Efficacy and safety of TROP2 antibody-drug conjugate-containing regimen in the patients with HER2 negative metastatic breast cancer and advanced non-small-cell lung cancer.

The aim of this study is to evaluate the efficacy and safety of TROP2 antibody-drug conjugate (ADC) -based regimen in the treatment of HER2-negative advanced breast cancer and non-small cell lung cancer (NSCLC) in real environment to fill the evidence gap. A total of 130 patients (median age 55 years) were included in the study. The median progression-free survival (mPFS) of 75 NSCLC patients was 10.0 (95%CI: 5.130-14.870) months. The mPFS of 21 hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer (BC) patients was 6.0 (95%CI: 4.217-7.783) months. The mPFS of 34 triple-negative breast cancer (TNBC) patients was 5.0 (95%CI: 2.845-7.158) months. In patients with TNBC, mPFS was significantly shorter with sacituzumab govitecan monotherapy than with sacituzumab tirumotecan monotherapy (2.0 months vs 6.0 months, p = 0.036). In patients with NSCLC, mPFS was significantly longer in those receiving sacituzumab tirumotecan monotherapy as first-and second-line therapy than in those receiving third-line or more therapy (17.0 vs 7.0 months, p = 0.0026). The incidence of adverse events was 63.8% (≥ grade 3 accounted for 38.5%), mainly anemia, leukopenia, etc. The existing evidence suggests that TROP2 ADC has certain anti-tumor activity in advanced HER2-negative breast cancer and NSCLC, which provides limited support for its exploration in first-line combination and early treatment. However, the actual improvement effect on survival endpoints is still unclear and needs to be verified by large prospective phase III studies. At the same time, long-term safety signals and acquired drug resistance also need continuous attention.