# GSK’s Jemperli granted FDA approval for patients with dMMR recurrent or advanced endometrial cancer

- Link: https://www.directorstalkinterviews.com/gsks-jemperli-granted-fda-approval-for-patients-with-dmmr-recurrent-or-advanced-endometrial-cancer/4121105118
- Published: 2023-02-10T07:41:13+00:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
LSE/NYSE:GSK) has reported 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, and incidence rates are expected
to rise by almost 40% by 2040. Approximately 15-20% of patients with endometrial
cancer will be diagnosed with advanced disease at the time of diagnosis.

**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. 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.

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.

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