The approval was supported by interim analysis findings from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 study in which the combination met the primary endpoint of overall survival
GSK announced that Health Canada has approved Jemperli (dostarlimab for injection) in combination with carboplatin and paclitaxel to treat certain adult patients with endometrial cancer.
Jemperli is a trained death receptor-1 (PD-1)-blocking antibody. It is designed to bind to the PD-1 receptor and inhibit its interaction with the PD-1 ligands PD-L1 and PD-L2.
The Jemperli combination is now approved in Canada to treat adults with primary advanced or recurrent mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) endometrial cancer who are eligible for systemic therapy, based on Part 1 of the RUBY trial.
GSK Canada country medical director Marni Freeman said: “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.
“This expanded approval of Jemperli offers a new care option to healthcare professionals treating this patient population with high unmet need.”
Jemperli was previously granted a Notice of Compliance with conditions by Health Canada in December 2021.
It was intended for the PD-1-blocking antibody as a monotherapy to treat patients with dMMR or MSI-H recurrent or advanced endometrial cancer that has grown on or after platinum-containing regimen treatment.
The latest indication was approved 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.
It was supported by interim analysis findings from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 study in which the combination met the primary endpoint of overall survival (OS).
RUBY is a two-part global, randomised, double-blind, multicentre late-stage study of adults with primary advanced or recurrent endometrial cancer.
The dual-primary endpoints in Part 1 are defined as OS and the investigator-assessed progression-free survival (PFS) as per the Response Evaluation Criteria in Solid Tumours v1.1.
In Canada, Jemperli is said to be the only immuno-oncology therapy in combination with chemotherapy cleared for this patient category.