REG - GSK PLC - EMA validates Jemperli marketing authorisation

GSKAnnouncement

24/06/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240624:nRSX4604Ta&default-theme=true

RNS Number : 4604T  GSK PLC  24 June 2024

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  (#_edn1) , and were published in Annals
of Oncology on 9 June 2024 2  (#_edn2) .

 

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  (#_edn3) , and incidence rates are expected to rise by almost 40%
between 2020 and 2040. 4  (#_edn4) (,) 5  (#_edn5) In Europe, approximately
121,000 people are estimated to be diagnosed with primary advanced or
recurrent endometrial cancer each year. 6  (#_edn6) Approximately 15-20% of
patients with endometrial cancer will be diagnosed with advanced disease at
the time of diagnosis. 7  (#_edn7)  Among patients with primary advanced or
recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumours. 8 
(#_edn8)

 

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 enquiries
 Media:               Tim Foley                                 +44 (0) 20 8047 5502  (London)
                      Simon Moore / Dan Smith / Sarah Clements  +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn                            +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer                             +1 202 302 4595       (Washington DC)

 Investor Relations:  Nick Stone                                +44 (0) 7717 618834   (London)
                      James Dodwell                             +44 (0) 20 8047 2406  (London)
                      Mick Readey                               +44 (0) 7990 339653   (London)
                      Josh Williams                             +44 (0) 7385 415719   (London)
                      Camilla Campbell                          +44 (0) 7803 050238   (London)
                      Steph Mountifield                         +44 (0) 7796 707505   (London)
                      Jeff McLaughlin                           +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco                          +1 215 751 4855       (Philadelphia)

 

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.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

 1  (#_ednref1)
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/

 2  (#_ednref2) 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.

 3  (#_ednref3) 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/.

 4  (#_ednref4) Braun MM, et al. Am Fam Physician. 2016;93(6):468-474.

 5  (#_ednref5) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. gco.iarc.fr/tomorrow/en/dataviz/. Accessed 13 July 2022.

 6  (#_ednref6) 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.

 7  (#_ednref7) CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza.
Available at www.cancermpact.com. Accessed 29 Feb 2024.

 8  (#_ednref8) Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 01 Mar 2024.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCSELFIFELSEFM