GlaxoSmithKline (GSK) has reported Phase II results for its investigational monoclonal antibody otilimab in hospitalised COVID-19 patients – and the data is mixed.
The primary endpoint in the Phase II OSCAR study was the number of COVID-19 patients who remained alive and free of respiratory failure 28 days after receiving a single dose of otilimab plus standard of care, compared to standard of care alone.
Pooled data from patients of all ages showed a treatment difference of 5.3% for otilimab versus standard of care, although this did not reach statistical significance.
Despite the disappointing results in the all-comer population, 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 otilimab treatment, compared to 45.9% in the standard of care group.
On top of that, a mortality analysis up to day 60 demonstrated a treatment difference of 14% favouring otilimab. This reflects a mortality rate of 40% on standard of care versus 26% on otilimab plus standard of care in patients aged 70 years and older.
Following the promising results in the older sub-group, GSK has amended the OSCAR study to expand this cohort and confirm the findings.
The additional cohort will follow a similar study design and is set to enrol around 350 patients aged 70 years and older.
“Patients aged 70 and over account for 70% of COVID-related deaths and nearly 40% of hospitalisations. Our scientific understanding of COVID-19 continues to evolve at a rapid pace with recent studies suggesting that GM-CSF is elevated in this group of patients,” said Christopher Corsico, senior vice president development, GSK.
“Given the profound impact this pandemic is having on the elderly and the encouraging data we are sharing today, we are hopeful this finding will be replicated in the additional cohort,” he added.