- Data accepted as a late-breaking abstract and presented as a
webinar as part of the Society of Gynecologic Oncology 2020 virtual
congress
- Patients in the updated analysis of GARNET include women with
recurrent or advanced endometrial cancer who have progressed on or
after platinum-based chemotherapy
GlaxoSmithKline plc (LSE/NYSE:GSK) today announced data from an
updated analysis of the GARNET trial, which demonstrated that
dostarlimab, an investigational anti-programmed death-1 (PD-1)
monoclonal antibody, provided clinically meaningful results in
women with recurrent or advanced mismatch repair-deficient (dMMR)
endometrial cancer who progressed on or after a platinum-based
regimen.
This updated analysis included patients with dMMR endometrial
cancer who had measurable disease at baseline and ≥6 months of
follow-up by the data cutoff (n=71). Patients received 500 mg of
dostarlimab once every three weeks for four doses, followed by
1,000 mg once every six weeks until disease progression. The
primary endpoints were confirmed objective response rate (ORR) and
duration of response (DOR), as assessed against RECIST v 1.1 by
blinded independent central review. GARNET is the largest dataset
evaluating an anti-PD-1 in endometrial cancer.
Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55)
and a disease control rate of 58% (95% CI; 45-69). Overall, 13% of
patients had a complete response and 30% of patients had a partial
response. At the time of data cutoff, with a median follow up of
11.2 months, the median DOR had not been reached (1.87+ to 19.61+
months).
Dr. Axel Hoos, Senior Vice President and Head Oncology R&D,
GSK said: “We are committed to developing medicines for patients
who face high unmet medical need. We believe in the clinical
potential of dostarlimab for women with advanced or recurrent dMMR
endometrial cancer who urgently need additional treatment options
for this incurable disease.”
Dr. Ana Oaknin, Head of the Gynaecologic Cancer Program at Vall
d’Hebron Institute of Oncology, Barcelona, and primary investigator
for GARNET said: “There are limited treatment options for women
with advanced or recurrent endometrial cancer, and prognosis of
these patients is poor. The results observed in the GARNET trial
indicate the potential of dostarlimab to offer a new treatment
option for women with this challenging disease.”
The safety population included all patients with dMMR
endometrial cancer who received at least one dose of dostarlimab
(n=104). Results showed that dostarlimab was well tolerated with a
low discontinuation rate (2%) due to treatment-related adverse
events (TRAEs), consistent with the safety profiles of other
anti-PD-1 therapies. The most commonly reported TRAEs were asthenia
(15%), diarrhea (15%), fatigue (14%), and nausea (13%). No deaths
associated with dostarlimab were reported in the study.
Dostarlimab is not currently approved for use anywhere in the
world.
About GARNET The ongoing phase I GARNET trial is
evaluating dostarlimab as monotherapy in patients with advanced
solid tumors. Part 2B of the study includes five expansion cohorts:
dMMR/microsatellite instability-high (MSI-H) endometrial cancer
(cohort A1), mismatch repair-proficient endometrial cancer (cohort
A2), non-small cell lung cancer (cohort E), dMMR/MSI-H
non-endometrial cancer (cohort F), and platinum-resistant ovarian
cancer without BRCA mutations (cohort G). GARNET is still enrolling
patients.i,ii
About Dostarlimab Dostarlimab is an investigational
humanized anti-PD-1 monoclonal antibody that binds with high
affinity to the PD-1 receptor and blocks its interaction with the
ligands PD-L1 and PD-L2.iii
In addition to GARNET, dostarlimab is being investigated for
women with recurrent or primary advanced endometrial cancer in
combination with standard of care (chemotherapy) in the phase III
RUBY trial.iv Dostarlimab is also being evaluated in combination
with other therapeutic agents for patients with advanced solid
tumors or metastatic cancer.
About Endometrial Cancerv Endometrial cancer is a main
type of uterine cancer that forms in the inner lining of the
uterus, known as the endometrium. Endometrial cancer can be
classified as mismatch repair-deficient/microsatellite
instability-high or mismatch repair-proficient/microsatellite
stable. There are limited treatment options for women whose disease
progresses on or after first-line therapy. Endometrial cancer is
the sixth most common cancer in women worldwide.vi
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 utilizing 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 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 2019.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford,
Middlesex TW8 9GS
__________________________________________ i A Phase 1 Dose
Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1
Monoclonal Antibody, in Patients with Advanced Solid Tumors
(GARNET). ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT02715284. Accessed February
2020. ii Oaknin A, Duska LR, Sullivan RJ, et al. Preliminary
safety, efficacy, and pharmacokinetic/pharmacodynamic
characterization from GARNET, a phase I/II clinical trial of the
anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent
or advanced MSI-H and MSS endometrial cancer. Presented at 2019 SGO
Annual Meeting; March 16-19, 2019; Honolulu, HI. Abstract 33. iii
Laken H, Kehry M, Mcneeley P, et al. Identification and
characterization of TSR-042, a novel anti-human PD-1 therapeutic
antibody. European Journal of Cancer. 2016;69,S102.
doi:10.1016/s0959-8049(16)32902-1. iv A Study of Dostarlimab
(TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus
Carboplatin-paclitaxel in Patients with Recurrent or Primary
Advanced Endometrial Cancer (RUBY). ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT03981796. Accessed February
2020. v Endometrial Cancer Treatment (PDQ®)– Health Professional
Version. National Cancer Institute.
https://www.cancer.gov/types/uterine/hp/endometrial-treatment-pdq.
Accessed February 2020. vi Endometrial cancer. World Cancer
Research Fund.
https://www.wcrf.org/dietandcancer/endometrial-cancer. Published
September 12, 2018. Accessed February 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200423005979/en/
GSK inquiries:
UK Media inquiries:
Simon Steel +44 (0) 20 8047 5502 (London)
Tim Foley +44 (0) 20 8047 5502 (London)
US Media inquiries:
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington DC)
Analyst/Investor inquiries:
Sarah Elton-Farr +44 (0) 208 047 5194 (London)
Danielle Smith +44 (0) 20 8047 0932 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
GSK (NYSE:GSK)
Historical Stock Chart
From Sep 2024 to Oct 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Oct 2023 to Oct 2024