REG - GSK PLC - Jemperli positive trial in endometrial cancer

GSKAnnouncement

02/12/2022 07:00

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RNS Number : 3578I  GSK PLC  02 December 2022

Issued: 2 December 2022, London UK

 

Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a
planned interim analysis in patients with primary advanced or recurrent
endometrial cancer

 

·   Results showed a statistically significant and clinically meaningful
improvement in investigator-assessed progression-free survival

·   RUBY is the only first-line trial to show improvement in
progression-free survival for an immuno-oncology therapy in combination with
standard-of-care chemotherapy in primary advanced or recurrent endometrial
cancer

·   Regulatory submissions based on the trial results are planned for the
first half of 2023

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from the
planned interim analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase
III trial investigating Jemperli (dostarlimab) plus standard-of-care
chemotherapy (carboplatin-paclitaxel) followed by Jemperli compared to
chemotherapy plus placebo followed by placebo in adult patients with primary
advanced or recurrent endometrial cancer. The trial met its primary endpoint
of investigator-assessed progression-free survival (PFS). It showed a
statistically significant and clinically meaningful benefit in the
prespecified mismatch repair deficient (dMMR)/microsatellite instability-high
(MSI-H) patient subgroup and in the overall population. A clinically relevant
benefit in PFS was also observed in the mismatch repair proficient
(MMRp)/microsatellite stable (MSS) patient subgroup.

 

While the overall survival (OS) data were immature at the time of this
analysis, a favourable trend was observed in the overall population, including
both the dMMR/MSI-H and MMRp/MSS subgroups.

 

The safety and tolerability profile of dostarlimab in the RUBY phase III trial
was consistent with clinical trials of similar regimens. The most common
treatment-emergent adverse events in patients receiving dostarlimab plus
chemotherapy were nausea, alopecia, fatigue, peripheral neuropathy, anaemia,
arthralgia, constipation and diarrhoea.

 

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development,
GSK, said: "Patients with primary advanced or recurrent endometrial cancer
have limited treatment options. Long-term outcomes remain poor, and new
treatment options are urgently needed to evolve the current standard of care,
which is platinum-based chemotherapy. Based on these positive headline results
from the RUBY phase III trial, GSK intends to seek regulatory approvals for a
potential new indication for dostarlimab in the treatment of primary advanced
or recurrent endometrial cancer."

 

Regulatory submissions based on the trial results are anticipated in the first
half of 2023. Full results from the trial will be published in a medical
journal and presented at an upcoming scientific meeting.

 

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 endometrial cancer

Endometrial cancer is found in the inner lining of the uterus, known as the
endometrium. It is the most common gynaecologic cancer in the US and the
second most common gynaecologic cancer globally.(( i )) Approximately 15-20%
of women with endometrial cancer will be diagnosed with advanced disease at
the time of diagnosis.(( ii ))

 

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 primary endpoints in Part 1 are investigator-assessed PFS
based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. 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.(( iii )) Dostarlimab is being investigated in registrational
enabling studies, as monotherapy and as part of combination regimens,
including in women with recurrent or primary advanced endometrial cancer,
women with Stage III or IV non-mucinous epithelial ovarian cancer, and
patients with other advanced solid tumours or metastatic cancers.

 

In the US, dostarlimab is indicated for adult patients with dMMR recurrent or
advanced endometrial cancer, as determined by an FDA-approved test, that have
progressed on or following prior treatment with a platinum-containing regimen.
Dostarlimab is also indicated in the US for patients with dMMR recurrent or
advanced solid tumours, as determined by an FDA-approved test, that have
progressed on or following prior treatment and who have no satisfactory
alternative treatment options. These indications are approved in the US under
accelerated approval based on tumour response rate and durability of response.
Continued approval for these indications may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).

 

Dostarlimab was discovered by AnaptysBio 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: dostarlimab (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
Dostarlimab is indicated as monotherapy for the treatment of 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
(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli)
(https://www.ema.europa.eu/en/medicines/human/EPAR/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 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/company
(https://www.gsk.com/en-gb/company/) .

 

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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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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

 ii  Kantar Health, Cust Study (2018).

 iii  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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