REG - GSK PLC - Jemperli expanded approval in the EU

GSKAnnouncement

20/01/2025 07:00

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RNS Number : 9247T  GSK PLC  20 January 2025

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  (#_edn1)  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  (#_edn2) , and were published in Annals
of Oncology on 9 June 2024 3  (#_edn3) . 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  (#_edn4)
 with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.
 5  (#_edn5)
( )Incidence rates are expected to rise by approximately 40% between 2020 and 2040.
 6  (#_edn6)
 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year.
 7  (#_edn7)
 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.
 8  (#_edn8)
 Among patients with primary advanced or recurrent endometrial cancer, approximately 75% have MMRp/MSS tumours.
 9  (#_edn9)

 

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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WC1A 1DG

 1  (#_ednref1) Powell MA, Bjørge L, Willmott L, et al. Overall survival in
patients with endometrial cancer treated with dostarlimab plus
carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial, Annals
of Oncology.2024. doi: https:// doi.org/10.1016/j.annonc.2024.05.546.

 2  (#_ednref2)
https://www.gsk.com/en-gb/media/press-releases/positive-ruby-phase-iii-data-show-potential-for-jemperli-dostarlimab-combinations-in-more-patients-with-primary-advanced-or-recurrent-endometrial-cancer/

 3  (#_ednref3) Powell MA, Bjørge L, Willmott L, et al. Overall survival in
patients with endometrial cancer treated with dostarlimab plus
carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial, Annals
of Oncology.2024. doi: https:// doi.org/10.1016/j.annonc.2024.05.546.

 4  (#_ednref4) Faizan U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In:
StatPearls  Internet . Treasure Island (FL): StatPearls Publishing; 2022 Jan.
Available at: www.ncbi.nlm.nih.gov/books/NBK562313/.

 5  (#_ednref5) Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics
2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers
in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249.
doi:10.3322/caac.21660.

 6  (#_ednref6) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 04 October 2024.

 7  (#_ednref7) Concin N, Matias-Guiu X, Vergote I, et
al ESGO/ESTRO/ESP guidelines for the management of patients with endometrial
carcinoma International Journal of Gynecologic Cancer 2021;31:12-39.

 8  (#_ednref8) CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza.
Available at www.cancermpact.com. Accessed 18 December 2024.

 9  (#_ednref9) Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 18 December 2024.

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