The world's first BCMA targeted therapy! GlaxoSmithKline Blenrep (belantamab mafodotin) is about to be approved for listing in the US and Europe!

!--webeditor: "page title" - / GSK recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review of the approval of Blenrep (belantamab madotfoin, GSK2857916), the drug is the drug An antibody drug coupling (ADC) that targets B-cell maturation antigens (BCMA) for adult patients who have previously received at least 4 therapies and whose disease has previously received at least one protease inhibitor, an immunomodulator, an anti-CD38 antibody, and multiple myeloma (MM) that has been confirmed to progress 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 edits greater than its risk, and supported approval of the drug: as a monodrug therapy for patients who have previously received at least four treatments, including an immunomodulator, a protease inhibitor, an anti-CD38 antibody, recurrent or refractory multiple-disease (MM) patients.
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.
is currently under going under fda review by the FDA and accelerated assessment by the EUROPEAN Union's 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,
, 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, showing that the belantamam mafodotin (2.5mg/kg, once every 3 weeks) of single-drug treatment is 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). No new safety signals were found during
long follow-up.
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:) !--/ewebeditor: !---!--ewebeditor: page:page:page title" - DREAMM clinical development project s a total of 10 clinical studies (DREAMM-1 to DREAMM-10), is being evaluated as a single drug therapy and the efficacy of combination therapy first, second and multi-mm therapy.
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 and 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 lysatime (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, it confirms that the potential of belantamab mafodotin combination therapy in patients with multiple myeloma in patients with multiple myeloma is the second most common hematologic malignant tumor after non-Hodgkin lymphoma in the research MM immunotherapy (source literature - PMID: 31277554).
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, and has become a very popular immunotherapy target for mm and other blood system malignancies in recent years.
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) that is a combination of a non-lysate link (drug link technology licensed from Seattle Genetics) a DDC 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.
() Original origin: GSK receivings positive CHMP opinion ceed difod of belantamab mafodotin for the treatment of the treatment of relapsed and rheeny multiple myeloma !--/ewebeditor.