapy (CAR-T, neo-base/bluebird biology, Novartis ), bispecific antibodies (BsAb, Amgen as representative), antibody drug conjugate (ADC, GlaxoTech as representative) belantamab mafodotin is a new type of humanized Fc-modified anti-BCMA monoantigen with cytotoxic agent MMAF (monomethyl auristatin-F) that is a non-cracking link (drug link technology is licensed from Seattle genetic ) Belantamab mafodotin works by binding BCMA to BCMA on the surface of the MM cell by anti-BCMA monoantigen, which is then rapidly internalized by MM cells, degrading in the lysosome and releasing a non-permeable MMAF in the MM cell MMAF is a filamentized inhibitor, an anti-microtubule protein compound that inhibits cell division by blocking microtubule polymerization, which can stop tumor cells in the G/M stage and induce caspase-3-dependent apoptosis In addition, belantamab mafodotin induces NK cell-mediated ADCC (antibody-dependent cell-mediated cytotoxic action) and macrophages-mediated ADCP (antibody-dependent cell-mediated phagocytosis) belantamab mafodotin selectively acts on MM cells through a variety of cytotoxic mechanisms and is expected to offer potential next-generation immunotherapy options for these types of cancers Currently, belantamab mafodotin is being clinically developed for the treatment of patients with malignant tumors of the advanced blood system of R/R MM and other advanced blood systems that express BCMA (BioValleyBioon.com) original source: DREAMM-2 and DREAMM-6 data at ASCO reinforce the situ of GSK's s s i'r belantamab mafodotin in patients in patients relapsed/refractory multipleelo myma