Older COVID-19 Patients Benefit from Monoclonal Antibody Treatment

London-based GlaxoSmithKline plc (GSK) announced results from the phase 2 proof of concept OSCAR study with otilimab (GSK3196165), an investigational anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody.

The primary endpoint of the OSCAR study was the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment with a single dose of otilimab in addition to standard of care (including anti-viral treatments and corticosteroids), compared to patients being treated with standard of care alone.

A pre-planned efficacy analysis by age in patients 70 years and older showed that 65.1% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone.

In a mortality analysis up to day 60, a treatment difference of 14.4% favoring otilimab was seen with rates of 40.4% on the standard of care vs. 26% on otilimab plus standard of care in patients 70 years and older.

Given these data suggest a potentially important clinical benefit in a pre-defined subgroup of high-risk patients and the public health need, GSK has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.

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