GlaxoSmithKline announced the decision to halt the phase 2 INDUCE-3 and INDUCE-4 trials, which are evaluating its investigational inducible T cell co-stimulatory (ICOS) agonist feladilimab (GSK3359609) in patients with head and neck squamous cell carcinoma. The decision to halt enrollment into the Phase II INDUCE-3 trial follows a recommendation from the Independent Data Monitoring Committee. The company also chose to halt INDUCE-4. GlaxoSmithKline did not reveal the reasons why the two trials were stopped.
The INDUCE-3 study is designed to evaluate feladilimab as part of a combination treatment alongside Merck & Co’s Keytruda (pembrolizumab), versus placebo plus Keytruda for patients with PD-L1 positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma.
INDUCE-4 is investigating feladilimab versus placebo in combination with Keytruda and chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma.
The company will evaluate the totality of data in order to determine a future path forward.
Previously reported data from the INDUCE-1 study demonstrated good efficacy in a combination arm of feladilimab plus Keytruda in head and neck squamous cell carcinoma patients who had received up to five prior lines of therapy in the advanced setting. These patients received either a combination of feladilimab plus Keytruda or feladilimab monotherapy. In the combination arm, the overall response rate was 24% – these responses were durable, with all patients maintaining benefit for at least six months or longer.
About feladilimab (GSK3359609)
Feladilimab (GSK3359609) is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody. The antibody targets and binds to ICOS expressed on tumor infiltrating CD4-positive T cells.