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An experimental antibody-drug conjugate from Merck and China-based Kelun-Biotech succeeded in a global Phase 3 study for the first time, giving Merck a key pipeline victory as it approaches the patent cliff for its best-selling immunotherapy Keytruda.
The ADC, known as sacituzumab tirumotecan or sac-TMT, had previously succeeded in a Phase 3 China-only study. But Monday’s win — in certain patients with advanced endometrial cancer — represents the first opportunity for sac-TMT to face US regulators. The therapy had received a voucher under former FDA Commissioner Marty Makary’s national priority program to speed review times, potentially putting an approval on the table sometime this year.