REG - GSK PLC - Jemperli receives positive CHMP opinion

GSKAnnouncement

16/12/2024 07:00

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RNS Number : 1207Q  GSK PLC  16 December 2024

Issued: 16 December 2024, London UK

 

Jemperli (dostarlimab) plus chemotherapy receives positive CHMP opinion to
expand approval to all adult patients with primary advanced or recurrent
endometrial cancer

·   Positive opinion based on statistically significant and clinically
meaningful progression-free and overall survival data from phase III RUBY
trial

·   An expanded approval would include MMRp/MSS tumours, which represent
majority of endometrial cancer cases

·   Approval decision expected in Q1 2025

GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended
expanding the approval of Jemperli (dostarlimab) in combination with
chemotherapy (carboplatin and paclitaxel) for first-line treatment of all
adult patients with primary advanced or recurrent endometrial cancer who are
candidates for systemic therapy. This would include patients with mismatch
repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent
70-75% of patients diagnosed with endometrial cancer and who have limited
treatment options.

The CHMP opinion is one of the final steps prior to a marketing authorisation
decision by the European Commission, with an approval decision expected in the
first quarter of 2025.  

 

The application to expand the use of dostarlimab is based on results from Part
1 of the RUBY phase III trial. The trial met its dual primary endpoints of
investigator-assessed progression-free survival (PFS) and overall survival
(OS), demonstrating a statistically significant and clinically meaningful
benefit in the full population of patients treated with dostarlimab plus
carboplatin-paclitaxel versus chemotherapy alone. Dostarlimab plus
chemotherapy is the only immuno-oncology-based regimen to show a statistically
significant OS benefit in this patient population. The safety and tolerability
analyses from RUBY showed a safety profile for dostarlimab plus
carboplatin-paclitaxel that was consistent with the known safety profiles of
the individual agents.

 

OS data were presented
(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/)
at the Society of Gynecologic Oncology Annual Meeting on Women's Cancer on 16
March 2024, and were published in Annals of Oncology
(https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/abstract) on 9
June 2024. The label for Jemperli 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, 1  (#_edn1)  with an estimated 1.6 million people
living with active disease at any stage and 417,000 new cases reported each
year worldwide. 2  (#_edn2) ( )Incidence rates are expected to rise by
approximately 40% between 2020 and 2040. 3  (#_edn3)  In Europe,
approximately 121,000 people are estimated to be diagnosed with primary
advanced or recurrent endometrial cancer each year. 4  (#_edn4)
 Approximately 15-20% of patients with endometrial cancer will be diagnosed
with advanced disease at the time of diagnosis. 5  (#_edn5) Among patients
with primary advanced or recurrent endometrial cancer, approximately 70-75%
have MMRp/MSS tumours. 6  (#_edn6)

 

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 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 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 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
(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli)
(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli) EMA Reference
Information (https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli) for a
full list of adverse events and the complete important safety information in
the EU.

 

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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 1  (#_ednref1) 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/.

 2  (#_ednref2) 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.

 3  (#_ednref3) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 04 October 2024.

 4  (#_ednref4) 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.

 5  (#_ednref5) CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza.
Available at www.cancermpact.com. Accessed 04 October 2024.

 6  (#_ednref6) Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 04 October 2024.

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