Jemperli receives positive funding recommendations from CDA-AMC and INESSS in all adult patients with primary advanced or first recurrent endometrial cancer
- Canada's Health Technology Assessment (HTA) agencies affirm the clinical value of Jemperli across all patients, irrespective of MMR/MSI status, offering renewed hope to those with MMRp/MSS endometrial cancer while building on its established benefit for dMMR/MSI-H populations.
- HTA recommendation marks an important step toward securing public funding for eligible patients in Canada, with provincial and territorial governments ultimately responsible for making the final decision on public coverage.
MISSISSAUGA, ON – GSK is pleased to announce that Jemperli (dostarlimab for injection) has received positive reimbursement recommendations with conditions from Canada’s HTA bodies, CDA-AMC and INESSS. Both agencies recommend that Jemperli, combined with chemotherapy (carboplatin and paclitaxel), be reimbursed for treating all adult patients with primary advanced or first recurrent endometrial cancer, irrespective of mismatch repair/microsatellite instability (MMR/MSI) status, who are candidates for systemic therapy. This recommendation follows Health Canada’s approval of this expanded indication of Jemperli in April 2025, which includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.
“Endometrial cancer remains a challenging disease where there is a critical need for treatments that improve survival, delay disease progression, and enhance quality of life,” says Dr. Lesley Roberts, Gynecologic Oncologist and Advocacy Director, The Society of Gynecologic Oncology of Canada (GOC). “For patients with MMRp tumours, the unmet need is particularly striking. These recommendations represent a significant development for patients across Canada, providing renewed hope for those battling advanced or recurrent endometrial cancer. Prioritizing timely access to innovative therapies like this is critical to transforming patient outcomes.”
Since Health Canada approval in November 2023, Jemperli has evolved the standard of care in mismatch repair deficient/microsatellite instability high (dMMR/MSI-H) tumours achieving public funding in the majority of provinces in record time compared to industry benchmarks. The latest reimbursement recommendations underscore Jemperli’s value as the first and only immuno-oncology therapy to show an overall survival benefit in combination with carboplatin and paclitaxel in patients with primary advanced and first recurrent endometrial cancer, including both dMMR/MSI-H and MMRp/MSS tumours. MMRp/MSS tumours represent approximately 75% [i] of patients diagnosed with endometrial cancer, a group that has historically faced poor outcomes and limited treatment options.
The CADTH and INESSS recommendations for reimbursement of Jemperli’s expanded indication is supported by the results from Part 1 of the RUBY phase III trial. RUBY Part 1 met its dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS) in the overall population of patients with primary advanced or recurrent endometrial cancer, and is the only clinical trial in this setting to show a clinically meaningful and statistically significant OS benefit, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54–0.89, p=0.002, n=494) compared to chemotherapy alone.
"These recommendations are a pivotal step toward improving access to innovative treatments and outcomes for primary advanced and recurrent endometrial cancer patients” said, Michelle Horn, Country Medical Director at GSK Canada. “At GSK, we are committed to collaborating with all stakeholders to accelerate reimbursement processes, ensuring timely access for patients where every moment matters."
Full details on reimbursement recommendations, including clinical criteria and conditions, can be accessed on the CDA-AMC and INNESS websites.
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,[ii] with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.[iii] Incidence rates are expected to rise by approximately 40% between 2020 and 2040.[iv] In Canada, an estimated 8,600 women were diagnosed with endometrial cancer in 2024, with approximately 1,600 succumbing to the disease.[v] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[vi] Among patients with primary advanced or recurrent endometrial cancer, approximately 75% have MMRp/MSS tumours.[i]
About RUBY
RUBY is a two-part global, randomized, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 evaluated dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo 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 dMMR/ 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 494 patients in efficacy analyses across a broad population, including histologies often excluded from clinical trials (approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma).
About Jemperli (dostarlimab for injection)
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. [vii]
In Canada, Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy. This includes patients with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved 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.
Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.
GSK in gynaecologic oncology
GSK is committed to maximizing patient survival through transformational medicines with a current effort on breakthroughs in oncology, including gynaecologic cancers, some of the most common cancers affecting women. We are focused on developing new medicines across a range of different modalities for a variety of cancers, including ovarian and endometrial.
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 www.ca.gsk.com/en-ca.
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 in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025.
References
i. Based on CMP:CancerMPact® [Patient Metrics], Cerner Enviza. Available from www.cancermpact.com. Accessed 18 March 2025.
ii. Faizan U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available at: nlm.nih.gov/books/NBK562313/.
iii. 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.
iv. International Research on Cancer. Global Cancer Observatory. Cancer Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 18 March 2025.
v. Lee, S. (2024). Uterine cancer statistics. Canadian Cancer Society. https://cancer.ca/en/cancer-information/cancer-types/uterine/statistics.
vi. CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza. Available at www.cancermpact.com. Accessed 18 March 2025.
vii. Laken H, Kehry M, Mcneeley P, et al. Identification and characterization of TSR-042, a novel anti-human PD-1 therapeutic antibody. European Journal of Cancer. 2016;69,S102. doi:10.1016/s0959-8049(16)32902.
