New myeloma drug! Sanofi CD38 Antibody Sarclisa Phase II Phase II trial pre-empts Johnson and Johnson's $3 billion drug Darzalex

2020 May 13 News /BioValleyBIOON / - Sanofi (Sanofi) today announced that assess CD38 targeting antibody drug Sarclisa (isatuximab) treatment IKEMAa recurrence of clinical trials and / or refractory multiple myeloma (MM) phase III achieved positive resultsIKEMA (NCT03275285) was a randomized, multicenter, open-labelIII clinical trial of a, in 69 clinical centers in 16 countries enrolled 302 patients with recurrent and / or difficult to treatment of multiple myeloma (MM) patients, the patients previously treated with one to three anti-myeloma therapyDuring the test, Sarclisa by intravenous infusion at a dose of 10mg / kg, once weekly for four weeks, then every infusion once a week carfilzomib dose is 20 / 56mg / m2 twice a week, using standard dose during treatment dexamethasoneThe primary endpoint IKEMA trial is progression-free survival (PFS)Secondary endpoints included overall response rate (ORR), a very good partial response or better reaction (≥VGPR), minimal residual disease (MRD), complete remission (CR), overall survival (OS) and safetyresults show that in the first interim analysis preplanned, the test has reached the primary endpointThe recommendation of the Independent Data Monitoring Committee (IDMC), which results in advance announced: the standard of care program carfilzomib (carfilzomib, Kyprolis®) + dexamethasone compared, Sarclisa + dexamethasone + carfilzomib three drugs program will be progression-free survival (PFS) was significantly longer, the risk of disease progression or death was significantly reduced, the test found no new safety signalsthe test results will be published onmedical upcoming meeting, and submit regulatory submissions as a basis for later this yearSanofi head of global R & D, MD JohnReed expressed: "
the phase III clinical trials, add Sarclisa to carfilzomib and dexamethasone standard care regimen, the results clearly show the risk of disease progression or death was significantly reduced this is the second positive phase III trial Sarclisa further support the potential of our drugs improve patients relapsed multiple myeloma prognosis "
multiple myeloma (MM ) is the second most common blood cancer in the world each year new diagnosis cases more than 138,000 cases In Europe, 39,000 cases diagnosed each year; in the United States, 32,000 cases diagnosed each year Despite available treatments, MM remains a malignant tumor an incurable, associated with severe burden on the patient Since the MM can not be cured, most patients eventually relapse, for there are no currently available therapy treatment response The active pharmaceutical ingredient Sarclisa isatuximab a IgG1 chimeric monoclonal antibody specific epitope targeted plasma cells CD38 receptor, it can trigger a variety of unique mechanism of action, including the promotion of programmed tumor cell death (withered death) and immunomodulatory activities CD38 was expressed at high levels in multiple myeloma (MM) cells, and other malignancies of MM cell surface receptor targets for antibody therapy In the United States and the European Union, isatuximab were granted the treatment of relapsed or refractory multiple myeloma (R / RMM) orphan drug status Currently, Sanofi also being evaluated isatuximab therapeutic potential malignant tumor other solid tumors and blood system a March, Sarclisa approved by the US FDA , horse joint poise lenalidomide and dexamethasone (pom-dex), to have received at least two previous therapies (comprising lenalidomide and proteasome inhibitor) RRMM adult patients The end of March this year, Sarclisa joint pom-dex program is also approved by the European Medicines Agency (EMA) positive opinion Committee for Medicinal Products for human use (CHMP) recommended approval of the European Commission (EC) is expected to make a final review of the decision in May Sarclisa regulatory approval, based on a pivotal Phase III study data ICARIA-MM This assessment is the first phase III study in combination with standard care regimens Sarclisa get a positive result, the group particularly difficult to treat and the prognosis is very poor relapsed and refractory multiple myeloma patients (median accepted anti-myeloma therapy for the three kinds), reflecting the real-world clinical practice The results showed that, in such patients, compared with standard of care (Park horse lenalidomide + dexamethasone, pom-dex), Sarclisa with pom-dex combination therapy will be progression-free survival was significantly longer (median PFS: 11.53 months vs6.47 months), the risk of disease progression or death was significantly reduced 40% (HR = 0.596; 95% CI: 0.44-0.81; p = 0.0010), significantly increased overall response rate (ORR: 60.4% vs35.3% , p <0.0001), and in various subgroups have shown therapeutic benefit, including age ≥75 years of age, patients with renal insufficiency, in patients refractory to lenalidomide Sarclisa will become listed Johnson & Johnson blockbuster CD38 targeted drugs Darzalex first direct competitor, which is listed on the 2015, 2019 global sales of $ 2.998 billion, up 48.0% over the previous year, an increase of Wall Street investment bank Jefferies analyst expects peak annual sales of Sarclisa after the listing will exceed $ 1 billion Currently, Sanofi is advancing a number of Phase III clinical study to evaluate the joint standard therapy isatuximab currently available for the treatment of MM patients or patients with a new diagnosis RRMM of MM is the most common malignant tumor second blood system, on a global scale, the number of patients each year more than 1.38 million For most patients, MM remains incurable, so that there is a significant area of ​​unmet medical needs (Biovalley Bioon.com) ORIGINAL: Sarclisa (isatuximab) Phase3IKEMAtrialmeetsprimaryendpointearlyinpatientswithrelapsedmultiplemyeloma