ContRAst phase III programme for GSK 3196165 meets primary endpoint in rheumatoid arthritis.- GSK

The ContRAst phase IIl programme enrolled a broad range of difficult-to-treat patients who had an inadequate response to or could not tolerate available treatments. ContRAst-1 and ContRAst-2 met their primary endpoints of a statistically significant ACR20[1] response versus placebo at week 12 in patients with inadequate response to methotrexate (ContRAst-1) and conventional synthetic or biologic disease modifying antirheumatic drugs (DMARDs) (ContRAst-2).

Data from ContRAst-3, the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors. While the ContRAst-1 and ContRAst-2 trials met their primary endpoints, the efficacy demonstrated is unlikely to transform patient care for this difficult-to-treat patient population. Assessment of efficacy and safety data from the ContRAst programme is ongoing, however the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. As a result, GSK has decided not to progress with regulatory submissions. Full results from the ContRAst phase III programme will be submitted for publication in 2023.