Sutimlimab meets primary endpoint in treating cold agglutinin disease

pharmafile | June 11, 2021 | News story | Medical Communications  

A Phase III study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) met its primary endpoint.

Results from the trial demonstrated the treatment resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD.

These findings reinforce that sutimlimab results in rapid inhibition of C1-activated hemolysis within one week of treatment, and had a sustained treatment effect throughout the study.

Professor Alexander Röth, Principal Investigator, said: “Cold agglutinin disease causes the body’s immune system to mistakenly destroy its healthy red blood cells.

“People living with cold agglutinin disease experience the crippling impact of chronic hemolysis that can cause severe anemia, profound fatigue, and can have acute hemolytic crisis.

“The positive evidence from the CADENZA trial demonstrate significant improvements in hemolysis and meaningful impact on key measures of anemia and fatigue.”

The primary efficacy outcome was the proportion of patients who met all three of the following components: improvement in hemoglobin ≥1.5 g/dL from baseline at treatment assessment timepoint, (average of weeks 23, 25, and 26); avoidance of transfusions from week five through week 26; and avoidance of other CAD-related therapies beyond what was permitted from week five through week 26.

The secondary efficacy measures assessed improvement from baseline in key indicators of the disease process including hemoglobin, bilirubin, lactate dehydrogenase (LDH) levels, and quality of life as measured by functional assessment of chronic illness therapy (FACIT)-fatigue score.

Karin Knobe, M.D., Head of Development, Rare and Rare Blood Disorders, Sanofi, said: “The results from CADENZA and data from the Phase 3 CARDINAL study, presented as a late-breaker at the American Society of Hematology congress in 2019, will be the basis of our filing with the European Medicines Agency.

“Together, the studies highlight the promising potential of sutimlimab to have a meaningful impact for people living with CAD. Based on the robust clinical evidence we have to-date, sutimlimab significantly inhibits hemolysis and has the potential to be an important new treatment for CAD.”

CAD is a rare, chronic autoimmune hemolytic anemia that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their destruction (hemolysis) via activation of the classical complement pathway.

CAD patients may experience chronic anemia, profound fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thromboembolic events and early death.

CAD impacts the lives of an estimated 12,000 people in the US, Europe, and Japan. There are currently no approved therapies for CAD.

Lilly Subbotin

Related Content

No items found

Latest content