FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending
19 March
2019
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued: 19 March 2019, London UK - LSE Announcement
Data from GARNET study indicates robust activity of dostarlimab in
patients with advanced or recurrent endometrial cancer
●
GARNET is the single largest study to
date of an anti-PD-1 monotherapy in women with advanced or
recurrent MSI-H and MSS endometrial cancer
●
Results demonstrate clinically
meaningful and durable response rates of dostarlimab monotherapy,
in MSI-H and MSS tumours
●
BLA submission planned for dostarlimab
in endometrial cancer at the end of 2019
TESARO, an oncology-focused business acquired by GlaxoSmithKline
plc (LSE/NYSE: GSK), announced today the presentation of data from
the Phase 1/2 GARNET study evaluating dostarlimab in women with
recurrent or advanced endometrial cancer who progressed on or after
a platinum-based regimen. These data were presented at the 2019
Society for Gynecologic Oncology (SGO) Annual Meeting on Women's
Cancer in Honolulu, Hawaii. The preliminary results demonstrate
clinically meaningful and durable response rates of dostarlimab
(anti-PD-1 antibody, formerly TSR-042), in this patient population,
regardless of microsatellite instability status. In addition, the
safety findings indicate that dostarlimab is well tolerated with a
safety profile consistent with what is expected of anti-PD-1
therapy.
Further data from the GARNET study will be analysed using the
RECIST 1.1 criteria to support regulatory filing for dostarlimab in
endometrial cancer at the end of 2019.
Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of
TESARO, said, "Currently, treatment options for women with advanced
or recurrent endometrial cancer are limited, with only one
FDA-approved agent for a subset of these patients. We intend to use
these and other data from the GARNET study to seek regulatory
approval of dostarlimab to potentially address the critical unmet
treatment needs of women whose disease has progressed. The data
presented today evaluating dostarlimab in women with
recurrent/advanced endometrial cancer, combined with earlier data
in patients with non-small cell lung cancer, reinforces the
potential of dostarlimab in treating patients with a variety of
solid tumours."
Endometrial cancer (EC) is the most common gynaecologic malignancy
in the U.S. There are limited treatment options for women whose
disease progresses on or after first-line therapy. EC can be
classified as microsatellite stable (MSS/75%) or microsatellite
instability-high (MSI-H/25%). Currently, there is only one approved
therapy in the recurrent EC setting for the subset of patients with
MSI-H tumours, and no approved treatments for patients with MSS EC
who have recurred after platinum-based chemotherapy.
Key Study Findings
A total of 125 patients were analysed including 41 MSI-H (33%), and
79 MSS (63%) patients, as well as 5 with an unknown MSI-status
(4%). Dostarlimab was dosed at 500 mg once every 3 weeks for 4
doses, followed by 1000 mg once every 6 weeks until disease
progression.
Determination of MSI status was made based upon a central test
using next generation sequencing (NGS). Treatment with dostarlimab
monotherapy resulted in a clinically meaningful response rate in
recurrent or advanced EC who progressed on or after a
platinum-based regimen, regardless of MSI status. Overall response
rates by irRECIST in the full population, MSI-H population, and MSS
population were 30%, 49%, and 20%, respectively. Disease control
rate in the full population, MSI-H population, and MSS population
was 53%, 63% and 47%, respectively.
At the time of data cutoff, treatment was still ongoing in 84% of
responders, with 89% of the responders (33 of 37) having been on
treatment for more than six months and 49% of responders (18 of 37)
having been on treatment for more than one year. Durability of
response was similar between the MSI-H and MSS cohorts. The median
duration of response (DOR) has not yet been reached. All responses
were assessed using irRECIST criteria.
The data show that 88 out of 125 (70.4%) patients had at least 1
treatment-emergent adverse event (TEAE). The most commonly reported
TEAEs related to dostarlimab were fatigue (14.4%), diarrhea
(12.8%), and nausea (12.0%). In general, adverse events were low
grade, with only 13.6% of patients experiencing grade 3 or higher
adverse events. No deaths occurred due to a treatment-related
adverse event. In total, 5.6% of all patients experienced a grade 3
or higher immune related, treatment-related adverse
event.
About GARNET
The ongoing Phase 1/2 GARNET trial is evaluating dostarlimab as
monotherapy in patients with advanced solid tumours. GARNET
included a weight-based dose escalation study (Part 1) and a
fixed-dose safety study (Part 2A), both of which have been
completed. Results of these studies were used to determine the
recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles
then 1000 mg Q6W). Part 2B of the study includes four expansion
cohorts: MSI-H endometrial cancer, MSI-H non-endometrial cancer,
MSS endometrial cancer, and non-small cell lung cancer (NSCLC).
Data from the NSCLC cohort have been previously presented at
Society for Immunotherapy of Cancer (SITC) in 2018.
About dostarlimab
Dostarlimab (TSR-042) is an investigational humanized
anti-programmed death (PD)-1 monoclonal antibody that binds with
high affinity to the PD-1 receptor and effectively blocks its
interaction with the ligands PD-L1 and PD-L2. If approved,
dostarlimab would be the first anti PD-1 therapy administered as
monotherapy every 3 weeks for 4 doses then every 6 weeks
thereafter. Dostarlimab was developed as part of a collaboration
between TESARO and AnaptysBio, Inc. This collaboration was
initiated in March of 2014, and is focused on the development of
monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and
LAG-3 (TSR-033), in addition to a bi-specific antibody drug
candidate targeting PD-1/LAG-3 (TSR-075).
Dostarlimab is not currently approved for use anywhere in the
world.
About TESARO
TESARO, an oncology-focused business within GSK, devoted to
providing transformative therapies to people facing cancer. For
more information, visit
www.tesarobio.com
,
and follow us on
Twitter
and
LinkedIn
.
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
.
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GSK and TESARO 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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Kristin Ainsworth
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+1 781 786 7007
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(Massachusetts)
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Mary Anne Rhyne
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+1 919 483 0492
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(North Carolina)
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Analyst/Investor enquiries:
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Sarah Elton-Farr
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+44 (0) 208 047 5194
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(London)
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Danielle Smith
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+44 (0) 20 8047 7562
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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 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.
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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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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: March
19, 2019
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By: 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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