GlaxoSmithKline otilimab Phase II COVID-19 trial misses primary endpoint

CompilationFan Dongdong

A few days ago, the Phase 2 clinical trial of GlaxoSmithKline otilimab in hospitalized patients with new coronary pneumonia (COVID-19) failed to meet the primary endpoint.

The primary endpoint of the Phase II OSCAR clinical trial is to compare the proportion of COVID-19 patients with standard treatment (including antiviral therapy and glucocorticoids) and otilimab combined with standard treatment for 28 days, who are still alive and without respiratory failure.

However, the results of a pre-planned analysis of patients over 70 years of age are encouraging.

In view of the potential important clinical benefits of otilimab in the elderly subgroup of high-risk patients and public health needs, GlaxoSmithKline has decided to modify the OSCAR study and expand the recruitment trial for this cohort to be able to confirm these potentially important findings.

In the OSCAR trial, the most common serious adverse event observed was respiratory failure (5% in the control group and 4% in the otilimab group).

The drug was not originally developed by GlaxoSmithKline.

GlaxoSmithKline is interested in the efficacy of otilimab in patients 70 and older, partly because there is evidence that GM-CSF may play a greater role in the immune response of the elderly.

Although this subgroup has received positive research results, due to the relatively small sample size of the subgroup, it is difficult not to question whether the analysis of this subgroup can accurately reflect the impact of otilimab on the elderly.

In addition to COVID-19, GlaxoSmithKline is also actively studying the drug's breakthrough in the treatment of rheumatoid arthritis.

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