REG - GSK PLC - GSK receives US FDA file acceptance for Jemperli

GSKAnnouncement

06/06/2023 07:00

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RNS Number : 7258B  GSK PLC  06 June 2023

Issued: 6 June 2023, London UK

 

GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus
chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent
endometrial cancer

 

·   Submission accepted for Priority Review

·   Breakthrough Therapy designation granted for this potential indication

·   Application being reviewed under the FDA Project Orbis framework, which
enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore
and United Kingdom health authorities

 

 

 

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 chemotherapy for the treatment of
adult patients with mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) primary advanced or recurrent endometrial cancer. If
approved in this patient population, dostarlimab plus chemotherapy could
represent the first meaningful frontline treatment advancement in decades for
patients with primary advanced or recurrent endometrial cancer.

 

The FDA granted Priority Review for this application and assigned a
Prescription Drug User Fee Act action date of 23 September 2023. Dostarlimab
also was recently granted Breakthrough Therapy designation for this potential
new indication.

 

Under Project Orbis, an initiative from the FDA Oncology Center of Excellence
that provides a framework for concurrent submission and review of oncology
products among international partners, the dostarlimab sBLA will be reviewed
by health authorities in the US, Australia, Canada, Switzerland, Singapore and
the United Kingdom.

 

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development,
GSK said: "We are excited about this initial filing for this potential new
indication for dostarlimab in the patient population that demonstrated the
strongest treatment effect in the phase III RUBY trial. Long-term outcomes for
patients with primary advanced or recurrent endometrial cancer remain poor,
and there is an urgent need to evolve the current standard of care, which is
platinum-based chemotherapy. We look forward to working with the FDA and other
health authorities as they review this application."

 

Endometrial cancer is the most common gynaecologic cancer in developed
countries,([ 1 ]) and there are about 60,000 new cases of endometrial cancer
diagnosed every year in the US. ([ 2 ]) Approximately 15-20% of patients with
endometrial cancer will be diagnosed with advanced disease at the time of
diagnosis. ([ 3 ] [ 4 ]) An estimated 20-29% of all endometrial cancers are
dMMR/MSI-H.([( 5 ))] Chemotherapy used alone is the current standard of care
for primary advanced or recurrent endometrial cancer, and many patients
eventually experience disease progression.([ 6 ])

( )

Currently, in endometrial cancer, dostarlimab is approved in the US as
monotherapy in dMMR recurrent or advanced endometrial cancer that has
progressed on or following a prior platinum-containing regimen. If the sBLA is
approved, dostarlimab could potentially be indicated earlier in treatment in
combination with platinum-containing chemotherapy for patients with dMMR/MSI-H
primary advanced or recurrent endometrial cancer.

 

The sBLA is based on the prespecified interim analysis results from Part 1 of
the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The trial met its primary
endpoint of investigator-assessed progression-free survival (PFS), which
demonstrated a statistically significant and clinically meaningful benefit in
patients treated with dostarlimab plus carboplatin-paclitaxel in the
dMMR/MSI-H population and in the overall population. The data reflect a robust
median duration of follow-up of ≥24.8 months. 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. These data
(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
(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 at the European Society for Medical Oncology (ESMO) Virtual
Plenary and the Society of Gynecologic Oncology (SGO) Annual Meeting on 27
March 2023, and were simultaneously published in The New England Journal of
Medicine.

 

Part 1 of the RUBY trial continues to assess the dual-primary endpoint of
overall survival (OS) in the intent-to-treat (ITT) population. At the first
interim analysis in the ITT population, a clinically meaningful OS trend was
observed among patients receiving dostarlimab plus chemotherapy followed by
dostarlimab. The OS analysis was done at 33% maturity and statistical
significance was not reached.

 

In April, the European Medicines Agency (EMA) validated
(https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-validates-marketing-authorisation-application-for-jemperli-dostarlimab
(https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-validates-marketing-authorisation-application-for-jemperli-dostarlimab/)
) GSK's marketing authorisation application for dostarlimab plus chemotherapy
for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial
cancer.

 

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 dual-primary endpoints in Part 1 are investigator-assessed
progression-free survival (PFS) based on the Response Evaluation Criteria in
Solid Tumours v1.1 and overall survival (OS). The statistical analysis plan
included pre-specified analyses of PFS in the mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) and intent-to-treat (ITT)
populations and OS in the overall population. Pre-specified exploratory
analyses of PFS in the mismatch repair proficient (MMRp)/microsatellite stable
(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. ([ 7 ])

 

In the US, Jemperli is indicated 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
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.
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.

 

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

 

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.

 

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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,
and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

 

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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: https://www.ncbi.nlm.nih.gov/books/NBK562313/.

 2  American Cancer Society. Key Statistics For Endometrial Cancer.
https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html.
Updated February 14, 2022. Accessed March 29, 2023.

 3  Cerner Enviza CancerMPact® Patient Metrics 2022. CMP:CancerMPact®
[Patient Metrics], Cerner Enviza. Available from www.cancermpact.com. Accessed
11 May 2023.

 4  CancerMPact® [Treatment Architecture], Cerner Enviza. Available from
www.cancermpact.com. Accessed 11 May 2023.

 5  Cerner Enviza CancerMPact® [Treatment Architecture]. Available from
www.cancermpact.com. Accessed 14 Apr 2023.

 6  Halla K. Emerging Treatment Options for Advanced or Recurrent Endometrial
Cancer. J Adv Pract Oncol. 2022 Jan;13(1):45-59. doi:
10.6004/jadpro.2022.13.1.4. Epub 2022 Feb 1. PMID: 35173988; PMCID:
PMC8805805.

 7  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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