REG - GSK PLC - Jemperli plus chemotherapy positive CHMP opinion

GSKAnnouncement

16/10/2023 07:00

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RNS Number : 1504Q  GSK PLC  16 October 2023

Issued: 16 October 2023, London UK

 

GSK receives positive CHMP opinion recommending approval of Jemperli
(dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H
primary advanced or recurrent endometrial cancer

·   If approved, dostarlimab would become the first new frontline treatment
option in the European Union (EU) in decades and the only immuno-oncology
combination regimen available for this patient population with high unmet need

·   Decision on EU marketing authorisation expected by the end of the year

 

 

GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending approval of Jemperli (dostarlimab) in
combination with carboplatin-paclitaxel (chemotherapy), 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. The CHMP opinion is one of the final
steps prior to a marketing authorisation decision by the European
Commission.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "We are pleased with this positive CHMP opinion and the potential for
dostarlimab with chemotherapy to treat patients with this very challenging
form of endometrial cancer. If approved, dostarlimab plus chemotherapy will be
the first new treatment option in decades for these patients in the European
Union, offering long-awaited new hope for improved long-term outcomes. This
opinion further reinforces our confidence in dostarlimab's important role in
the immuno-oncology treatment landscape."

 

GSK's application for the authorisation of dostarlimab is based on interim
analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III
trial, which were presented
(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/)
) at the European Society for Medical Oncology (ESMO) Virtual Plenary and
Society of Gynecologic Oncology (SGO) Annual Meeting on 27 March 2023, and
simultaneously published in The New England Journal of Medicine. The trial
results reflect a robust median duration of follow-up of ≥ 25 months. Part 1
of the RUBY trial met its primary endpoint of investigator-assessed
progression-free survival (PFS) in patients treated with dostarlimab plus
carboplatin and paclitaxel in the dMMR/MSI-H population. In the dMMR/MSI-H
population, a 72% reduction in the risk of disease progression or death was
observed (HR: 0.28 [95% CI: 0.16-0.50]).

 

In a prespecified, exploratory analysis of overall survival (OS) in the
dMMR/MSI-H population, the addition of dostarlimab to chemotherapy resulted in
a 70% reduction in the risk of death relative to chemotherapy alone (HR: 0.30
[95% CI: 0.13-0.70]).

 

The safety and tolerability profile for dostarlimab plus carboplatin and
paclitaxel was generally consistent with the known safety profiles of the
individual agents. The most common adverse reactions (≥ 10%) in patients
receiving dostarlimab plus chemotherapy were rash, hypothyroidism (overactive
thyroid), increased alanine aminotransferase or increased aspartate
aminotransferase (increased liver enzyme levels in the blood), pyrexia (fever)
and dry skin.

 

This opinion follows the July 2023 expansion of the label for Jemperli in the
US to include this indication
(https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/
(https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/)
). The new indication for Jemperli 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, Jemperli was also approved in the United Kingdom earlier this
month in combination with platinum-containing chemotherapy for the treatment
of adult patients with dMMR/MSI-H primary advanced or recurrent endometrial
cancer and who are candidates for systemic therapy. The application remains
under review in Australia, Canada, Switzerland and Singapore.

 

In the EU, Jemperli currently has conditional approval as a monotherapy for
treating adult patients with dMMR/MSI-H recurrent or advanced endometrial
cancer that has progressed on or following prior treatment with a
platinum-containing regimen. If the European Commission approves the frontline
indication for Jemperli + chemotherapy, this conditional approval is expected
to be converted to full approval at the same time. A decision is expected by
the end of this year.

 

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% by 2040.
( )2(,)3( ) Approximately 15-20% of patients with endometrial cancer will be
diagnosed with advanced disease at the time of diagnosis. ( 4  ) An estimated
20-29% of all endometrial cancers are dMMR/MSI-H 5 . In the EU4 (France,
Germany, Italy and Spain), approximately 3,000 people are estimated to be
diagnosed with dMMR/MSI-H primary advanced or recurrent endometrial cancer
each year 6 .

 

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 ITT 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 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.

 

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 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
(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli)

 

GSK in oncology

GSK is committed to maximising patient survival through transformational
medicines, with a current focus on breakthroughs in immuno-oncology and
tumour-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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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 Q2 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/.
(https://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. https://gco.iarc.fr/tomorrow/en/dataviz/
(https://gco.iarc.fr/tomorrow/en/dataviz/) . Accessed 13 July 2022.

 4  Kantar Health, Cust Study (2018).

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

 6  Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza. Available
from www.cancermpact.com (http://www.cancermpact.com) . Accessed 28 Sept 2023.

 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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