Nordson Jianhua publishes the latest clinical data on Ebtini

On December 7th, Novarma released the latest clinical data on bruton tyrosine kinase (BTK) inhibitor Abteni at the 62nd annual meeting of the American Society of Hematology (ASH).
In two clinical studies for relapsed/recurring sleeve lymphoma (MCL) and recurring/resuscable chronic lymphoblastic leukemia (CLL)/small cell leukemia (SLL), ebutinib showed good overall remission and safety.
Updated data from the Recurring/Resuscable Chronic Lymphocytic Leukemia/Small Lymphocyte Lymphoma Chinese Patient Phase II Study: This study was conducted in patients with recurring/resuscable chronic lymphoblastic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) to assess the efficacy and safety of oral ebtoninib.
end point of a clinical trial is total mitigation rate (ORR), and secondary endpoints include mitigation duration (DOR), progress-free lifetime (PFS), and safety.
80 patients were admitted to the study, most of whom were in the advanced stages of the disease, with a medium follow-up time of 14.3 months.
IRC assessed the total mitigation rate of ORR at 91.3 per cent, of which the total remission rate (CR) was 10.0 per cent, the partial mitigation rate was 63.8 per cent and the partial remission rate with lymphocyte growth was 17.5 per cent.
1.87 months from the mid-level, neither the mid-PFS and the DOR were reached.
most adverse events are mild to moderate, and time-extended follow-up analysis does not find new security issues.
common adverse events (AEs) of any cause/grade include plate reduction, neutral granulocyte reduction, anemia, upper respiratory tract infections, pneumonia, and hypokalemia.
Long-term safety and stability of patients with relapsed/refractic heterocytic lymphoma treated with absine monotherapy: a multi-center, open, clinical Phase II study: The main objectives of this study in patients with relapsed/refractic heterocyctic lymphoma (R/R MCL) were effectiveness and safety, and the main endpoints of clinical trials were total remission rate (ORR), secondary endpoints including remission duration (DOR), progressive survival (DOR) and safety.
106 patients in this study, with a medium follow-up time of 16.4 months, most of whom were in the advanced stages of the disease.
the Lugano Standard (2014), the overall remission rate was 87.9 per cent and 93.9 per cent of patients achieved disease control.
based on CT imaging method, the total remission rate (CR) reached 34.3%.
DOR and PFS are not reached.
efficacy and safety in treating patients with R/R MCL.
adverse events include plateia, neutral granulocyte reduction, le white blood cell reduction, and hypertension.
data summary analysis of safety data in clinical trials of blood malignancies: This safety data summarizes and analyzes 5 ongoing Ebtoni monodrupl studies covering 266 patients.
compared to other BTK inhibitors, the safety summary results showed a lower incidence of BTK off-target-related adverse events (e.g. atrial fibrillation/atrial parathion, diarrhea, etc.).
of all 266 patients, 1 patient had an occasional level 1 atrial fibrillation and no level 3 atrial fibrillation ≥ been observed.
1 case ≥3 diarrhea (0.4%), and 1 patient with relapsed recurring incurable heterocytic lymphoma reported a second primary tumor (0.4%).
most adverse events occur during early treatment, and the frequency of adverse events decreases later in treatment.
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