Abstract

HER2 mutations are an established molecular target in NSCLC; however, there are no approved therapies for pts with HER2m NSCLC. T-DXd is an antibody-drug conjugate consisting of an anti-HER2 antibody, cleavable linker, and topoisomerase I inhibitor payload. T-DXd is approved globally at a dose of 5.4 mg/kg every 3 weeks (Q3W) in patients with HER2+ metastatic breast cancer and in the US/Japan at 6.4 mg/kg Q3W in patients with HER2+ metastatic gastric cancer. In a ph 2 trial (DESTINY-Lung01; NCT03505710) in pts with relapsed/refractory HER2m NSCLC, who received T-DXd 6.4 mg/kg Q3W, the confirmed objective response rate (ORR) was 61.9% and the median progression-free survival (PFS) was 14 months at the interim analysis (Smit ASCO 2020).

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