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 2nd-line1st-lineMSI-low/MMR-proficientKeytruda + Lenvima approved (Keynote-146 & 775)Keytruda + chemo filed, 21 Jun 2024 PDUFA (Keynote-868)N/A for JemperliJemperli + chemo “clinically meaningful” OS (Ruby)MSI-high/MMR-deficientJemperli monotherapy approved (Garnet)Jemperli + chemo approved (Ruby)Keytruda monotherapy approved (Keynote-158)Keytruda + chemo filed, 21 Jun 2024 PDUFA (Keynote-868)Source: OncologyPipeline. This story has been correct to state that PFS was the primary endpoint of Keynote-868.
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
| 2nd-line | 1st-line |
|---|
| MSI-low/MMR-proficient | Keytruda + Lenvima approved (Keynote-146 & 775) | Keytruda + chemo filed, 21 Jun 2024 PDUFA (Keynote-868) |
| N/A for Jemperli | Jemperli + chemo “clinically meaningful” OS (Ruby) |
| MSI-high/MMR-deficient | Jemperli monotherapy approved (Garnet) | Jemperli + chemo approved (Ruby) |
| Keytruda monotherapy approved (Keynote-158) | Keytruda + chemo filed, 21 Jun 2024 PDUFA (Keynote-868) |
