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CHMP Recommends GSK's Jemperli Plus Chemo as Frontline Endometrial Cancer Treatment in Europe

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Monday recommended that regulators approve GlaxoSmithKline's PD-1 inhibitor Jemperli (dostarlimab) plus chemotherapy for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-high) advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The committee's opinion is based on results from the Phase III RUBY trial comparing Jemperli plus chemo versus chemo alone as a frontline treatment in this subset of patients. In the study, 61.4 percent of patients with dMMR or MSI-high endometrial cancer did not progress at 24 months in the Jemperli-chemo arm, compared to 15.7 percent in the chemo arm. GSK said in a statement that the RUBY trial met its primary endpoint of investigator-assessed progression-free survival. An exploratory overall survival analysis in the study also showed that the addition of Jemperli to chemo led to a 70 percent reduction in the risk of death versus chemo alone.

In Europe, Jemperli has conditional approval as a monotherapy for dMMR or MSI-high advanced endometrial cancer patients who have received prior treatment with a platinum-containing regimen. If the European Commission decides to approve the latest application, it would expand Jemperli's indication to the first-line setting in endometrial cancer in the EU. GSK is expecting regulators in Europe to issue a decision by the end of this year.

In July, the US Food and Drug Administration granted approval to the Jemperli-chemo combination in this same indication. Jemperli is also approved in the US as a monotherapy treatment for dMMR or MSI-high advanced endometrial cancer patients who have had prior chemotherapy.