Phase III ACTIV-1 trial of Orencia shows recovery time improvement in COVID-19.- BMS
Bristol Myers Squibb announced topline results from the Phase III Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, which evaluated the safety and efficacy of a single dose of immune modulators, including Orencia (abatacept) IV (10 mg/kg) versus placebo when given with standard of care to determine if modulating the immune system’s response could speed recovery and reduce death in adults hospitalized with moderate to severe COVID-19.
Treatment with Orencia versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by day of hospital discharge.
Analyses of the secondary endpoints, which included mortality and clinical status, demonstrated Orencia reduced participants’ risk of death and improved their clinical status at 28 days after entering the study when compared with placebo. The risk of death was lower for participants who received Orencia at 11%, versus 15% for those who received placebo, and the odds of dying were 37.4% lower. The relative improvement in mortality was similar in both moderately and severely ill participants. People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group.
The safety profile of Orencia remained consistent, with no new safety signals reported in the study. The full report on these data will be published in a peer-reviewed scientific journal. Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the FDA.
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