The next Keytruda vs Jemperli battle

GSK has been carving out a niche for Jemperli in endometrial carcinoma, but Merck & Co has other plans. The latter company today disclosed the acceptance of a US filing, based on a little-known NCI-sponsored phase 3 trial called Keynote-868, that will seek to give Keytruda a monopoly on broad first-line treatment of this cancer. Keytruda was the first anti-PD-(L)1 drug to secure an endometrial carcinoma approval, as part of a Lenvima combo in second-line mismatch repair (MMR) proficient disease. GSK countered with a second-line approval for Jemperli in MMR-deficient disease, a label Keytruda then matched. GSK’s latest salvo was last year’s approval of a Jemperli chemo combo in first-line MMR-deficient endometrial carcinoma, based on the phase 3 Ruby trial, which later read out positively for overall survival in MMR-proficient disease too. But, while GSK said data would be shared with regulators, it hasn’t disclosed a filing in first-line MMR-proficient endometrial carcinoma, while today Merck said its Keytruda filing was agnostic of MMR status. In Keynote-868 Keytruda plus chemo hit statistical significance on PFS versus chemo in MMR-proficient (HR=0.54) and deficient (HR=0.30) endometrial carcinoma. The FDA’s action date is 21 June.

Keytruda vs Jemperli in endometrial carcinoma

Source: OncologyPipeline. This story has been correct to state that PFS was the primary endpoint of Keynote-868.