The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of Jemperli®▼ (dostarlimab) with platinum-based chemotherapy for first-line treatment of primary advanced or recurrent endometrial cancer with mismatch repair proficiency or microsatellite stability.1
In England, there are 8,200 cases of endometrial cancer annually, with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours approximately accounting for three out of every four cases (72%).2,3
Today’s approval broadens the previous NICE recommendation for dostarlimab across England, where more patients living with primary advanced or recurrent endometrial cancer may now be eligible for dostarlimab as a first-line treatment option.1
Based on part one of the RUBY phase III clinical trial, dostarlimab in combination with chemotherapy significantly improved median overall survival (OS) in the overall population of the trial to 44.6 months compared to 28.2 months for chemotherapy alone, demonstrating a 31% reduction in risk of death.4
The study population of part one of the RUBY trial reflected the target primary advanced or recurrent endometrial cancer patient group, with approximately 76% being diagnosed with mismatch repair proficient or microsatellite stable (MMRp/MSS) disease.4
Endometrial cancer, which starts in the lining of the womb (endometrium), is the most common gynaecological cancer in the UK.5
Since 1990, there has been around a 60% increase in incidence, largely due to lifestyle factors, such as obesity and an ageing population.6
Despite advances in medical science, the prognosis for people diagnosed with advanced stage endometrial cancer is extremely poor.7,8
The median overall survival of women with recurrent endometrial cancer is reported to be less than 12 months, with approximately 17% of women diagnosed at late stage with distant metastases surviving to five years.8,9
The Medicines and Healthcare products Regulatory Agency (MHRA) extended the licence of dostarlimab to patients living with primary advanced or recurrent endometrial cancer with mismatch repair proficiency or microsatellite stability (MMRp/MSS) in December 2024. Until then it was licensed for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer.
Following the NICE decision, GSK is working with relevant health authorities in Wales and Northern Ireland to ensure expanded access for more patients across the United Kingdom in this first-line setting.
GSK is now collaborating with stakeholders to provide access to patients in Scotland and has submitted a dossier to the Scottish Medicines Consortium (SMC) in preparation for appraisal.
Dr Eleanor Jones, Specialist Registrar in Obstetrics and Gynaecology and Chair of Trustees of Peaches Womb Cancer Trust, said: “Today’s decision is very welcome news for patients living in England. This news will mean that all eligible patients with primary advanced or recurrent endometrial cancer will now have the option of this additional treatment, where previously only some did. There are very few effective cancer treatment options for people with primary advanced and recurrent endometrial cancer, so access to this innovative first-line treatment fills an unmet need. Peaches Womb Cancer Trust has welcomed the opportunity to contribute to appraisals of dostarlimab. We could not have done so without the contributions of Peaches Patient Voices, a group of people affected by womb cancer whose powerful testimonies and experiences informed our submissions.”
References:
1. Draft Guidance available on the NICE website
2. NHS England. Cancer Registration Statistics, England, 2022 – NHS England Digital C54.1. Available at https://digital.nhs.uk/data-and-information/publications/statistical/cancer-registration-statistics/england-2022. Last accessed: November 2025
3. Eskander R.N., Sill M.W., Beffa L., et.al. Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer.” N. Engl. J. Med. 2023 Jun 8;388(23):2159-2170. doi:10.1056/NEJMoa2302312. PMID: 36972022. Available at https://www.nejm.org/doi/full/10.1056/NEJMoa2302312 . Last accessed: November 2025.
4. Powell M.A. 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. In Press. 9 June 2024. Doi: 10.1016/j.annonc.2024.05.546. Last accessed: November 2025.
5. Royal Marsden NHS. Q&A Gynaecological cancers. Available at: https://bit.ly/3FIAojd. Last accessed: November 2025.
6. Cancer Research UK. Uterine cancer incidence by gender and UK country. Available at https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/uterine-cancer/incidence. Last accessed: November 2025.
7. Cancer Research UK. Survival For Womb Cancer. Survival For Womb Cancer | Cancer Research UK. Last accessed: November 2025.
8. Arezzo F, Giannone G, Castaldo D et al.,Management of metastatic endometrial cancer: physicians’ choices beyond the first line after approval of checkpoint inhibitors. Front. Oncol. 2023 Sept 14;13:1247291. doi:10.3389/fonc.2023.1247291. PMID: 37781174. Last accessed: November 2025.
9. Legge, F, Restanio S, Leone L et al., Clinical Outcome of recurrent endometrial cancer: analysis of patterns of recurrence and survival. Gynecol. Oncol. 2020 30(2):193-200. https://doi.org/10.1136/ijgc-2019-000822. Last accessed: November 2025.
