Site Editor



ASCO 2023: Chemotherapy-Free Regimen for HER2-Positive Metastatic Biliary Tract Cancer

By: Julia Fiederlein Cipriano
Posted: Tuesday, June 6, 2023

Treatment with the HER2-directed tyrosine kinase inhibitor tucatinib plus the monoclonal antibody trastuzumab appeared to be safe and active in a cohort of patients with previously treated HER2-positive metastatic biliary tract cancer, according to Yoshiaki Nakamura, MD, PhD, of the National Cancer Center Hospital Japan East, Kashiwa, and colleagues. These findings from the phase II SGNTUC-019 basket trial, which were presented during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 4007), appear to support this combination as a future chemotherapy-free treatment option for this population with historically poor outcomes. Tucatinib has been approved in the United States in the treatment of HER2-positive metastatic breast and colorectal cancers.   

A total of 30 patients who experienced disease progression after receiving at least one line of systemic therapy for metastatic disease were administered tucatinib (300 mg orally twice a day) plus trastuzumab (8 mg/kg intravenously followed by 6 mg/kg every 3 weeks) in a 21-day cycle. Follow-up data were provided for a median of 8.3 months.

The confirmed objective response rate was 46.7%; this included 1 patient with a complete response and 13 patients with a partial response. The median durations of response and progression-free survival were 6.0 and 5.5 months, respectively. The disease control rate was 76.7%. At data cutoff, 43.3% of patients had died. The 12-month overall survival rate was 53.8%.

Pyrexia (43.3%) and diarrhea (40.0%) were the most frequently reported treatment-emergent adverse events. Treatment-emergent adverse events of grade 3 or higher were observed in 60.0% of patients; however, of this population, 20.0% and 6.7% experienced events related to tucatinib and trastuzumab, respectively. A total of 6.7% of patients discontinued treatment with tucatinib because of treatment-emergent adverse events, cholangitis, and liver disorder. No deaths related to treatment-emergent adverse events were reported.

Disclosure: For full disclosure information for the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.