REG - GSK PLC - FDA Expands Jemperli Approval

GSKAnnouncement

02/08/2024 07:00

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RNS Number : 8948Y  GSK PLC  02 August 2024

Issued: 1 August 2024, London UK

 

US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult
patients with primary advanced or recurrent endometrial cancer as the first
and only immuno-oncology-based treatment to show an overall survival benefit

 

 * Jemperli approval now includes MMRp/MSS tumours, which represent majority of
endometrial cancer cases

 * Jemperli plus chemotherapy demonstrated a statistically significant and
clinically meaningful 31% reduction in risk of death versus chemotherapy alone

 

 

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and
paclitaxel (chemotherapy) followed by Jemperli as a single agent for the
treatment of adult patients with primary advanced or recurrent endometrial
cancer. This approval broadens the previous indication for Jemperli plus
chemotherapy to include patients with mismatch repair proficient
(MMRp)/microsatellite stable (MSS) tumours who represent 70-75% of patients
diagnosed with endometrial cancer and who have limited treatment options. The
supplemental Biologics License Application (sBLA) supporting this expanded
indication received Priority Review and was approved ahead of the Prescription
Drug User Fee Act action date.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: ÒJemperli plus chemotherapy is the first and only immuno-oncology
regimen to show significant and meaningful improvement in overall survival for
adult patients with primary advanced or recurrent endometrial cancer
regardless of biomarker status. We are thrilled this option is now available
for more patients in the US, including the 70-75% with MMRp/MSS tumours where
treatment options have been limited.Ó

 

TodayÕs expanded approval is based on results from dual primary endpoints of
investigator-assessed progression-free survival (PFS) and overall survival
(OS) from Part 1 of the RUBY phase III trial. RUBY Part 1 is the only clinical
trial in this setting to show a statistically significant OS benefit in the
full population of patients with primary advanced or recurrent endometrial
cancer, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI:
0.54Ð0.89) compared to chemotherapy alone.

 

At the 2.5-year landmark, 61% (95% CI: 54-67) of patients in the Jemperli plus
chemotherapy group compared to 49% (95% CI: 43-55) in the chemotherapy group
were alive. In addition, a 16.4-month improvement in median OS was observed
with Jemperli plus chemotherapy versus chemotherapy alone (44.6 months [95%
CI: 32.6ÐNR] vs. 28.2 months [95% CI: 22.1Ð35.6], respectively). The median
duration of follow-up was more than three years. 1  (#_edn1) The safety and
tolerability analysis from RUBY Part 1 showed a safety profile for Jemperli
and carboplatin-paclitaxel that was generally consistent with the known safety
profiles of the individual agents. The most common treatment-emergent adverse
events (³ 20%) in patients receiving Jemperli plus chemotherapy were nausea,
alopecia, fatigue, peripheral neuropathy, anaemia, arthralgia, constipation,
diarrhoea, myalgia, rash, hypomagnesemia, decreased appetite, peripheral
sensory neuropathy and vomiting.

 

Matthew Powell, MD, Chief, Division of Gynecologic Oncology, Washington
University School of Medicine, and US principal investigator of the RUBY trial
said: ÒThe initial approval of Jemperli plus chemotherapy was
practice-changing for patients with dMMR/MSI-H primary advanced or recurrent
endometrial cancer and todayÕs expanded approval will offer even more
patients the opportunity for improved outcomes. This is the only
immuno-oncology treatment regimen that has shown a statistically significant
overall survival benefit for the full patient population, which is a
meaningful step forward in treating this challenging cancer.Ó

 

Adrienne Moore, Survivor, Founding Member and President of Endometrial Cancer
Action Network for African-Americans (ECANA) said: ÒWith this expanded
approval for Jemperli plus chemotherapy, GSK is bringing a much-needed new
treatment regimen to the endometrial cancer community that may help patients
with primary advanced or recurrent endometrial cancer live longer, providing
hope to patients and their families. Survivors and advocates should be excited
by todayÕs news and especially delighted that this approval means that more
patients in the US who are diagnosed with endometrial cancer will have a new
treatment option.Ó

 

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 in
developed countries, 2  (#_edn2) with an estimated 1.6 million people living
with active disease at any stage and 417,000 new cases reported each year
worldwide. 3  (#_edn3) Incidence rates are expected to rise by approximately
40% between 2020 and 2040. 4  (#_edn4) Approximately 15-20% of patients with
endometrial cancer will be diagnosed with advanced disease at the time of
diagnosis. 5  (#_edn5)  Among patients with primary advanced or recurrent
endometrial cancer, approximately 70-75% have MMRp/MSS tumours. 6  (#_edn6)

 

About RUBY

RUBY is a two-part global, randomised, double-blind, multicentre phase III
trial of patients with primary advanced or recurrent endometrial cancer. Part
1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo.
Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed
by placebo.

 

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on
the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical
analysis plan included pre-specified analyses of PFS in the mismatch repair
deficient (dMMR)/microsatellite instability-high (MSI-H) and overall
populations and OS in the overall population. Pre-specified exploratory
analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H
populations were also performed. RUBY Part 1 included a broad population,
including histologies often excluded from clinical trials and had
approximately 10% of patients with carcinosarcoma and 20% with serous
carcinoma.

 

In Part 2, the primary endpoint is investigator-assessed PFS in the overall
population, followed by PFS in the MMRp/MSS population, and OS in the overall
population is a key secondary endpoint. Additional secondary endpoints in Part
1 and Part 2 include PFS per blinded independent central review, PFS2, overall
response rate, duration of response, disease control rate, patient-reported
outcomes, and safety and tolerability.

 

RUBY is part of an international collaboration between the European Network of
Gynaecological Oncological Trial groups (ENGOT), a research network of the
European Society of Gynaecological Oncology (ESGO) that consists of 22 trial
groups from 31 European countries that perform cooperative clinical trials,
and the GOG Foundation, a non-profit organisation dedicated to transforming
the standard of care in gynaecologic oncology.

About Jemperli (dostarlimab)

Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the
backbone of GSKÕs ongoing immuno-oncology-based research and development
programme. A robust clinical trial programme includes studies of Jemperli
alone and in combination with other therapies in 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 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.

 

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

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 ÒRisk factorsÓ in GSKÕs Annual Report on Form 20-F for 2023, and
GSKÕs Q2 Results for 2024.

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References

 

 1  (#_ednref1) Powell MA, Bj¿rge L, Willmott L, et al. Overall survival in
patients with endometrial cancer treated with dostarlimab plus
carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial, Annals
of Oncology.2024. doi: https:// doi.org/10.1016/j.annonc.2024.05.546.

 2  (#_ednref2) Faizan U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In:
StatPearls  Internet . Treasure Island (FL): StatPearls Publishing; 2022 Jan.
Available at: www.ncbi.nlm.nih.gov/books/NBK562313/.

 3  (#_ednref3) 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;71(3):209-249. doi:10.3322/caac.21660

 4  (#_ednref4) International Research on Cancer. Global Cancer Observatory.
Cancer Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 12 Jun 2024.

 5  (#_ednref5) CMP: CancerMPact(¨) Patient Metrics Mar-2023, Cerner Enviza.
Available at www.cancermpact.com. Accessed 12 Jun 2024.

 6  (#_ednref6) Based on CMP:CancerMPact(¨) [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 12 Jun 2024.

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