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Lynparza’s endometrial cancer first comes in the EU

EU approval for first-line endometrial cancer of AstraZeneca’s Imfinzi plus chemo – as well as of an Imfinzi plus Lynparza combo – means that European doctors will face a different treatment choice versus their US counterparts. In the US the battle is between Merck & Co’s Keytruda and GSK’s Jemperli, both of which are approved irrespective of patients’ mismatch repair (MMR) status. But the FDA refused to endorse Imfinzi plus Lynparza in MMR-proficient disease, in June backing Imfinzi plus chemo in MMR-deficient endometrial cancer only, based on a subgroup analysis of the Duo-E trial. The EMA, however, has gone with the CHMP recommendation to approve both this, and Imfinzi/chemo followed by the Imfinzi/Lynparza combo in MMR-proficient disease, even though the Duo-E result was clearly driven by MMR-deficient patients. To complicate matters further, Keytruda’s chemo combo isn’t available in any first-line endometrial cancer setting in the EU, and Merck appears not to be pursuing this use outside the US, where the FDA issued it a broad green light on the basis of the NCI-sponsored Keynote-868 trial. For its part, Jemperli has broad US approval, but the EMA has yet to decide on its use in first-line MMR-proficient endometrial cancer.

 

How the first-line endometrial cancer dynamic has split


 

MMR-deficient

MMR-proficient


 

US

EU

US

EU

Jemperli (GSK)Chemo combo, followed by monotherapy, approved based on RubyChemo combo, followed by monotherapy, approved based on RubyAccepted for review in Jun 2024, with decision expected in 2025
Keytruda (Merck & Co)Chemo combo, followed by monotherapy, approved based on Keynote-868Not approvedChemo combo, followed by monotherapy, approved based on Keynote-868Not approved
Imfinzi (AstraZeneca)Chemo combo, followed by monotherapy, approved based on Duo-ENot approvedChemo combo, followed by Lynparza combo, approved based on Duo-E

Source: OncologyPipeline.

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