Trastuzumab deruxtecan in HER2 -mutant non–small-cell lung cancer

New England Journal of MedicineLi BT, Smit EF, Goto Y, et al. | September 21, 2021


Findings demonstrate durable anticancer activity of trastuzumab deruxtecan (formerly DS-8201), a human epidermal growth factor receptor 2 (HER2) antibody–drug conjugate, in patients with previously treated HER2-mutant non–small-cell lung cancer (NSCLC), and the associated toxic impacts were generally consistent with those in prior reported studies.

  • This multicenter, international, phase 2 study comprised 91 patients with metastatic HER2-mutant NSCLC refractory to standard treatment.

  • These patients received trastuzumab deruxtecan (6.4 mg per kilogram of body weight).

  • Centrally confirmed objective response was achieved in 55% of the patients, and median duration of response was 9.3 months.

  • Median progression-free survival and median overall survival were 8.2 and 17.8 months, respectively.

  • 46% of patients suffered grade 3 or higher drug-related adverse events; neutropenia was the most common event (in 19%).

  • 26% of patients suffered from adjudicated drug-related interstitial lung disease which caused death in 2 patients.

  • Across different HER2 mutation subtypes and in cases with no detectable HER2 expression or HER2 amplification, responses were noted.

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