LONDON, Sept. 28, 2019 /PRNewswire/
-- GlaxoSmithKline plc (LSE/NYSE: GSK) today
announced GSK3359609, an inducible T cell
co-stimulatory (ICOS) agonist antibody designed to selectively
enhance T cell function, showed promising anti-tumour
activity in combination with pembrolizumab in PD-1/L1 naive
patients with head and neck squamous cell carcinoma (HNSCC).
Findings from the INDUCE-1 study also suggested GSK3359609 has
single agent activity in patients with PD-1/L1 experienced
HNSCC.
The safety and tolerability profile of GSK3359609 was
consistent with the results reported in the dose escalation phase
of INDUCE-1. The data were presented at the European Society
for Medical Oncology (ESMO) Congress 2019
in Barcelona,
Spain.
Dr. Axel Hoos, Senior Vice
President and Head Oncology R&D, said: "Immunotherapies such
as GSK3359609 are a critical part of our oncology
pipeline and we are encouraged by the INDUCE-1 data demonstrating
the potential of this agent to enhance anti-tumour activity beyond
what PD-1 blockade alone has demonstrated. The clinical responses
observed are encouraging and, based on precedent with CTLA-4 or
PD-1, we aim to demonstrate the main effect of our ICOS agonist to
be on improving survival for patients, which requires further
study. Based on these results, we are initiating the INDUCE-3
registrational trial to investigate the potential survival benefit
of GSK3359609 with pembrolizumab in first-line recurrent/metastatic
HNSCC for patients who are PD-L1 positive."
The data presented stem from the expansion phase of INDUCE-1, a
first-in-human, open-label study investigating GSK3359609 as a
monotherapy and in combination with other regimens. Patients in the
study had recurrent or metastatic HNSCC and had received up to five
prior lines of therapy in the advanced setting. Patients in the
monotherapy cohort had previously been treated with PD-1/L1 therapy
and received 1 mg/kg GSK3359609. Patients in the combination cohort
were naive to PD-1/L1 therapy and received 0.3 mg/kg GSK3359609 and
200 mg pembrolizumab. Patients in both cohorts were evaluated until
disease progression or unacceptable toxicity, for up to two years.
In the 34 evaluable patients who received the combination
therapy, the overall response rate was 24% (n=8; 95% CI: 11, 58.7).
Responses in the combination cohort were durable with all
responding patients maintaining benefit for 6 months or longer
(median not reached; 95% CI: 4.2 months, NR); the median
progression-free survival (PFS) was 5.6 months (95% CI: 2.4, 7.4).
Of the 21 patients with known PD-L1 expression data, the majority
of responders and patients with stable disease had PD-L1 score
below 20. Of the 16 evaluable patients who received monotherapy,
the overall response rate was 6% (n=1; 95% CI: 0.2, 30.2).
The INDUCE-1 study was conducted pursuant to an agreement
between GSK and Merck & Co, Inc., Kenilworth, N.J., U.S.A. (known as MSD outside
the U.S. and Canada). GSK is
continuing its relationship with MSD to support the INDUCE-3 phase
II/III combination trial to be initiated by the end of 2019.
HNSCC is a cancer that develops from squamous cells in the
mucous membranes of the mouth, nose and throat, and is the seventh
most common cancer worldwide with approximately 600,000 new cases
diagnosed each year.i Although HNSCC occurs more
frequently in men in their 50s or 60s, the incidence is increasing
among younger individuals.ii HNSCC tumours are highly
immunogenic and have an elevated expression of immune checkpoint
modulators, including ICOS and PD-1.iii
GSK3359609 Clinical Development
Programme
The clinical development
programme for GSK3359609 looks to investigate the anti-tumour
potential of targeting the ICOS receptor through an agonist
antibody alone and in combination with other immune checkpoint
therapies for the treatment of a range of tumour types.
GSK3359609 is not currently approved for use anywhere in the
world.
GSK in Oncology
GSK is focused on maximizing
patient survival through transformational medicines. GSK's pipeline
is focused on immuno-oncology, cell therapy, cancer epigenetics and
synthetic lethality. Our goal is to achieve a sustainable flow of
new treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies,
antibody drug conjugates and cells, either alone or in
combination.
About GSK
GSK is a science-led global
healthcare company with a special purpose: to help people do more,
feel better, live longer. For further information, please
visit www.gsk.com/about-us.
Cautionary statements regarding forward-looking
statements
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 under Item 3.D Principal risks and uncertainties in
the company's Annual Report on Form 20-F for 2018.
i Genetics Home Reference. Head and neck
squamous cell carcinoma - Genetics Home Reference - NIH. U.S.
National Library of Medicine.
https://ghr.nlm.nih.gov/condition/head-and-neck-squamous-cell-carcinoma#statistics.
Published January 2015. Accessed
September 1, 2019.
ii National Institute of Health. Head and neck
squamous cell carcinoma. U.S. National Library of Medicine.
https://ghr.nlm.nih.gov/condition/head-and-neck-squamous-cell-carcinoma#.
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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SOURCE GlaxoSmithKline plc