GSK provides update on feladilimab, an investigational inducible T cell co-stimulatory (ICOS) agonist

GlaxoSmithKline plc today announced, following a recommendation by the Independent Data Monitoring Committee, that it has taken the decision to stop enrolling patients in the phase II INDUCE-3 trial, including discontinuing treatment with feladilimab.

The INDUCE-3 study is investigating feladilimab in combination with pembrolizumab versus placebo in combination with pembrolizumab in patients with PD-L1 positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma.

GSK has also made the decision to stop the INDUCE-4 phase II trial, a study investigating feladilimab versus placebo in combination with pembrolizumab and chemotherapy.

The totality of the data will be evaluated to assess the impact on the overall clinical development programme for feladilimab.

The INDUCE-3 and INDUCE-4 studies are conducted pursuant to an agreement between GSK and Merck & Co, Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the US and Canada).

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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.