UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of September, 2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Kristen
Neese
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+1
(804) 217-8147
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Danielle
Smith
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+44 (0)
20 8047 2406
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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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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Registered in England & Wales:
No.
3888792
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Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: September
30, 2019
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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