The following is a summary of “Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2–Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial,” published in the May 2023 issue of Oncology by Nishikawa, et al.

For a study, researchers sought to investigate the effectiveness and safety of trastuzumab deruxtecan, an antibody-drug conjugate that targets human epidermal growth factor receptor 2 (HER2), in patients with uterine carcinosarcoma (UCS) who express HER2.

The study included patients with recurrent UCS who had previously received chemotherapy and had HER2 immunohistochemistry scores ≥1+. The patients were categorized into the HER2-high group (immunohistochemistry score ≥2+; n = 22) and the HER2-low group (immunohistochemistry score of 1+; n = 10) for primary and exploratory analyses, respectively. Trastuzumab deruxtecan was administered intravenously every 3 weeks at doses of 6.4 or 5.4 mg/kg until unacceptable toxicity or disease progression. Dose modifications were made based on the recommended phase II dose for breast cancer (5.4 mg/kg). The primary endpoint was the objective response rate in the HER2-high group as assessed by central review. Secondary endpoints included overall response rate, progression-free survival, overall survival, and safety.

The objective response rate in the HER2-high group as assessed by the central review was 54.5% (95% CI, 32.2 to 75.6), and in the HER2-low group, it was 70.0% (95% CI, 34.8 to 93.3). The objective response rates as assessed by the investigator assessment were 68.2% and 60.0% in the HER2-high and HER2-low groups, respectively. The median progression-free survival was 6.2 months in the HER2-high group and 13.3 months in the HER2-low group. The median overall survival was 6.7 months in the HER2-high group and not reached in the HER2-low group. Grade ≥3 adverse events were observed in 61% of patients. Pneumonitis/interstitial lung disease of grades 1-2 occurred in 24% of patients, while grade 3 events occurred in 3% of patients.

Trastuzumab deruxtecan demonstrated efficacy in patients with UCS, regardless of their HER2 status. The safety profile was consistent with previous reports, and toxicities were manageable with appropriate monitoring and treatment.

Source: ascopubs.org/doi/full/10.1200/JCO.22.02558