The U.S. FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations, following progression on tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy

Sac-TMT is an investigational antibody-drug conjugate (ADC) targeting TROP2, being developed in collaboration with Kelun-Biotech, with data from Phase 1/2 studies supporting its potential

Breakthrough Therapy designation is intended to expedite the development of treatments for serious conditions, providing more intensive guidance from the FDA and potential eligibility for Priority Review

Merck is advancing a global clinical development program for sac-TMT, including ongoing Phase 3 studies in various solid tumors, such as TroFuse-004 and TroFuse-009, focusing on EGFR-mutated NSCLC

Sac-TMT recently received marketing authorization in China for the treatment of advanced metastatic triple-negative breast cancer (TNBC) in patients with prior systemic therapies, under a collaboration agreement with Kelun-Biotech for development and commercialization in Greater China