New medicine for myeloma! Sanofi CD38 Antibody Sarclisa Combination Therapy Phase III Clinically Significantly Prolonged ProgressIon Survival, Deep Remission!
Last Update: 2020-06-17
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, June 10, 2020 /
BIOON/Sanofi has announced positive results from a clinical trial of CD38-targeted antibody drug Sarclisa (isatumab) for recurrent and/or refractable multiple myeloma (MM) PHASE III IKEMA
The results showed that the Sarclisa-Kafizomi-S-Kd programme significantly reduced the risk of disease progression or death by 47% and showed clinically significant depth remission (miniaturise-MRD)negative rate: 29.6% vsvsKd, compared to carfizomib, Kyprolis ®) and Kd)IKEMA (NCT03275285) is a randomized, multicenter, open-label Phase IIIclinical trialwith 302 patients with recurrent and/or refractive multiple myeloma (MM) in 69 clinical centers in 16 countries who have previously received 1-3 anti myeloma therapyDuring the trial, Sarclisa infusions through an intravenous infusion at a dose of 10 mg/kg, lasting four weeks per week, followed by a dose of 20/56 mg/m2, twice a week, using a standard dose of dexamethasone during treatmentThe main endpoint of the IKEMA trial is Progressless Survival (PFS)Secondary endpoints include total remission rate (ORR), good partial or better response (-VGPR), microresidual disease (MRD), full remission rate (CR), total lifetime (OS), and safetyon May 12 this year, Sanofi announced that the IKEMA trial had reached its primary end point in the first pre-planned mid-term analysis: the Sarclisa-Kafizomi-Dexametemison tridonomic sander (S-Kd) significantly increased PFS, the risk of disease progression or death, compared to the standard care option Kdthe detailed data released this time show that the risk of disease progression or death in the S-Kd group (n-179) decreased by 47% compared to the Kd group (n-123), (HR-0.531,99% CI:0.318-0.889, p-0.0007), and PFS significantly extended (medium PFS: not 19.15 months)Compared to Kd, the S-Kd scheme showed consistent therapeutic results in several subgroupssecondary endpoint: There was no statistically significant difference in ORR between the S-Kd group and kd group (86.6% vs 82.9% ;p .1930)The total mitigation rate (CR) in the S-Kd group was 39.7% and the Kd group was 27.6% The VGPR in the S-Kd group was 72.6% and the Kd group was 56.1% The total de-regime MRD-negative rate of MRD in the S-Kd group was 29.6% and the Kd group was 13%, indicating that nearly 30% of patients in the S-Kd group were able to detect multiple myeloma cells with next-generation sequencing at 1/100,000 sensitivity At the time of the mid-term analysis, the Total Lifetime (OS) data were not yet mature the study, Sarclisa's safety and tolerance were consistent with sarclisa's safety characteristics observed in other clinical trial , and no new safety signals were observed the results of the trial will be presented at the European Society of Hematology (EHA25) Virtual Congress on June 14 and will serve as a basis for filing a global regulatory application later this year "In the Stage III IKEMA trial, the S-Kd programme reduced the risk of disease progression or death by 47% compared to the Kd programme," said Philippe Moreau, M.D., Department of Hemalogy, University Hospital nantes, France These results show that Sarclisa has the potential to become a new standard for clinical treatment of recurrent multiple myeloma John Reed, M.D., head of research and development at Sanofi, said: "This is the second Phase III trial that demonstrates that Sarclisa is superior to standard care when added to a standard care solution These results further demonstrate the potential of this anti-CD38 monototagtoids to have a meaningful impact on patients We believe that Sarclisa has the potential to become the preferred anti-CD38 therapy for multiple myeloma We look forward to the results of future clinical trials to understand Sarclisa's impact in the early stages of the disease "
multiple myeloma (MM) is the second most common blood cancer, with more than 138,000 new diagnosed cases worldwide each year In Europe, 39,000 cases are diagnosed each year; Despite available treatments, MM remains an incurable malignant tumor associated with a severe burden on patients Since MM is incurable, most patients eventually relapse and there is no longer a therapeutic response to the treatmentcurrents currently available Sarclisa's active drug ingredient is an IgG1 encrusted monoclonal antibody that targets specific epitopes of plasma cell CD38 receptors and triggers a variety of unique mechanisms of action, including promoting procedural tumor cell death (apoptosis) and immunomodulatory activity CD38 is expressed at a high level on multiple myeloma (MM) cells and is a target for cell surface receptors for antibody therapy in MM and other malignant tumors In both the United States and the European Union, isatuximab has been granted the right to treat recurrent or refractive multiple myeloma (R/R MM) orphan sedatives Sanofi is also evaluating the potential of isitafishimab for the treatment of malignant tumors in other blood systems
and solid tumors in March, Sarclisa was awarded the U.S Fda approved, combined with pomemine and pom-dex, for adult PATIENTs with RRMM who have previously received at least two treatments, including indomine and protease inhibitors Earlier this month, Sarclisa's joint pom-dex proposal was also approved by the European Commission Sarcica received regulatory approval based on data from the Critical III ICARIA-MM study This is the first Phase III study to assess the positive results of Sarclisa's joint standard care regimen, and included patients with particularly difficult-to-treat and poor prognosis recurrence and refractive multiple myeloma (the median number of received anti myeloma therapies is 3), reflecting real-world clinical practice The results showed that in this category of patients, Sarclisa and pom-dex combined therapy significantly extended the survival of the disease inprogression (median PFS: 11.53 months vs 6.47 months), and the risk of disease progression or death was significantly reduced by 40% compared to standard care (Pomadomine plus dexametone, pom-dex) (HR.596;9 5% CI: 0.44-0.81; p-0.0010), significantly improved overall remission rate (ORR: 60.4% vs 35.3%, p 0.0001), and showed therapeutic benefits in all subgroups, including patients aged 75 years, patients with renal insufficiency, patients with renal insufficiency, patients with incurable treatment Sarclisa will be the first direct competitor to The Johnson and Johnson's blockbuster CD38-targeted drug Darzalex, which went on sale in 2015 and generated $2,998 million in global sales in 2019, up 48.0 percent from the previous year Analysts at Jefferies, a Wall Street investment bank, expect Sarcisa's annual sales peak to exceed $1bn currently, Sanofi is advancing a number of Phase III clinical studies to evaluate isatuximab in combination with currently available standard therapies for the treatment of RRMM patients or mm patients with new diagnosis MM is the second most common type of malignant tumor in the blood system, with more than 1.38 million people suffering each year worldwide For most patients, MM is still incurable, so there are significant unmet medical needs in this area (BioValleyBioon.com) original source: Sarclisa? (isatuximab) therapy therapy therapy sydd cesion free y clinically sylweddol fod yn patients with relapsed multiple myeloma
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