Issued: 20 January 2025, London
UK
European Commission expands Jemperli (dostarlimab) plus
chemotherapy approval to all adult patients with primary advanced
or recurrent endometrial cancer
· Expanded approval includes MMRp/MSS tumours, which represent
approximately 75% of endometrial cancer cases
· Approval based on RUBY Part 1 trial, which showed a median
overall survival (OS) of 44.6 months for Jemperli plus chemotherapy vs. 28.2
months for chemotherapy alone
· Jemperli
plus chemotherapy is the only
immuno-oncology-based treatment to show statistically significant
and clinically meaningful OS benefit in the overall
population
GSK plc (LSE/NYSE: GSK) today
announced the European Commission has approved Jemperli (dostarlimab) in combination
with chemotherapy (carboplatin and paclitaxel) for first-line
treatment of adult patients with primary advanced or recurrent
endometrial cancer who are candidates for systemic therapy. This
approval broadens the previous indication for Jemperli plus chemotherapy in the
European Union (EU) to include patients with mismatch repair
proficient (MMRp)/microsatellite stable (MSS) tumours, which
represent approximately 75% of patients diagnosed with endometrial
cancer and who have limited treatment options.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "For the first time, all
patients with primary advanced or recurrent endometrial cancer in
the EU have an approved immuno-oncology-based treatment that has
shown a statistically significant and clinically meaningful overall
survival benefit. We're proud Jemperli continues to redefine the
treatment landscape for patients."
Dr Mansoor Raza Mirza, Chief
Oncologist, Copenhagen University Hospital, Denmark, and RUBY
principal investigator said: "Clinicians
have been waiting for years for an immuno-oncology-based option
that can meaningfully improve overall survival outcomes for
patients with MMRp/MSS primary advanced or
recurrent endometrial cancer. The expanded approval represents a
significant advance that delivers on this hope, now for patients
with both dMMR/MSI-H and MMRp/MSS tumours."
The European
Commission's approval to expand the use of
Jemperli plus chemotherapy
is based on results from Part 1 of the RUBY phase III trial.
RUBY Part 1 is the only clinical trial in this setting to show a
clinically meaningful and statistically significant overall
survival (OS) benefit in the full population of patients with
primary advanced or recurrent endometrial
cancer, demonstrating a 31% reduction in risk of
death (HR: 0.69; 95% CI: 0.54-0.89) compared to chemotherapy
alone.
At the 2.5-year landmark, the chance
of being alive was 61% (95% CI: 54-67) for patients in
the Jemperli plus chemotherapy group
(245 patients) compared to 49% (95% CI: 43-55) in the chemotherapy
group (249 patients). In addition, a 16.4-month improvement in
median OS was observed with Jemperli plus chemotherapy versus
chemotherapy alone (44.6 months [95% CI: 32.6-NR] vs. 28.2 months
[95% CI: 22.1-35.6], respectively). The median duration of
follow-up was more than three years.[1] The safety and tolerability analysis from
RUBY Part 1 showed a safety profile for Jemperli plus
carboplatin-paclitaxel that was generally consistent with the
known safety profiles of the individual agents. The most
common treatment-emergent adverse reactions (≥ 10%) in patients
receiving Jemperli plus chemotherapy were
rash, rash maculopapular, hypothyroidism, pyrexia, alanine
aminotransferase increased, aspartate aminotransferase increased
and dry skin.
OS data were presented at the Society of Gynecologic Oncology Annual
Meeting on Women's Cancer on 16 March 2024[2], and were published in
Annals of Oncology on 9
June 2024[3]. The label for Jemperli plus chemotherapy in the
US was expanded to all adult patients with
primary advanced or recurrent endometrial cancer in August
2024.
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,[4] with an estimated 1.6 million people
living with active disease at any stage and 417,000 new cases
reported each year worldwide.[5] Incidence rates are expected to
rise by approximately 40% between 2020 and 2040.[6] In Europe, approximately
121,000 people are estimated to be diagnosed with primary advanced
or recurrent endometrial cancer each year.[7] Approximately 15-20% of
patients with endometrial cancer will be diagnosed with advanced
disease at the time of diagnosis.[8]
Among patients with primary advanced or recurrent
endometrial cancer, approximately 75% have MMRp/MSS
tumours.[9]
About RUBY
RUBY is a two-part global, randomised, double-blind,
multicentre phase III trial of 785 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 progression-free survival (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 mismatch repair deficient (dMMR)/microsatellite
instability-high (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 opportunities for transformational
outcomes.
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. This includes patients
with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved 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. Additionally, Jemperli is 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 and paclitaxel, for the first-line
treatment of adult patients with 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 in
immuno-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.
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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 Q3 Results for 2024.
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