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Phase III CADENZA study of BIVV 009 shows safety and efficacy in cold agglutinin disease.- Bioverativ Inc./Sanofi

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Published:12th Jun 2021
Results from Part A of CADENZA, a pivotal Phase III double-blind, placebo-controlled study of the use of BIVV 009 (sutimlimab), from Bioverativ Inc./Sanofi, evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), will be presented in an oral session at the European Hematology Association 2021 Congress.

Results show that seventy-three percent (n=16) of patients treated with sutimlimab met the primary composite endpoint, demonstrating improvement in hemoglobin at least 1.5 g/dL from baseline at treatment assessment timepoint (Weeks 23, 25, and 26); avoidance of transfusions from Week 5 through Week 26; and avoidance of other CAD-related therapies beyond what was permitted from Week 5 through Week 26 compared to 15% (n=3) in the placebo group (Odds Ratio=15.9, 95% CI: 2.9 to 88.0, p<0.001). data also showed sutimlimab increased and sustained mean hemoglobin levels from baseline to treatment assessment timepoint (week 26) representing a statistically significant least squares (ls) mean difference of 2.6 g dl (p><0.001; 95% ci:1.8 to 3.4) when compared with placebo. hemoglobin improved rapidly, with a ls mean increase from baseline of at least 1 g dl by week 1 and at least 2 g dl by week 3. overall mean hemoglobin levels were maintained>11 g/dL from Week 3 through treatment assessment timepoint, demonstrating a sustained effect throughout the remainder of the treatment period. A statistically significant improvement in fatigue as measured by FACIT-Fatigue assessment was achieved in patients treated with sutimlimab when compared to the placebo group, 10.8 points versus 1.9, respectively, with a LS mean difference of 8.9 points (p<0.001; 95% ci:4.0 to 13.9). a 5 or greater point increase in facit-fatigue score suggests a clinically important change. #patients treated with sutimlimab had greater mean reductions in bilirubin, a key marker of hemolysis, from baseline to treatment assessment timepoint as compared with the placebo group (-22.1 ul l versus -1.8 ul l respectively). mean bilirubin levels were normalized below the upper limit of normal within 1 to 3 weeks in the sutimlimab group (upper limit of reference range 20.5 µmol l) and maintained levels below the upper limit of normal to week 26. treatment with sutimlimab led to meaningful improvements in ldh, an additional hemolysis marker, from baseline to treatment assessment timepoint compared to placebo ( -150.8 u l versus +7.6 u l). twenty-one patients (95.5%) in the sutimlimab group and 20 patients (100%) in the placebo group experienced at least one treatment emergent adverse event (teae). three patients (13.6%) in the sutimlimab group experienced at least one treatment-emergent serious adverse event (tesae) (n="4)," including one tesae assessed by the investigator as related to sutimlimab (cerebral venous thrombosis in a patient with a history of diabetes). one patient (5%) in the placebo group had three tesaes. treatment emergent adverse events reported more often in the sutimlimab group vs. placebo (difference of at least 3 patients between groups) were: headache (23% versus 10%), hypertension (23% versus 0%), rhinitis (18% versus 0%), raynaud’s phenomenon (18% versus 0%), and acrocyanosis (14% versus 0%). no deaths or meningococcal infections were reported.the data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of c1-activated hemolysis in people with cad, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study.></0.001;></0.001;></0.001).>

Condition: Cold Agglutinin Disease
Type: drug

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