REG - GSK PLC - Jemperli plus Zejula Trial Meets Endpoint

GSKAnnouncement

18/12/2023 07:00

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RNS Number : 0708X  GSK PLC  18 December 2023

Issued: 18 December 2023, London UK

 

 

Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly
improved progression-free survival in primary advanced or recurrent
endometrial cancer in RUBY Part 2 Phase III trial

 

·   Dostarlimab plus chemotherapy followed by dostarlimab plus niraparib
improved progression-free survival vs. chemotherapy alone in both the overall
and mismatch repair proficient/microsatellite stable (MMRp/MSS) patient
populations

·   MMRp/MSS primary advanced or recurrent endometrial cancer has limited
treatment options beyond chemotherapy alone

·   Results reinforce development approach of using Jemperli as a backbone
in immuno-oncology-based combination therapies

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from a
planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial
investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy
(carboplatin and paclitaxel), followed by dostarlimab plus Zejula (niraparib)
as maintenance therapy, in adult patients with primary advanced or recurrent
endometrial cancer. The trial, which evaluated this combination against
placebo plus chemotherapy followed by placebo, met its primary endpoint of
progression-free survival (PFS), with a statistically significant and
clinically meaningful benefit observed in both the overall patient population
and in a subpopulation of patients with mismatch repair
proficient/microsatellite stable (MMRp/MSS) tumours.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "Patients with MMRp/MSS primary advanced or recurrent endometrial cancer
have few approved treatment options. Today's positive topline results
reinforce our approach of building combination therapies with dostarlimab as
the backbone in an effort to improve patient outcomes and options."

 

Analysis of the full trial data, including the key secondary endpoint of
overall survival (OS), is ongoing. OS data is immature and will continue to be
followed.

 

The safety profile of dostarlimab plus carboplatin and paclitaxel, followed by
dostarlimab plus niraparib, was generally consistent with the known safety
profiles of the individual agents.

 

Full results from this analysis will be presented at an upcoming scientific
meeting, published in a medical journal, and shared with regulatory
authorities.

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  )

 

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 mismatch repair
deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations
and OS in the overall population. Pre-specified analyses of PFS and OS in the
MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed;
however, they were not part of the hypothesis testing strategy. 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, 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. ( 5 )

 

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 supplemental Biologics License Application
supporting the new indication in combination with carboplatin and paclitaxel
received Breakthrough Therapy designation 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

(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli) for a full list
of adverse events and the complete important safety information in the EU.

 

About Zejula (niraparib)

Zejula is an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor
indicated in the US for the maintenance treatment of adult patients with
advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who
are in complete or partial response to first-line platinum-based chemotherapy;
and for the maintenance treatment of adult patients with deleterious or
suspected deleterious germline BRCA-mutated recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete or partial
response to platinum-based chemotherapy and who have been selected based on a
US FDA-approved companion diagnostic for Zejula.

 

Zejula is currently being evaluated in multiple pivotal trials. GSK continues
to build a robust clinical development programme by assessing activity across
multiple tumour types and evaluating several potential combinations of Zejula
with other therapeutics. Aiming to address the unmet medical needs of
patients, the ongoing development programme includes several combination
studies, including the FIRST phase III trial assessing niraparib in
combination with dostarlimab as a potential treatment for first-line ovarian
cancer maintenance and the phase III ZEAL trial assessing niraparib in
combination with standard of care for the maintenance treatment of first-line
advanced non-small cell lung cancer.

 

Important Information for Zejula in the EU

 

Indication

Zejula is indicated:

·      as monotherapy for the maintenance treatment of adult patients
with advanced epithelial (FIGO Stages III and IV) high-grade ovarian,
fallopian tube or primary peritoneal cancer who are in response (complete or
partial) following completion of first-line platinum-based chemotherapy.

·      as monotherapy for the maintenance treatment of adult patients
with platinum-sensitive relapsed high-grade serous epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in response (complete or
partial) to platinum-based chemotherapy.

 

Refer to the Zejula EMA Reference Information
 (https://www.ema.europa.eu/en/medicines/human/EPAR/zejula) for a full list
of adverse events and the complete important safety information in the EU.

 

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 Q3 Results 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: 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/. Accessed 13 July 2022.

 4  Kantar Health, Cust Study (2018).

 5  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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