REG - GSK PLC - US FDA accepts new indication filing for Jemperli

GSKAnnouncement

24/04/2024 07:00

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RNS Number : 7718L  GSK PLC  24 April 2024

Issued: 24 April 2024, London UK

 

US FDA accepts for priority review GSK's application for an expanded
indication of Jemperli (dostarlimab) plus chemotherapy to include all adult
patients with primary advanced or recurrent endometrial cancer

 

·   Application supported by statistically significant and clinically
meaningful progression-free and overall survival data from phase III RUBY Part
1 trial

·   Dostarlimab plus chemotherapy is the only immuno-oncology-based therapy
to show a statistically significant and clinically meaningful survival benefit
in the overall patient population

·    23 August 2024 assigned as Prescription Drug User Fee Act action date
for FDA decision

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) accepted the supplemental Biologics License Application (sBLA) for
Jemperli (dostarlimab) in combination with standard-of-care chemotherapy
(carboplatin and paclitaxel) to expand treatment to all adult patients with
primary advanced or recurrent endometrial cancer. This would include patients
with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.

 

Currently, Jemperli is FDA-approved 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 either
mismatch repair deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H).

 

The FDA granted Priority Review for this application and assigned a
Prescription Drug User Fee Act action date of 23 August 2024.

 

The sBLA 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 survival benefit in the overall patient population.
The safety and tolerability analysis from RUBY showed a safety profile for
dostarlimab and carboplatin-paclitaxel that was generally 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 (SGO) Annual Meeting on Women's Cancer
on 16 March 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, with approximately 417,000 new cases reported each year
worldwide(1), and incidence rates are expected to rise by almost 40% between
2020 and 2040.(2)(,)(3) Approximately 15-20% of patients with endometrial
cancer will be diagnosed with advanced disease at the time of
diagnosis.(4) Among patients with primary advanced or recurrent endometrial
cancer, approximately 70-75% have MMRp/MSS tumours.(5)

 

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 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.(6)

 

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.

 

Please see accompanying US Prescribing Information
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-MG.PDF).

 

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 the company's Annual Report on Form 20-F for 2023.

 

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References

1.     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/
(http://www.ncbi.nlm.nih.gov/books/NBK562313/) .

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

3.     International Research on Cancer. Global Cancer Observatory. Cancer
Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 23 Apr 2024.

4.     CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza.
Available at www.cancermpact.com. Accessed 23 Apr 2024.

5.     Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 23 Apr 2024.

6.     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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