Merck: FDA grants Breakthrough Therapy designation to sacituzumab tirumotecan

Merck (MRK) announced that the U.S. FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer with epidermal growth factor receptor mutations whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy. Sac-TMT is an investigational trophoblast cell-surface antigen 2-directed antibody drug conjugate being developed in collaboration with Kelun-Biotech. This designation is based on data from the Phase 2 expansion cohort of a Phase 1/2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC, which were presented at the 2023 American Society of Clinical Oncology Annual Meeting, as well as data from two parts of a Phase 2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC who have been treated with at least two lines of prior therapy.