GSK’s Jemperli▼ (dostarlimab) is accepted for use within NHS Scotland, in line with its licence, in eligible endometrial cancer patients in first line setting

• Clinicians in Scotland will now be able to use dostarlimab in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.[i]
• Approximately 740 new cases of endometrial cancer are diagnosed in Scotland each year.ⁱⁱ An estimated 240 of these will be advanced or recurrent disease.[ii]
• Following this decision by the Scottish Medicines Consortium (SMC), approximately 50 patients per year in Scotland could be eligible for treatment with dostarlimab.ⁱⁱ

GSK plc (LSE/NYSE: GSK) today announced that the Scottish Medicines Consortium (SMC) has accepted dostarlimab for use within NHS Scotland in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.ⁱ

In Scotland, there are approximately 240 people diagnosed with advanced or recurrent disease each year, of which an estimated 50 per year will now be eligible for treatment with dostarlimab.ⁱⁱ This decision means that dostarlimab is the first immunotherapy treatment to be accepted for use within NHS Scotland for this group of eligible patients.

Dr Alison Stillie, Consultant Clinical Oncologist at the Edinburgh Cancer Centre, said: “The SMC’s approval of dostarlimab, in combination with chemotherapy for eligible endometrial cancer patients with dMMR/MSI-H primary advanced or recurrent disease, is welcome news. This will give selected patients across Scotland, who have been faced with limited treatment options, the potential to access this treatment in the first line setting.”

Endometrial cancer, a form of uterine cancer that starts in the lining of the endometrium (womb), is the most common gynaecological cancer in the UK, with rising incidence and mortality rates.[iii]^,[iv]^,[v] Over the last decade in the UK (between 2006-2008 and 2016-2018), uterine cancer age standardised incidence rates for females increased by 12%.^v Despite advances in medical science, outcomes of advanced and recurrent endometrial cancer remain poor.[vi] The median overall survival of people with advanced or recurrent endometrial cancer is reported to be less than three years when treated with standard of care platinum-based chemotherapy.[vii]

Mark Toms, Vice President Medical Affairs and UK Country Medical Director, GSK, said: “For many years, there has been little advancement in endometrial cancer treatment, with clinicians having few options for their patients. At GSK, we aspire to improve outcomes for people living with cancer, particularly those with unmet needs. We are proud of our collaborative work with NHS Scotland and SMC stakeholders and are delighted by today’s news, which may provide eligible Scottish patients with the opportunity to access this treatment in the first line setting.”

The SMC decision follows recently published final draft guidance by the National Institute for Health and Care Excellence (NICE) which provided access to dostarlimab, in line with its licence, for eligible patients in England, Wales and Northern Ireland.[viii] Dostarlimab has been licensed in the UK since 2022, as monotherapy for treatment of adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer following prior platinum-based chemotherapy, available on the NHS in England via the Cancer Drugs Fund (CDF).[ix]

About endometrial cancer

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecological cancer in developed countries, with approximately 420,000 new cases reported worldwide in 2022.[x]

About dostarlimab[xi]

Dostarlimab is indicated:

• in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
• as 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.

The Great Britain Marketing Authorisation granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) was based on pivotal data from Part 1 of the Phase III randomised, double-blind RUBY study, which evaluated dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer.

In Northern Ireland, Marketing Authorisation was provided by the European Medicines Agency (EMA). In Europe, dostarlimab is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with dMMR/MSI‑H primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.[xii]

About RUBY Part 1^vii

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. The dual-primary endpoints in Part 1 are investigator-assessed progression-free survival (PFS) based on the Response Evaluation Criteria in Solid Tumours v1.1 and overall survival (OS). The statistical analysis plan included pre-specified primary analysis of PFS in the dMMR/MSI-H and intent-to-treat (ITT) populations and OS in the overall population. Pre-specified exploratory analyses of PFS in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) population and OS in the dMMR/MSI-H and MMRp/MSS populations were 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.

Secondary endpoints in Part 1 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, time to second objective disease progression (PFS2), patient-reported outcomes, and safety and tolerability. The safety and tolerability profile of dostarlimab in combination with carboplatin-paclitaxel in the RUBY phase III trial was generally consistent with the known safety profiles of the individual agents. Adverse events of any grade occurring in >20% of the overall population in either arm were fatigue, alopecia, nausea, peripheral neuropathy, anaemia, arthralgia, constipation, diarrhoea, myalgia, hypomagnesaemia, peripheral sensory neuropathy, decreased appetite, dyspnoea and rash. Any ≥grade 3 treatment emergent adverse events (TEAE) and any serious adverse event were approximately 10% higher in the dostarlimab plus carboplatin-paclitaxel arm, compared with the placebo plus carboplatin-paclitaxel arm, in the overall population. The incidence of grade 3 or higher adverse events occurred in 170 (70.5%) patients in the treatment arm compared to 147 (59.8%) in the control arm. Serious adverse events occurred in 91 (37.8%) patients in the treatment arm compared to 68 (27.6%) in the control arm.

Refer to the dostarlimab Summary of Product Characteristics (SmPC) for a full list of adverse events and the complete important safety information.^xi

GSK in oncology

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. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, and antibody-drug conjugates, either alone or in combination.

About GSK

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[i] SMC Advice. Data on file. REF-226481.

[ii] GSK Data on file. REF-218017.

[iii] NIH. Rising Endometrial Cancer Rates Spur New Approaches to Prevention. Available at: https://prevention.cancer.gov/news-and-events/blog/rising-endometrial-cancer-rates-spur-new-approaches-prevention. Last accessed April 2024.

[iv] The Royal Marsden NHS Foundation Trust. Q&A: Gynaecological cancers. Available at: https://www.royalmarsden.nhs.uk/gp-update/qa-gynaecological-cancers. Last accessed April 2024.

[v] Cancer Research UK. Uterine cancer statistics. Available at https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/uterine-cancer#heading-One. Last accessed April 2024.

[vi] Oaknin A, et al. Endometrial cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022;33(9):860–877.

[vii] Mirza MR, et al. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2145-2158. doi: 10.1056/NEJMoa2216334.

[viii] NICE Final Draft Guidance. Available at: https://www.nice.org.uk/guidance/gid-ta10850/documents/674. Last accessed April 2024.

[ix] NICE. Dostarlimab for previously treated advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency. Available at: https://www.nice.org.uk/guidance/ta779. Last accessed. Last accessed April 2024.

[x] World Health Organisation International Agency for Research on Cancer (IARC). GLOBOCAN 2024: Corpus Uteri Factsheet. Available at: https://gco.iarc.fr/today/en/dataviz/tables?mode=population&cancers=24. Last accessed April 2024.

[xi] Dostarlimab Summary of Product Characteristics. Great Britain.

[xii] European Medicines Agency. Authorisation Details. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli#authorisation-details. Last accessed April 2024.