New immune therapy treatment option for Australian women diagnosed with advanced endometrial cancer

  • Extended TGA approval of Jemperli (dostarlimab) now gives Australian women who are diagnosed with primary advanced or recurrent endometrial cancer the opportunity to receive this immune therapy treatment option in combination with standard chemotherapy.1-4
  • Endometrial cancer is Australia’s most common reproductive cancer, with more than 3000 women diagnosed each year.5
  • The incidence of endometrial cancer is rising, but survival rates are declining, with only 1 in 5 women diagnosed with advanced disease surviving more than five years.6

 

GSK Australia is pleased to announce the Therapeutic Goods Administration (TGA) approval of immune therapy Jemperli (dostarlimab), in combination with chemotherapy (carboplatin and paclitaxel), for the treatment of adult patients with primary advanced or recurrent endometrial cancer.1,7

This TGA approval now makes Jemperli a treatment option for women who are diagnosed with advanced endometrial cancers.1-4

Jemperli was first TGA approved last year for around 20-30% of women with advanced endometrial cancer who were found to have the mismatch repair deficient (dMMR) biomarker.4

This latest approval means women who have the mismatch repair proficient (MMRp) biomarker may now be eligible for treatment with this anti-PD 1 immune therapy option in combination with standard chemotherapy.1

“We welcome the availability of additional treatment options for all eligible women diagnosed with this challenging gynaecological cancer,” said Prof Linda Mileshkin, Director of Medical Oncology, Peter MacCallum Cancer Centre. “Sadly, we see the incidence of this cancer is rising, and at the same time,  endometrial cancer is one of few cancers where survival rates are decreasing.

“While we don’t fully understand what’s driving this it seems lifestyle factors, including rising rates of obesity in the community, play a role.6 Providing eligible Australian women with access to innovative medicines is critical to improving patient outcomes,” she adds.

And Christine Cockburn, CEO of Rare Cancers Australia, commented: “This new TGA indication for Jemperli is an important step toward greater access for patients, however, a PBS listing is the ideal outcome. For too long, progress and treatment developments in gynaecological cancers have lagged behind other, more common cancers, and this inequity needs to change.”

Endometrial cancer is Australia’s most common reproductive cancer, with more than 50 women diagnosed every week.5 Around 20% of women are diagnosed at an advanced stage8 and of this group, only one in five survive beyond five years.6

Symptoms of endometrial cancer include abnormal vaginal bleeding, unexplained weight loss and abdominal pain.9 Increasing age is a prominent risk factor and while women are typically diagnosed around age 65, the disease can also present in younger women.9

Andrew Thomas, VP and General Manager of GSK Australia commented: “At GSK, endometrial cancer is a vital focus of our work in gynaecological cancers. We remain committed to providing innovative treatment options to support better outcomes for women living with this life-threatening condition.”

Jemperli is an immunotherapy that blocks a protein (known as PD-1) in immune cells, which helps the immune system fight cancer.1 It’s administered via a 30-minute infusion in the hospital with chemotherapy every three weeks for the first six doses, then every six weeks as a monotherapy.1

Like all medicines, Jemperli can cause side effects. Common side effects (when used with chemotherapy) include low thyroid hormone, rash, dry skin, fever, and raised liver enzymes.1 Serious side effects may include inflammation of the lungs, gut, liver, hormone glands, kidneys, skin, heart, brain, nerves, spinal cord, or eyes; immune-related reactions (e.g., GVHD after transplant); and allergic-type infusion reactions.1 The therapy should not be used during pregnancy/breastfeeding or in those with ingredient hypersensitivity.1

Jemperli is not listed on the Pharmaceutical Benefits Scheme (PBS) in combination with chemotherapy for the extended TGA approved indication relating to mismatch repair proficient (MMRp) endometrial cancer. Jemperli is reimbursed on the PBS for women with newly diagnosed primary advanced or recurrent endometrial cancer with mismatch repair deficiency (dMMR).10

Patients should always speak to their physician or oncologist for guidance on their appropriate treatment.

