GSK announced that Health Canada granted full approval for Jemperli (dostarlimab for injection) as a 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.
"We remain committed to exploring the full potential of Jemperli as the foundation of our immuno-oncology portfolio, aiming to meet the needs of patients in various stages of endometrial cancer and other types of solid tumors," said Marni Freeman, Country Medical Director at GSK Canada. "This approval in Canada reaffirms our belief in the value of Jemperli as a treatment choice for patients who are living with dMMR/MSI-H recurrent or advanced endometrial cancer."
This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial, a phase I, multicenter, open-label, single-arm study of Jemperli monotherapy in patients with advanced or recurrent solid tumors. Confirmed objective response rate (ORR) was 45.5% (95% CI: 37.1, 54.0), and the median duration of response (DOR) was not reached (range: (1.18+, 47.21+months), with a median follow-up for duration of response of 27.6 months.
In December 2021, Jemperli was granted NOC/c by Health Canada as a monotherapy for this indication in 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. Additionally, in November 2023, Jemperli in combination with carboplatin and paclitaxel was approved in Canada as a treatment option in combination with carboplatin and paclitaxel for adult patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer in patients who are candidates for systemic therapy. Jemperli in combination with carboplatin and paclitaxel recently received positive funding recommendations from Canada's health technology assessment bodies and the file is now under active negotiation with the pan-Canadian Pharmaceutical Alliance (pCPA). GSK is committed to working with the pCPA and the drug programs to support widespread and timely access for primary advanced and recurrent endometrial cancer patients.
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