Merck's TROP2 ADC Cuts Death Risk 32% in Endometrial Cancer; FDA Sets June 2027 PDUFA
MRK sits 73% above its 52-week low of $82.01 on light trading volume (0.3× avg).
Summary
Merck's sacituzumab tirumotecan hit both survival endpoints in the Phase 3 TroFuse-005 trial in previously treated endometrial cancer: median overall survival of 19.0 months versus 12.1 months on chemo (HR 0.68, a 32% cut in risk of death) and progression-free survival of 7.2 versus 3.9 months (HR 0.59). Response rates were 35.1% versus 17.3%. The FDA accepted the filing under priority review with a PDUFA target of June 15, 2027, putting a US launch decision roughly eight months out. Safety is the caveat: Grade ≥3 treatment-related adverse events ran 54.4% versus 41.4%, which could shape the label and how quickly physicians adopt it. This is the first Phase 3 confirmation of an OS benefit for the program and widens Merck's oncology footprint beyond Keytruda, with 18 Phase 3 trials still running across indications.
At the time of this announcement, MRK was trading at $141.73 on NYSE in the Life Sciences sector, with a market capitalization of approximately $349.7B. The 52-week trading range was $82.01 to $156.92. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.