On September 30, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK ) reported an inducible T cell costimulatory molecule (ICOS) designed to selectively enhance T cell function The agonist antibody GSK3359609 exhibits promising antitumor activity in combination with pemizumab in the treatment of patients with head and neck squamous cell carcinoma (HNSCC) PD-1/L1 (Press release, GlaxoSmithKline, SEP 30, 2019, View Source;834146127.html [SID1234539959]). The results of the INDUCE-1 study also showed that GSK3359609 has a single drug activity in the treatment of patients with head and neck squamous cell carcinoma PD-1/L1.
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The safety and tolerability of GSK3359609 is consistent with the results reported in the INDUCE-1 (dose escalation phase). The data was released at the 2019 European Conference of Cancer Society in Barcelona, Spain.
GlaxoSmithKline reported that the inducible T cell costimulatory molecule (ICOS) agonist antibody GSK3359609, which is designed to selectively enhance T cell function, is combined with pemizumab for the treatment of head and neck squamous cell carcinoma (HNSCC) PD- The 1/L1 initial treatment patient showed promising anti-tumor activity.
Dr. Axel Hoos , senior vice president and head of oncology research and development , said: "GSK3359609 and other immunotherapy are key components in the field of oncology. INDUCE-1 data demonstrates that GSK3359609 enhances antitumor activity (beyond We are encouraged by the potential of PD-1 to block the anti-tumor activity. The observed clinical response is very encouraging. Based on the precedent of CTLA-4 or PD-1, we want to prove our ICOS The main effect of agonists is to improve patient survival, and this requires further research. Based on these results, we will launch the INDUCE-3 registration trial, which combines the use of GSK3359609 and pemizumab to treat first-line recurrence/metascale head and neck scales. Potential survival benefits of patients with squamous cell carcinoma (PD-L1 positive)."
The published data comes from the development phase of INDUCE-1, the first open-label study in humans to study GSK3359609 as a monotherapy and a combination of other regimens. The patients in the study had relapsed or metastatic head and neck squamous cell carcinoma, and had previously received up to five therapies in the late stages. Patients in the monotherapy group were previously treated with PD-1/L1 and 1 mg/kg GSK3359609. Patients in the combination drug group received PD-1/L1 treatment for the first time, taking 0.3 mg/kg GSK3359609 and 200 mg pemizumab. Patients in both groups received a two-year assessment until the condition progressed or unacceptable toxicity occurred.
Of the 34 patients who received combination therapy, the overall response rate was 24% (n=8; 95% CI: 11,58.7). Remission in the combination drug group was long-lasting, and all responders maintained a 6-month or longer improvement (no median; 95% CI: 4.2 months, NR); median progression-free survival (PFS) ) for 5.6 months (95% CI: 2.4, 7.4). Among the 21 patients with known PD-L1 expression data, most responders and stable patients had a PD-L1 score of less than 20 points. Among the 16 patients who underwent monotherapy, the overall response rate was 6% (n = 1; 95% CI: 0.2, 30.2).
The INDUCE-1 study was conducted in accordance with an agreement between GlaxoSmithKline and Merck & Co, Inc. ("MSD" outside the United States and Canada). GlaxoSmithKline will continue to work with MSD to support the INDUCE-3 Phase II/III combination drug trials to be launched by the end of 2019.
Head and neck squamous cell carcinoma is a cancer developed from squamous cells in the mouth, nose and throat mucosa. It is the seventh most common cancer in the world, with approximately 600,000 newly diagnosed cases each year. i Although head and neck squamous cell carcinoma is more common in the over 50-year-old or 60-year-old men, but the incidence in younger individuals is increasing. Ii Head and neck squamous cell carcinoma tumors are highly immunogenic and have high expression of immunological checkpoint regulators (including ICOS and PD-1). Iii
The GSK3359609 Clinical Development Program
GSK3359609 clinical development program aims to investigate the anti-tumor potential of a variety of tumor-targeted ICOS receptors by single agonist antibodies in combination with other immunological checkpoint therapies.
GSK3359609 is not currently approved for use anywhere in the world.
i Genetics Home Reference. Head and neck squamous cell carcinoma – Genetics Home Reference – NIH. US National Library of Medicine. View Source Statistics. Published January 2015 . Accessed September 1, 2019 .
I National Institute of Health. Head and neck squamous cell carcinoma. US National Library of Medicine. View Source. Published August 20, 2019 .
Iii Canning M, et al. Heterogeneity of the Head and Neck Squamous Cell Carcinoma Immune Landscape and Its Impact on Immunotherapy. Front Cell Dev Biol. 2019; 7: 52.
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GlaxoSmithKline’s performance in the field of oncology
GlaxoSmithKline is committed to maximizing patient survival by converting drugs. GlaxoSmithKline focuses on immuno-oncology, cell therapy, cancer epigenetics and overall mortality. The company’s goal is to achieve a sustainable flow of new therapies based on a diverse portfolio of research drugs, using small molecules, antibodies, antibody drug combinations and cells, either alone or in combination.