REG - GSK PLC - EMA validates Jemperli filing for new indication

GSKAnnouncement

25/04/2023 07:00

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RNS Number : 2822X  GSK PLC  25 April 2023

Issued: 25 April 2023, London UK

 

European Medicines Agency validates marketing authorisation application for
Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H
primary advanced or recurrent endometrial cancer

 

·   Regulatory submission based on pivotal data from Part 1 of the RUBY
phase III trial

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) validated the Company's Type II Variation for a potential new indication
for Jemperli (dostarlimab) in combination with chemotherapy for the treatment
of adult patients with a type of gynaecological cancer known as mismatch
repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary
advanced or recurrent endometrial cancer. As a result, the EMA's Committee for
Medicinal Products for Human Use will begin the formal review process to make
a recommendation to the European Commission regarding marketing authorisation
for the potential new indication.

The regulatory submission is based on the interim results of the
RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The trial met its primary
endpoint of investigator-assessed progression-free survival, showing a
statistically significant and clinically meaningful benefit versus placebo
plus chemotherapy in patients treated with dostarlimab plus
carboplatin-paclitaxel in the dMMR/MSI-H population. In addition, the safety
and tolerability profile of dostarlimab in combination with
carboplatin-paclitaxel was generally consistent with the known safety profiles
of the individual agents. The results
(https://www.gsk.com/en-gb/media/press-releases/phase-iii-ruby-clinical-trial-demonstrates-potential-of-jemperli-plus-chemotherapy-to-redefine-the-treatment-of-primary-advanced-or-recurrent-endometrial-cancer/)
were presented on 27 March 2023 at a European Society for Medical Oncology
Virtual Plenary and the Society of Gynecologic Oncology Annual Meeting and
simultaneously published in The New England Journal of Medicine.

 

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development,
GSK said: "New treatment options are urgently needed for patients with primary
advanced or recurrent endometrial cancer. With this initial filing, we are
accelerating the submission of a potential new indication for dostarlimab in
the patient population that demonstrated the strongest treatment effect in the
RUBY phase III trial. These patients currently face significant unmet medical
needs, and this combination could change the treatment paradigm for this
condition. The RUBY phase III trial continues to follow patients for the
dual-primary endpoint of overall survival in the intent-to-treat population."

 

GSK expects US regulatory filing review based on the RUBY Phase III trial
results to occur in the first half of 2023.

 

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([ 1  (#_edn1) )(]), and incidence rates are expected to rise by
almost 40% by 2040.([ 2  (#_edn2) ][ 3  (#_edn3) ]) Approximately 15-20% of
patients with endometrial cancer will be diagnosed with advanced disease at
the time of diagnosis.([ 4  (#_edn4) ])

 

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. The primary endpoints in Part 1 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 ITT populations and OS in the overall population. Pre-specified
exploratory analyses of PFS 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.
Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent
central review, overall response rate, duration of response, disease control
rate, patient-reported outcomes, and safety and tolerability.

 

About Jemperli (dostarlimab)

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds
to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1
and PD-L2.([ 5  (#_edn5) ])

 

Jemperli is not approved anywhere in the world for use in combination with
standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab
for primary advanced or recurrent endometrial cancer. In the US, Jemperli is
approved for adult patients with mismatch repair deficient (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. 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 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.
The collaboration has resulted in three monospecific antibody therapies that
have progressed into the clinic. These are: Jemperli (GSK4057190), a PD-1
antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a
LAG-3 antagonist. GSK is responsible for the ongoing research, development,
commercialisation, and manufacturing of each of these medicines under the
agreement.

 

Important Information for Jemperli in the EU

 

Indication 

Jemperli is indicated 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)  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

GSK is committed to maximising patient survival through transformational
medicines. GSK's pipeline is focused on immuno-oncology, tumour cell targeting
therapies and synthetic lethality. Our goal is to achieve a sustainable flow
of new treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies, and
antibody-drug conjugates, either alone or in combination.

 

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/company
(https://www.gsk.com/en-gb/company/) .

 

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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 the company's Annual Report on Form 20-F for 2022,
GSK's Q4 Results for 2022 and any impacts of the COVID-19 pandemic.

 

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 References

 1  (#_ednref1) Faizan U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In:
StatPearls  Internet . Treasure Island (FL): StatPearls Publishing; 2022 Jan-.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK562313/.

 2  (#_ednref2) Braun MM, et al. Am Fam Physician. 2016;93(6):468-474.

 3  (#_ednref3) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed 13 July
2022.

 4  (#_ednref4) Kantar Health, Cust Study (2018).

 5  (#_ednref5) 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.

 

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