Bristol Myers Squibb (BMS) has reported topline data from the Phase III ACTIV-1 Immune Modulators clinical trial, where treatment with Orencia (abatacept) boosted survival in individuals admitted to the hospital with Covid-19.
A selective costimulation modulator, Orencia interrupts the continuous cycle of T-cell activation.
Sponsored by the US National Institutes of Health (NIH), the trial analysed the safety and efficacy of a single dose of immune modulators, including an intravenous 10mg/kg dose of Orencia, versus placebo, along with the standard of care.
The trial assessed whether modulating the response of the immune system could expedite recovery and lower mortality in hospitalised adults with moderate to severe Covid-19.
According to the findings, Orencia offered a robust but not statistically significant improvement compared to placebo in the primary endpoint of time to recovery, as assessed by the day of hospital discharge.
Orencia lowered the risk of death and boosted the clinical status of trial subjects versus placebo at 28 days, assessments of the secondary endpoints comprising mortality and clinical status showed.
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A 11% risk of mortality was reported in subjects who were given Orencia compared to 15% for subjects in the placebo arm, with the chances of death being 37.4% lower.
For both moderately and severely ill subjects, the relative improvement in mortality was comparable.
Subjects in the Orencia arm had 34.2% enhanced chances of clinical improvement versus those in the placebo arm.
Orencia’s safety profile was found to be consistent without any new safety signals observed in the trial.
Based on the latest data, the company intends to discuss these results and the further steps with the US Food and Drug Administration.
Bristol Myers Squibb chief medical officer Samit Hirawat said: “We are pleased with the data demonstrating the risk of death was lower for participants who received Orencia and look forward to continued collaboration with the NIH to assess the data and potentially bring this treatment option to those in need.”
In May this year, BMS reported initial analysis data results from the Phase II PILOT trial, where Breyanzi (lisocabtagene maraleucel) provided substantial durable responses in adults with refractory or relapsed large B-cell lymphoma.