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] 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]
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[3]
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[4]
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) 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.
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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 GSK's
Annual Report on Form 20-F for 2023, and GSK's Q3 Results for
2024.
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