Jemperli (dostarlimab for injection) plus carboplatin and paclitaxel approved in Canada as a treatment option for primary advanced or recurrent dMMR/MSI-H endometrial cancer

16 Nov 2023
www.biospace.com
Drug ApprovalPhase 3Priority ReviewASCOAccelerated Approval
[16-November-2023] Jemperli is the only immuno-oncology treatment approved for this patient population in combination with chemotherapy in Canada. An estimated 20-29% of all endometrial cancers are dMMR/MSI-H and patients face significant unmet need experiencing poor long-term outcomes with the current standard of care. [7] MISSISSAUGA, ON, Nov. 16, 2023 /CNW/ - GSK today announced that Health Canada has approved a new indication for Jemperli (dostarlimab for injection) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy, based on Part 1 of the pivotal RUBY study. [1] "Today's approval supports our ambition for Jemperli to advance the standard of care for Canadian adult patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer," said Marni Freeman, Country Medical Director at GSK Canada. "This expanded approval of Jemperli offers a new care option to healthcare professionals treating this patient population with high unmet need." In December 2021, Jemperli had previously been granted Notice of Compliance with conditions by Health Canada as a monotherapy for the treatment of adult patients with dMMR or MSI-H recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum containing regimen. "The Society of Gynecologic Oncology of Canada (GOC) proudly supports the inclusion of medications like dostarlimab, recognizing their potential to provide patients with valuable choices, prolong survival, and ultimately benefit women battling cancer," expressed Dr. Alon Altman, President, The Society of Gynecologic Oncology of Canada. "We believe in the importance of a diverse and comprehensive approach to treatment, and we commend the efforts of all involved in advancing innovative solutions for women's health. Our organization remains committed to advocating for initiatives that enhance the well-being of women affected by gynecologic cancers." Today's new indication for Jemperli was approved by Health Canada following review under Health Canada's Priority Review policy and the Project Orbis framework of the US Food and Drug Administration (FDA) Oncology Center of Excellence, which is an international partnership designed to give cancer patients faster access to promising cancer treatments, allowing concurrent submission to and review among regulatory authorities in the US, Australia, Canada, Switzerland, Singapore and United Kingdom. "Endometrial cancer is the most common gynecologic cancer in Canada, and there have been limited new treatment options for patients over the past few decades," said Jackie Manthorne, President, and CEO of the Canadian Cancer Survivor Network (CCSN). "The CCSN is pleased to see a newly approved innovative treatment option for patients in Canada. We hope that new treatments like dostarlimab will not be delayed by our Canadian reimbursement and funding systems. Patients shouldn't have to wait, because cancer certainly can't wait!" The new expanded approval in Canada is supported by interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The RUBY trial data were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on March 27, 2023, and were simultaneously published in The New England Journal of Medicine.[2] About endometrial cancer Endometrial cancer is one of the most common gynaecologic cancers in developed countries,[3] and there are about 8,100 new cases of endometrial cancer diagnosed every year in Canada [4]. Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. [5] [6] An estimated 20-29% of all endometrial cancers are dMMR/MSI-H. [7] Chemotherapy has been the current standard of care for the majority of patients with primary advanced or recurrent endometrial cancer, and many patients eventually experience disease progression. [8] 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 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 analyses of PFS in the dMMR/MSI-H and 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 populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials such as carcinosarcoma and 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. [9] In Canada, Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy, and as monotherapy for the treatment of adult patients with dMMR or 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 for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. GSK in oncology GSK is committed to maximizing patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumor-cell targeting therapies, and development in haematologic malignancies, gynaecologic cancers and other solid tumours. 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.ca. SOURCE GlaxoSmithKline Inc.
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