REG - GSK PLC - Jemperli full FDA approval following GARNET trial

GSKAnnouncement

10/02/2023 07:16

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RNS Number : 5648P  GSK PLC  10 February 2023

10 February 2023, London UK

 

US FDA grants regular approval for Jemperli for the treatment of patients with
recurrent or advanced mismatch repair-deficient endometrial cancer

 

·   Conversion from accelerated to regular (full) approval based on
long-term outcomes from the GARNET phase I trial, which demonstrated an
overall response rate of 45.4%

·   85.9% of patients had duration of response ≥12 months and 54.7% of
patients had duration of response ≥24 months

 

 

GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration
(FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment
of 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.

 

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development,
GSK, said: "This US regulatory action confirms our confidence in Jemperli as
an important treatment option for patients with dMMR recurrent or advanced
endometrial cancer. We continue to unlock the potential of Jemperli as the
backbone for our immuno-oncology development programmes to address the unmet
needs of patients, including earlier lines of endometrial cancer and other
solid tumours."

 

In April 2021, Jemperli received accelerated approval for the treatment of
adult patients with dMMR recurrent or advanced endometrial cancer that had
progressed on or following prior treatment with a platinum-containing regimen.

 

This approval is based on additional data collected from the A1 expansion
cohort of the ongoing GARNET trial, a phase I, multicentre, open-label,
single-arm study of Jemperli monotherapy in patients with advanced or
recurrent solid tumours. Cohort A1 evaluated the efficacy of Jemperli in 141
patients with dMMR advanced or recurrent endometrial cancer that has
progressed on or following prior treatment with a platinum-containing regimen.
The major efficacy outcome measures were overall response rate (ORR) and
duration of response (DOR) as assessed by a blinded independent central review
according to RECIST v1.1. Confirmed ORR was 45.4% (95% CI: 37.0, 54.0), with a
15.6% complete response rate and a 29.8% partial response rate. Median DOR was
not reached (range: 1.2+, 52.8+ months), measured from the time of first
response, with 85.9% of patients having duration ≥12 months and 54.7% of
patients having duration ≥24 months. Median follow-up for duration of
response was 27.9 months.

 

Treatment-related adverse events were consistent with previous analyses for
cohort A1. The most common adverse reactions (≥20%) were fatigue/asthenia,
anaemia, rash, nausea, diarrhoea, constipation, and vomiting. The most common
Grade 3 or 4 adverse reactions (≥2%) were anaemia, increased transaminases,
urinary tract infection, fatigue/asthenia, and diarrhoea.

 

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
globally, with approximately 417,000 new cases reported each year
worldwide([( 1  (#_edn1) ))(]), and incidence rates are expected to rise by
almost 40% by 2040.([( 2  (#_edn2) ))][( 3  (#_edn3) )] Approximately 15-20%
of patients with endometrial cancer will be diagnosed with advanced disease at
the time of diagnosis.([( 4  (#_edn4) ))]

 

About GARNET

The ongoing GARNET phase I trial is evaluating Jemperli as monotherapy in
patients with advanced solid tumours. Part 2B of the study includes five
expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair
proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2),
non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut
solid tumour basket cohort (cohort F), and platinum-resistant ovarian cancer
without BRCA mutations (cohort G). GARNET continues to enrol patients.

 

In cohort A1, patients received 500mg of Jemperli as an intravenous infusion
once every three weeks (Q3W) for four doses, followed by 1,000mg once every
six weeks until disease progression, discontinuation or withdrawal.

 

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  (#_edn5) ))] GSK's ambition is for Jemperli to become the
backbone of the Company's ongoing immuno-oncology-based research and
development programme when used alone and in combination with standard of care
and future novel cancer therapies, particularly for patients who currently
have limited treatment options. Jemperli is being investigated in
registrational enabling studies as monotherapy and as part of combination
regimens, including in patients with recurrent or primary advanced endometrial
cancer, patients with Stage III or IV non-mucinous epithelial ovarian cancer,
and patients with other advanced solid tumours or metastatic cancers.

 

In the US, Jemperli is indicated 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. 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.

 

Please see accompanying US Prescribing Information.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-MG.PDF)

 

GSK in oncology

GSK is committed to maximising patient survival through transformational
medicines. GSK's pipeline is focused on immuno-oncology, tumour cell targeting
therapies and synthetic lethality. Our goal is to achieve a sustainable flow
of new treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies, and
antibody-drug conjugates, either alone or in combination.

 

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 Q4 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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References

 

 1  (#_ednref1) Sung H, Ferlay J, Siegel R et al. Global cancer statistics
2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers
in 185 countries. CA Cancer J Clin. 2021. doi:10.3322/caac.21660.

 2  (#_ednref2) Braun MM, et al. Am Fam Physician. 2016;93(6):468-474.

 3  (#_ednref3) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed 13 July
2022.

 4  (#_ednref4) Kantar Health, Cust Study (2018).

 5  (#_ednref5) 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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