
Merck’s 299-patient Keytruda trial meets PFS endpoint
- Merck said Keytruda monotherapy significantly improved progression-free survival compared with platinum-doublet chemotherapy in Phase 3 KEYNOTE-C93.
- Merck shares were down 2.6% at $120.78 following the announcement.
- Merck plans to present the complete results at a medical meeting and share them with regulatory authorities.
Merck (NYSE:MRK) said its 299-patient KEYNOTE-C93 trial met its PFS endpoint for Keytruda monotherapy versus chemotherapy in dMMR endometrial cancer.
The result could support a chemotherapy-free frontline option, although Merck has not disclosed the hazard ratio, median PFS or response percentages.
“These findings build upon the well-established role of KEYTRUDA in endometrial cancer,” said Merck Research Laboratories Vice President Dr. Gursel Aktan.
Patients received Keytruda 400 mg every six weeks for up to 18 cycles or carboplatin-paclitaxel every three weeks for six cycles.
Following the announcement, Merck's share price was down 2.6% at $120.78.
The FDA already permits Keytruda in several endometrial-cancer settings, including first-line combination therapy and later-line monotherapy for MSI-H or dMMR disease.
Merck is also studying sacituzumab tirumotecan after TroFuse-005 met PFS, OS and response endpoints in previously treated endometrial cancer patients.