REG - GSK PLC - FDA approves new use for Jemperli plus chemo

GSKAnnouncement

31/07/2023 18:15

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RNS Number : 8069H  GSK PLC  31 July 2023

Issued: 31 July 2023, London UK

 

Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new
frontline treatment option in decades for dMMR/MSI-H primary advanced or
recurrent endometrial cancer

 

·      Jemperli is the only immuno-oncology treatment approved in the
frontline setting for this patient population in combination with chemotherapy

·      Patients with this type of endometrial cancer face significant
unmet need and typically experience poor long-term outcomes with the current
standard of care

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Jemperli (dostarlimab) 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 mismatch repair deficient (dMMR), as determined by an
FDA-approved test, or microsatellite instability-high (MSI-H). The
supplemental Biologics License Application (sBLA) supporting this new
indication received Priority Review and was approved ahead of the Prescription
Drug User Fee Act action date.

 

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development,
GSK, said: "Today's expanded approval of Jemperli redefines the treatment
landscape for patients with dMMR/MSI-H primary advanced or recurrent
endometrial cancer. Until now, chemotherapy alone has been the standard of
care with many patients experiencing disease progression. In the RUBY trial,
Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease
progression or death versus chemotherapy in this patient population, providing
a statistically significant and clinically meaningful benefit. These results
and today's approval underscore our belief in the potential for Jemperli to
transform cancer treatment as a backbone immuno-oncology therapy."

 

With this approval, Jemperli is now indicated earlier in treatment in
combination with chemotherapy for patients with dMMR/MSI-H primary advanced or
recurrent endometrial cancer. Jemperli is already approved in the US as
monotherapy in adult patients with dMMR recurrent or advanced endometrial
cancer that has progressed on or following a prior platinum-containing regimen
in any setting and are not candidates for curative surgery or radiation.

 

Matthew Powell, MD, Chief, Division of Gynecologic Oncology, Washington
University School of Medicine, and US principal investigator of the RUBY trial
said: "As a clinician, I celebrate the practice-changing potential of adding
Jemperli to chemotherapy for patients with dMMR/MSI-H primary advanced or
recurrent endometrial cancer who have had limited treatment options. Based on
the results from the RUBY clinical trial, I look forward to the addition of
Jemperli to chemotherapy becoming a new standard of care for patients."

 

Wenora Johnson, President, Board of Directors, Facing Our Risk of Cancer
Empowered (FORCE) said: "The endometrial cancer community is thrilled by
today's news, which changes the treatment paradigm for a population with
long-term unmet needs. FORCE is grateful for the many participants and
researchers who contributed to this important study. As an endometrial cancer
survivor, I know how much this approval offers hope for patients with primary
advanced or recurrent dMMR/MSI-H endometrial cancer."

 

The FDA approval is supported by interim analysis results from Part 1 of the
RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which reflect a robust median
duration of follow-up of ≥ 25 months. The trial met the primary endpoint of
investigator-assessed progression-free survival (PFS), demonstrating a
statistically significant and clinically meaningful benefit in patients
treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H
population. In the dMMR/MSI-H population, a 71% reduction in the risk of
disease progression or death was observed. Part 1 of the RUBY trial continues
to assess overall survival (OS) in the intent-to-treat (ITT) population, a
dual-primary endpoint alongside investigator-assessed PFS.

 

The safety and tolerability profile for Jemperli plus carboplatin and
paclitaxel was generally consistent with the known safety profiles of the
individual agents. The most common treatment-emergent adverse events (≥ 20%)
in patients receiving Jemperli plus chemotherapy were rash, diarrhoea,
hypothyroidism and hypertension.

 

The RUBY trial 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/)
were presented at the European Society for Medical Oncology (ESMO) Virtual
Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on 27 March
2023, and were simultaneously published in The New England Journal of
Medicine.

 

The sBLA supporting this new indication was reviewed under the FDA Oncology
Center of Excellence Project Orbis Framework, which allowed for concurrent
submission to and review by US and other international regulatory authorities.
As part of Project Orbis, the application remains under review in Australia,
Canada, Switzerland, Singapore and the United Kingdom. A marketing
authorisation application is also under review by the European Medicines
Agency.

 

About endometrial cancer

Endometrial cancer is one of the most common gynaecologic cancers in developed
countries,([ 1  (#_edn1) ]) and there are about 60,000 new cases of
endometrial cancer diagnosed every year in the US. ([ 2  (#_edn2) ])
Approximately 15-20% of patients with endometrial cancer will be diagnosed
with advanced disease at the time of diagnosis. ([ 3  (#_edn3) ] [ 4  (#_edn4)
]) An estimated 20-29% of all endometrial cancers are dMMR/MSI-H.([( 5 
(#_edn5) ))] Chemotherapy used alone has been the current standard of care for
primary advanced or recurrent endometrial cancer, and many patients eventually
experience disease progression.([ 6  (#_edn6) ])

 

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 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 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  (#_edn7) ])

 

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
mismatch repair deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H), and as a single agent 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. The sBLA supporting
the new indication in combination with carboplatin and paclitaxel received
Breakthrough Therapy designation from the 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.
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.

 

GSK in oncology

GSK is committed to maximising patient survival through transformational
medicines, with a current focus on breakthroughs in immuno-oncology and
tumor-cell targeting therapies, and development in haematologic malignancies,
gynaecologic cancers and other solid tumours.

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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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,
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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) 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  (#_ednref3) Cerner Enviza CancerMPact® Patient Metrics 2022.
CMP:CancerMPact® [Patient Metrics], Cerner Enviza. Available from
www.cancermpact.com. Accessed 11 May 2023.

 4  (#_ednref4) CancerMPact® [Treatment Architecture], Cerner Enviza.
Available from www.cancermpact.com. Accessed 11 May 2023.

 5  (#_ednref5) Cerner Enviza CancerMPact® [Treatment Architecture].
Available from www.cancermpact.com. Accessed 14 Apr 2023.

 6  (#_ednref6) 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  (#_ednref7) 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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