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.
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