 

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Expanded TGA indication: JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

 

About Jemperli (dostarlimab)

Safety: Like all medicines, Jemperli can cause side effects. When Jemperli is given alone, commonly reported side effects can include a decrease in the number of red blood cells (anaemia), low levels of thyroid hormone, diarrhoea, nausea, vomiting, rash, itchy skin, fever, and increased liver enzyme levels in the blood.1 When Jemperli is given, in combination with chemotherapy (carboplatin and paclitaxel), common side effects can include low levels of thyroid hormone, rash, dry skin, fever, and increased liver enzyme levels in the blood.1 Serious side effects can include inflammation of the lungs, digestive tract, liver, hormone glands, kidneys, skin, heart muscle (myocarditis), brain and nervous system (myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, encephalitis), spinal cord (myelitis), eye, other organs, Infusion-related reactions may cause allergic-like reactions when they receive an infusion - these usually develop within minutes or hours but may develop up to 24 hours after treatment. Solid organ transplant rejection and other complications, including graft-versus-host-disease (GVHD), may occur in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

 Precautions: Patients should speak to their healthcare professional if they may be having an allergic reaction, experience any of the side effects listed above or any other side effects. Jemperli is unlikely to affect the ability to drive and use machines. However, people should be careful when driving or operating machines should they experience side effects that may affect the ability to concentrate and react. For more information, visit: https://au.gsk.com/media/6469/jemperlicmiau.pdf 

Contraindications: Allergy to Jemperli (dostarlimab) or inactive ingredients; Jemperli should not be used during pregnancy or breastfeeding.

 Interactions: The following active substances need to be considered by a healthcare professional with someone receiving Jemperli; dostarlimab (active ingredient) or sodium citrate dihydrate; citric acid monohydrate; arginine hydrochloride; sodium chloride; polysorbate 80; and water for injection (inactive ingredients). For more information, visit: https://au.gsk.com/media/6469/jemperlicmiau.pdf 

 

About endometrial cancer

Endometrial cancer, often referred to as uterine cancer, is the most frequently diagnosed gynaecological malignancy. It originates in the endometrium, which is the inner lining of the uterus. Symptoms of endometrial cancer include: post-menopausal bleeding (after one’s menstrual cycle has ceased for a year); abnormally heavy menstrual flow and spotting between periods; an odd vaginal discharge that may be watery, bloody, or have an odour; discomfort in the abdominal region; and difficulty or pain while urinating.9 As well as abnormal vaginal bleeding, unexplained weight loss and abdominal pain.11 Increasing age is a prominent risk factor and while women are typically diagnosed around age 65, the disease can also present in younger women.12

 

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.

 

References:

  1. Jemperli Consumer Medicine Information Summary, https://medsinfo.com.au/consumer-information/document/Jemperli_CMI#452982-body [Accessed April 2025].
  2. Mirza M et al. NEJM 2023; 388:2145-2158.2.
  3. Soumerai TE et al. Clin Cancer Res 2018; 24(23): 5939-5947.
  4. Corr B et al. BMJ Med 2022; 1(1):e000152.
  5. Australian Gynaecological Cancer Foundation. Looking closely at uterine or endometrial cancer Available: https://agcf.org.au/uterine-endometrial-cancer/ [Accessed April 2025].
  6. The Rise of Endometrial Cancer. Available: https://www.anzgog.org.au/the-rise-of-endometrial-cancer/#:~:text=Each%20year%2C%20more%20than%203%2C300,of%20over%2050%25%20by%202040 [Accessed April 2025].
  7. Jemperli Product Information Summary, https://au.gsk.com/en-au/media/press-releases/jemperli-dostarlimab-is-now-listed-on-the-pbs-in-combination-with-chemotherapy-as-a-first-line-treatment-for-women-with-dmmr-primary-advanced-or-recurrent-endometrial-cancer/ [Accessed April 2025].
  8. Memorial Sloan Kettering Cancer Center. Stages of Uterine (Endometrial) Cancer. Available: https://www.mskcc.org/cancer-care/types/uterine-endometrial/diagnosis/stages [Accessed April 2025]
  9. Cancer Council. Types of Cancer: Uterine cancer. https://www.cancer.org.au/cancer-information/types-of-cancer/uterine-cancer [Accessed April 2025]
  10. The Pharmaceutical Benefits Scheme (PBS). Recommendations made by the PBAC – Nov 2023 Available from: https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/pbac-outcomes [Accessed April 2025].
  11. Australian Government Cancer Australia. What are the risk factors for endometrial cancer? https://www.canceraustralia.gov.au/cancer-types/endometrial-cancer/what-are-risk-factors-endometrial-cancer [Accessed April 2025]
  12. Endometrial Cancer, The Royal Women’s Hospital, https://www.thewomens.org.au/health-information/womens-cancers-pre-cancers/endometrial-cancer [Accessed April 2025].

For product information please contact GlaxoSmithKline Australia Pty Ltd. 3/436 Johnston St, Abbotsford VIC 3067. ABN 47 100 162 481. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK or Medical Information on 1800 033 109. JEMPERLI (dostarlimab) Trademarks are owned by or licensed to the GSK group of companies ©2025 GSK group of companies or its licensor. Date of approval: April 2025. PM-AU-DST-PRSR-250001.