GlaxoSmithKline PLC Data show anti-tumour activity with ICOS agonist (0432O)
30 Septiembre 2019 - 1:00AM
UK Regulatory
TIDMGSK
RNS Number : 0432O
GlaxoSmithKline PLC
29 September 2019
Issued: 28 September 2019, London UK
GSK presents new data showing promising anti-tumour activity
with GSK3359609, an ICOS receptor agonist, in combination with
pembrolizumab in head and neck squamous cell carcinoma (HNSCC)
Data presented at ESMO 2019 support initiation of phase II/III
registrational trial with pembrolizumab in first-line
recurrent/metastatic HNSCC
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 maximising 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.
GSK enquiries:
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Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement 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.
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[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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