- The conversion of this indication from Notice of Compliance
(NOC/c) to full approval (NOC) is based on long term outcomes from
the GARNET phase I trial, which demonstrated an objective response
rate of 45.5% in patients with recurrent or advanced mismatch
repair deficient (dMMR)/microsatellite instability-high (MSI-H)
endometrial cancer that has progressed on or following prior
treatment with a platinum containing regimen
- This approval supports GSK's continued commitment to addressing
the unmet needs of patients with gynaecological cancer
MISSISSAUGA, ON, July 24,
2024 /CNW/ - GSK today announced that Health Canada
granted full approval for Jemperli (dostarlimab for
injection) as a monotherapy for the treatment of adult patients
with dMMR/MSI-H recurrent or advanced endometrial cancer that has
progressed on or following prior treatment with a platinum
containing regimen.
"We remain committed to exploring the full potential of
Jemperli as the foundation of our immuno-oncology portfolio,
aiming to meet the needs of patients in various stages of
endometrial cancer and other types of solid tumours," said
Marni Freeman, Country Medical
Director at GSK Canada. "This approval in Canada reaffirms our belief in the value of
Jemperli as a treatment choice for patients who are living
with dMMR/MSI-H recurrent or advanced endometrial cancer."
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.
Confirmed objective response rate (ORR) was 45.5% (95% CI: 37.1,
54.0), and the median duration of response (DOR) was not reached
(range: (1.18+, 47.21+months), with a median follow-up for duration
of response of 27.6 months.
In December 2021, Jemperli
was granted NOC/c by Health Canada as a monotherapy for this
indication in adult patients with dMMR or MSI-H recurrent or
advanced endometrial cancer that has progressed on or following
prior treatment with a platinum-containing regimen. Additionally,
in November 2023, Jemperli in
combination with carboplatin and paclitaxel was approved in
Canada as a treatment option in
combination with carboplatin and paclitaxel for adult patients with
primary advanced or recurrent dMMR/MSI-H endometrial cancer in
patients who are candidates for systemic therapy. Jemperli
in combination with carboplatin and paclitaxel recently received
positive funding recommendations from Canada's health technology assessment bodies
and the file is now under active negotiation with the pan-Canadian
Pharmaceutical Alliance (pCPA). GSK is committed to working with
the pCPA and the drug programs to support widespread and timely
access for primary advanced and recurrent endometrial cancer
patients.
About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus,
known as the endometrium. Endometrial cancer is one of the most
common gynaecologic cancers in developed
countriesi with about 8,100 new cases of
endometrial cancer diagnosed every year in Canada.ii Incidence rates are
expected to rise by almost 40% by 2040.iii
iv
Approximately 15-20% of patients with endometrial cancer will be
diagnosed with advanced disease at the time of
diagnosis. v vi An estimated 20-29% of all
endometrial cancers are dMMR/MSI-H.vii Chemotherapy has
been the current standard of care for the majority of patients with
primary advanced or recurrent endometrial cancer, and many patients
eventually experience disease progression. viii
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).
About Jemperli (dostarlimab for
injection)
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.
ix
In Canada, Jemperli (dostarlimab
for injection) is indicated in combination with carboplatin and
paclitaxel for the treatment of adult patients with primary
advanced or recurrent mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) endometrial cancer
who are candidates for systemic therapy, and as monotherapy for the
treatment of adult patients with dMMR or MSI-H recurrent or
advanced endometrial cancer that has progressed on or following
prior treatment with a platinum containing regimen. Jemperli
has also been accepted for review by Health Canada for an expanded
indication in primary advanced endometrial cancer.
Please consult the Product
Monograph at www.gsk.ca for complete safety
information. The Product Monograph is also available by calling
1-800-387-7374.
GSK in gynaecologic oncology
GSK is committed to maximizing patient survival through
transformational medicines with a current effort on breakthroughs
in oncology, including gynaecologic cancers, some of the most
common cancers affecting women. We are focused on developing new
medicines across a range of different modalities both as
monotherapy and in combination for a variety of cancers, including
ovarian and endometrial. We have a unique research and development
approach, utilizing synthetic lethality and immuno-oncology to
target specific proteins and biomarkers in ovarian cancer and
endometrial cancer, enabling us to develop targeted treatments.
About GSK
We are a global biopharma company with a purpose to unite
science, technology and talent to get ahead of disease together.
Find out more at gsk.ca.
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10.6004/jadpro.2022.13.1.4. Epub 2022 Feb 1. PMID: 35173988; PMCID:
PMC8805805.
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ix Laken H,
Kehry M, Mcneeley P, et al. Identification and characterization of
TSR-042, a novel anti-human PD-1 therapeutic antibody. European
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doi:10.1016/s0959-8049(16)32902-1.
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SOURCE GlaxoSmithKline Inc.