REG - GSK PLC - Headline results from phase III FIRST trial

GSKAnnouncement

20/12/2024 07:00

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RNS Number : 8444Q  GSK PLC  20 December 2024

Issued: 20 December 2024, London UK

 

GSK announces FIRST trial met its primary endpoint of progression free
survival in first line advanced ovarian cancer

 

·   Addition of Jemperli (dostarlimab) to both platinum-based chemotherapy
and Zejula (niraparib) maintenance, with or without bevacizumab, demonstrated
a statistically significant effect on progression free survival (PFS) versus
active comparator arm

 

 

GSK plc (LSE/NYSE: GSK) today announced headline results from the
FIRST-ENGOT-OV44 phase III trial evaluating Zejula (niraparib) and Jemperli
(dostarlimab) in first line advanced ovarian cancer. The trial met its primary
endpoint of PFS demonstrating a statistically significant difference with the
addition of dostarlimab to both standard of care carboplatin-paclitaxel
chemotherapy and niraparib maintenance, with or without bevacizumab.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "As part of our focus in gynaecological cancers, we continue to evaluate
the potential of this combination and look forward to sharing full results
from the trial."

The key secondary endpoint of overall survival did not meet statistical
significance. Further analyses are ongoing and data will be shared with health
authorities and presented at an upcoming scientific meeting.

 

The safety and tolerability profile was generally consistent with the known
safety profiles of the individual agents.

 

About ovarian cancer

Ovarian cancer is the eighth most common cancer in women worldwide.
 1  (#_edn1)
 Despite high response rates to platinum-based chemotherapy in the first-line setting, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.
 2  (#_edn2)

 

About the FIRST trial

The FIRST-ENGOT-OV44 trial is an international, double-blind, randomised
phase III ENGOT trial sponsored by GSK and led by GINECO, a French cooperative
group dedicated to gynecological oncology. FIRST is investigating the addition
of dostarlimab to both, standard of care (SOC) platinum-based chemotherapy and
niraparib maintenance, with or without bevacizumab, as a first-line treatment
of stage III or IV nonmucinous epithelial ovarian cancer. Originally,
participants were randomised 1:1:2 into three groups: Arm 1: SOC chemotherapy
followed by placebo maintenance; Arm 2: SOC chemotherapy followed by niraparib
maintenance; Arm 3: SOC chemotherapy and dostarlimab followed by niraparib and
dostarlimab maintenance. Bevacizumab could be added at the investigator's
discretion across all arms. Due to the approvals of PARP inhibitors in the
first-line setting, Arm 1 (n=193) was closed and participants were
subsequently randomized 1:2 to Arms 2 (n= 385) and 3 (n= 753) only. The
primary endpoint is investigator-assessed PFS in Arms 2 and 3. Secondary
endpoints include OS, PFS2, time to first and second subsequent therapy.

ABOUT GINECO (http://www.arcagy.org)  3  (#_edn3)

GINECO (Groupe d'Investigateurs National pour l'Etude des Cancers de l'Ovaire
et du sein) is the French Cooperative Group in Oncology labelled by INCa
(Institut National du Cancer or French NCI) developing and conducting
gynecological and metastatic breast cancer clinical trials at the national and
international level. The GINECO group was founded in 1993 and is member of
international consortia such as ENGOT and GCIG (Gynecologic Cancer
InterGroup).

 

About ENGOT (https://engot.esgo.org/)  4  (#_edn4)

The European Network for Gynaecological Oncological Trial (ENGOT) groups is a
research network of the European Society of Gynaecological Oncology and was
founded in Berlin in October 2007. Currently, ENGOT consists of 21 trial
groups from 31 European countries that perform cooperative clinical trials.
ENGOT's ultimate goal is to bring the best treatment to gynaecological cancer
patients through the best science and enabling every patient in every European
country to access a clinical trial.

 

About Jemperli (dostarlimab)

Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the
backbone of GSK's ongoing immuno-oncology-based research and development
prgramme. A robust clinical trial programme includes studies of Jemperli alone
and in combination with other therapies for gynaecologic, colorectal and lung
cancers, as well as where there are opportunities for transformational
outcomes.

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. This includes
patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) and
dMMR/MSI-H tumours. Jemperli is also approved 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. Additionally, Jemperli is 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

Indications

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 (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.

Important Information for Zejula in the EU

Indications 

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
(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

Oncology is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic malignancies,
gynaecologic cancers, and other solid tumours through breakthroughs in
immuno-oncology and tumour-cell targeting therapies.

 

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.

 

 GSK enquiries
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 Investor Relations:  Annabel Brownrigg-Gleeson  +44 (0) 7901 101944   (London)
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                      Jeff McLaughlin            +1 215 751 7002       (Philadelphia)

 

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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

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WC1A 1DG

 

 

(#_ednref1) 1.     Worldwide Cancer Data. World Cancer Research Fund.
https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics
(https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics) /. Updated
March 23, 2022. Accessed November 2024.

(#_ednref2) 2.     Lorusso D, Mancini M, Di Rocco R, Fontanelli R,
Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer
[published online August 5, 2012]. Int J Surg Oncol. 2012.
doi:10.1155/2012/613980. Accessed November 2024.

(#_ednref3) 3.     Association for Research on Cancers including GINECO.
Available at: https://www.arcagy.org/ (https://www.arcagy.org/) Accessed 20
November 2024.

(#_ednref4) 4.         European Network of Gynaecological Oncological
Trial groups. Available at: https://engot.esgo.org/ (https://engot.esgo.org/)
Accessed 20 November 2024.

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