Issued: 24 June 2024, London
UK
Jemperli
(dostarlimab)
plus chemotherapy application accepted for review by the European
Medicines Agency to expand use to all patients with primary
advanced or recurrent endometrial cancer
· Regulatory submission supported by statistically significant
and clinically meaningful progression-free and overall survival
data from Part 1 of the phase III RUBY trial
· Dostarlimab plus chemotherapy is the only
immuno-oncology-based therapy to show a statistically significant
and clinically meaningful overall survival benefit in the broader
patient population
GSK plc (LSE/NYSE: GSK) today
announced the European Medicines Agency (EMA) has accepted its
application to expand the use of Jemperli (dostarlimab) in combination
with standard-of-care chemotherapy (carboplatin and paclitaxel) to
all adult patients with primary advanced or recurrent endometrial
cancer. The EMA's Committee for Medicinal
Products for Human Use will begin the formal review process to make
a recommendation to the European Commission, with approval expected
in H1 2025.
Currently, in the EU, Jemperli in combination with
carboplatin and paclitaxel is approved for the treatment of adult
patients who are candidates for systemic therapy with primary
advanced or recurrent endometrial cancer that is mismatch repair
deficient (dMMR) or microsatellite instability-high (MSI-H). If
this new application is approved, dostarlimab would be
expanded to all patients with primary
advanced or recurrent endometrial cancer, regardless of their
biomarker type, including those with
mismatch repair proficient (MMRp)/microsatellite stable (MSS)
tumours where currently there are no
approved frontline immuno-therapy-based treatments in the
EU.
The application is based on results
from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of
investigator-assessed progression-free survival (PFS) and overall
survival (OS), demonstrating a statistically significant and
clinically meaningful benefit in the overall population of patients
treated with dostarlimab plus carboplatin-paclitaxel versus
chemotherapy alone. RUBY Part 1 is the only clinical trial to show
a statistically significant overall survival benefit in this
patient population. The safety and tolerability analyses from RUBY
showed a safety profile for dostarlimab plus carboplatin-paclitaxel
that was generally consistent with the known safety profiles of the
individual agents.
OS data were presented at the Society
of Gynecologic Oncology Annual Meeting on Women's Cancer on 16
March 2024[1], and were published in
Annals of
Oncology on 9 June 2024[2].
About endometrial
cancer
Endometrial cancer is found in the
inner lining of the uterus, known as the endometrium. Endometrial
cancer is the most common gynaecologic cancer in developed
countries, with approximately 417,000 new cases reported each year
worldwide[3], and
incidence rates are expected to rise by almost 40% between 2020 and
2040.[4],[5] In Europe, approximately 121,000
people are estimated to be diagnosed with primary advanced or
recurrent endometrial cancer each year.[6]
Approximately 15-20% of patients with endometrial
cancer will be diagnosed with advanced disease at the time of
diagnosis.[7] Among patients with primary advanced or recurrent
endometrial cancer, approximately 70-75% have MMRp/MSS
tumours.[8]
About RUBY
RUBY is a two-part global,
randomised, double-blind, multicentre phase III trial of patients
with primary advanced or recurrent endometrial cancer. Part 1 is
evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab versus carboplatin-paclitaxel plus placebo followed by
placebo. Part 2 is evaluating dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab plus niraparib
versus placebo plus carboplatin-paclitaxel followed by
placebo.
In Part 1, the dual-primary endpoints
are investigator-assessed PFS based on the Response Evaluation
Criteria in Solid Tumours v1.1 and OS. The statistical analysis
plan included pre-specified analyses of PFS in the dMMR/MSI-H and
overall populations and OS in the overall population. Pre-specified
exploratory analyses of PFS and OS in the MMRp/MSS population and
OS in the dMMR/MSI-H populations were also performed. RUBY Part 1
included a broad population, including histologies often excluded
from clinical trials and had approximately 10% of patients with
carcinosarcoma and 20% with serous carcinoma.
In Part 2, the primary endpoint is
investigator-assessed PFS in the overall population, followed by
PFS in the MMRp/MSS population, and OS in the overall population is
a key secondary endpoint. Additional secondary endpoints in Part 1
and Part 2 include PFS per blinded independent central review,
PFS2, overall response rate, duration of response, disease control
rate, patient-reported outcomes, and safety and
tolerability.
RUBY is part of an international
collaboration between the European Network of Gynaecological
Oncological Trial groups (ENGOT), a research network of the
European Society of Gynaecological Oncology (ESGO) that consists of
22 trial groups from 31 European countries that perform cooperative
clinical trials, and the GOG Foundation, a non-profit organisation
dedicated to transforming the standard of care in gynaecologic
oncology.
About Jemperli (dostarlimab)
Jemperli, a programmed
death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK's
ongoing immuno-oncology-based research and development programme. A
robust clinical trial programme includes studies of Jemperli alone and in combination with
other therapies in gynaecologic, colorectal and lung cancers, as
well as where there are other opportunities for transformational
outcomes. It was the first immuno-oncology treatment approved, in
combination with chemotherapy, in the frontline setting for primary
advanced or recurrent dMMR/MSI-H endometrial cancer.
In the US, Jemperli is indicated in combination
with carboplatin and paclitaxel, followed by Jemperli as a single agent for the
treatment of adult patients with primary advanced or recurrent
endometrial cancer that is dMMR, as determined by a US FDA-approved
test, or MSI-H, and as a single agent for adult patients with dMMR
recurrent or advanced endometrial cancer, as determined by a US
FDA-approved test, that has progressed on or following a prior
platinum-containing regimen in any setting and are not candidates
for curative surgery or radiation. The sBLA supporting this
indication in combination with carboplatin and paclitaxel for
dMMR/MSI-H primary advanced or recurrent endometrial cancer
received Breakthrough Therapy designation and Priority Review from
the US FDA. Jemperli is
also indicated in the US for patients with dMMR recurrent or
advanced solid tumours, as determined by a US FDA-approved test,
that have progressed on or following prior treatment and who have
no satisfactory alternative treatment options. The latter
indication is approved in the US under accelerated approval based
on tumour response rate and durability of response. Continued
approval for this indication in solid tumours may be contingent
upon verification and description of clinical benefit in a
confirmatory trial(s).
Jemperli was
discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under
a collaboration and exclusive license agreement signed in March
2014. Under this agreement, GSK is responsible for the ongoing
research, development, commercialisation, and manufacturing of
Jemperli,
and cobolimab (GSK4069889), a TIM-3
antagonist.
Important Information for Jemperli
in the EU
Indication
Jemperli is
indicated:
- in
combination with carboplatin-paclitaxel, for the treatment of adult
patients with mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) primary advanced or recurrent endometrial
cancer and who are candidates for systemic therapy;
- as
monotherapy for treating adult patients with mismatch repair
deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent
or advanced endometrial cancer that has progressed on or following
prior treatment with a platinum-containing regimen.
Refer to the Jemperli
EMA Reference
Information for a full list of adverse events and
the complete important safety information in the EU here:
https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.
GSK
in oncology
Oncology is an emerging therapeutic
area for GSK where we are committed to maximising patient survival
with a current focus on haematologic malignancies, gynaecologic
cancers and other solid tumours through breakthroughs
immune-oncology and tumour-cell targeting therapies.
About GSK
GSK is a global biopharma company
with a purpose to unite science, technology, and talent to get
ahead of disease together. Find out more at gsk.com.
GSK
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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 "Risk factors" in GSK's
Annual Report on Form 20-F for 2023, and GSK's Q1 Results for
2024.
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