The world's first BCMA targeted therapy! GlaxoSmithKline Brenrep is approved by the European Union to treat relapse/recurring multiple myeloma!

http!--s webeditor: page.title-- August 28, 2020 / -- GlaxoSmithKline (GSK) recently announced that the European Commission (EC) has conditionally approved Blenrep (belantamab mafodotin, GSK2857916), a target B-cell mature antigen (BCMA) Antibody drug association (ADC), the adaptive disorder is: as a single drug therapy, used to treat adult patients who have previously received at least 4 therapies and whose disease is resistant to at least one protease inhibitor/an immunomodulant/a CD38 mono-resistant, recurring or refractic multiple myeloma (R/R MM) that has been shown to progress in the last treatment.
early August, Blenrep obtained accelerated FDA approval through a priority review process.
based on tumor mitigation data, the adaptive disorder is approved through an accelerated approval process.
approval of the adaptation will depend on the validation and description of the clinical benefits in the validation trial.
It's worth noting that Blenrep is the world's first approved BCMA targeted therapy, the first humanized anti-BCMA therapy for patients who receive current standard care but are progressing.
Blenrep uses a multi-role mechanism to target BCMA, a cell surface protein that plays an important role in plasma cell survival and is expressed in multiple myeloma cells.
Despite advances in clinical treatment, multiple myeloma (MM) remains an incurable and devastating disease, and patients continue to face cycle therapy, with each recurrence leading to worsening prognosis.
Blenrep is the world's first approved anti-BCMA therapy, with a new mechanism of action that represents a new treatment that can be turned to Brainrep when patients stop responding to other standard therapies, which has the potential to transform the clinical treatment of patients with limited current options for relapse or refractive myeloma.
in the United States and the European Union, Blenrep was awarded breakthrough drug eligibility (BTD) and priority drug qualification (PRIME), respectively, and was the first BCMA targeted agent to be awarded BTD and PRIME.
Hal Barron, Chief Scientific Officer and President of Research and Development at GlaxoSmithKline, said: "Blenrep's approval marks an important step forward for patients in Europe, which diagnoses nearly 50,000 multiple myelomas each year.
Unfortunately, most of these patients will relapse or stop responding to existing therapies, so I am pleased that today's news will enable patients with limited treatment options to obtain the first approved anti-BCMA therapy.
" approval, based on data from the critical DRAMM-2 study, including 13 months of follow-up data.
This is a randomized, open-label, two-arm Phase II study that included 196 patients with past overtreatment (heavily pretreated) R/R MM whose condition worsened despite current standard treatments, had a median of 7 treatment options, were difficult to treat with immunomodulation drugs and protease inhibitors, and were resistant to CD38 antibodies and/or insuperance.
study, patients were randomly divided into two groups and treated with a dose of Blenrep every three weeks (Q3W) of 2.5 mg/kg or 3.4 mg/kg.
study data show that the total remission rate (ORR) of Blenrep 2.5mg/kg Q3W single drug therapy was 32%, the medium duration of remission (DoR) was 11 months, and the total survival of the medium (OS) was 13.7 months.
security and tolerance are consistent with previously reported Blenderp data.
most common adverse reactions in the 2.5mg/kg group were corneal lesions/microcystic epithelitis (MEC; 71%), plate plate plate reduction (38%), anemia (27%), vision Fuzzy events (25%), nausea (25%), fever (23%), elevation of acetaminophen (AST) (21%), infusion-related reactions (21%), lymphocytic cell reduction (20%).
treatment options are very limited and the prognostics are poor for patients with R/R MM who receive standard care therapy currently available but the disease is still progressing.
follow-up results from the DRAMM-2 study further demonstrate The potential of Brenrep.
approval of the drug will provide these patients with an important new treatment option to help address significant unsealed medical needs.
10 clinical studies (DREAMM-1 to DREAMM-10) are being evaluated for the efficacy and safety of Brenrep as a monotherapy and for combination therapy first-, second-line and multi-line therapy MM.
previously released from the first human clinical study, DRIAMM-1, showed that in BCMA-positive R/R MM patients, the total remission rate (ORR) of Blenrep therapy reached 60%.
data from the DRAMM-6 study at the annual meeting of the American Society of Clinical Oncology (ASCO) in late May.
the study was conducted in patients with R/R MM who had relapsed after treatment with one or more therapies, the efficacy and safety of Blenrep (2.5mg/kg, Q3W) combined borontzomi/BorDex.
results show that the total remission rate (ORR) of Blenrep combined BorDex (B-Vd) therapy reached 78% (n=14/18; 95% CI: 52.4-93.6), 50% was very good partial remission (VGPR), and 28% was partial remission (PR).
patients who received clinical benefits (minimum remission or better) were 83% (95% CI: 58.6-96.4).
18.2 weeks of treatment, the medium DoR had not yet been reached.
level 3 or above include corneal lesions (MEC; 56%) and plate plate plate reduction (61%).
no level 4 MEC cases.
these preliminary results confirm the potential of Brainrep combined therapy in patients with early stages of multiple myeloma !--/ewebeditor:page--!--ewebeditor:page title""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""-- BCMA is the second most common hematological malignancy after non-Hodgkin's lymphoma in the study of MM immunotherapy (source literature - PMID: 31277554) multiple myeloma (MM).
recent years, despite significant advances in chemotherapy, protease inhibitors, immunomodulant salidamine derivatives and CD38 targeted antibodies, almost all patients eventually relapse.
, 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 in 2027.
BCMA is an extremely important biomarker of B cells, 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 immunotherapies developed for BCMA, mainly divided into three categories: chime antigen-subject T-cell therapy (CAR-T, Bacsinszky/Bluebird Bio, Novarma representative), dual-specific antibodies (BsAb, represented by Amgen), antibody drug couples (ADC, represented by GlaxoSmithKline).
Blenrep is a new humanized Fc-modified anti-BCMA monoantigen and cytotoxic agent MMAF (monomethyl auristatin-F) aDC drug that is coupled with a non-lysed linker (the drug link technology is licensed from Seattle Genetics).
Blenrep works by anti-BCMA monoantitor target binding to BCMA on the surface of MM cells, which is then rapidly internalized by MM cells, degraded in lysosomes and released in MM cells.
MMAF is a silky division inhibitor, an anti-micro-tube protein compound that inhibits cell division by blocking micro-tube polymerization, stops tumor cells in G/M and induces apoptosis on which caspase-3 depends.
In addition, Blenrep induces NK cell-mediated ADCC (antibody-dependent cell-mediated cytotoxicity) and macrophage-mediated ADCP (antibody-dependent cell-mediated phagocytospheric).
Blenrep selectively acts on MM cells through a variety of cytotoxic mechanisms, providing a promising next-generation immunotherapy option for this type of cancer.
, Blenrep is also being developed for other patients with advanced blood system malignancies that express BCMA.
() Original source: European Commission approves BLENREP (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma !--/ewebeditor:page--.