GSK's ICOS Agonist Antibody GSK3359609 Granted Clinical Approval in China for Combination Therapy with Keytruda in Head and Neck Squamous Cell Carcinoma

By Baihuawen

On May 15, GlaxoSmithKline’s GSK3359609 injection was approved for clinical trials in China, in combination with pembrolizumab for the treatment of head and neck squamous cell carcinoma (HNSCC).

GSK3359609 is an inducible T-cell co-stimulator (ICOS) agonist antibody that selectively enhances T-cell function. Currently, no drugs targeting this mechanism have been approved for marketing worldwide. GSK3359609 is in the global Phase III clinical trial stage.

Source: PharmaCube NextPharma

In October 2019, GSK presented the results of the INDUCE-1 study at the ESMO Congress, demonstrating that GSK3359609 in combination with Keytruda exhibited highly promising antitumor activity in patients with head and neck squamous cell carcinoma (HNSCC) who had not previously received PD-1/L1 immune checkpoint inhibitor therapy. Among the 34 evaluable patients receiving the combination treatment, the overall response rate (ORR) was 24%; all responding patients maintained a duration of response ≥6 months; and the median progression-free survival (PFS) was 5.6 months. Among the 21 patients with PD-L1 expression, the majority of responders and patients with stable disease had a PD-L1 score <20.

Head and neck cancer is currently the sixth most common malignant tumor worldwide, with 400,000 to 600,000 new cases globally each year. The prognosis after first-line chemotherapy is extremely poor, with a five-year survival rate of less than 4% for metastatic and advanced head and neck cancers, resulting in a very high mortality rate. In October 2019, Opdivo was approved in China for the new indication of treating recurrent or metastatic squamous cell carcinoma of the head and neck.