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New Indication: Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer

New Indication: Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer
Study:
  • Phase II, basket study (SGNTUC-019)
  • Previously treated with and progressed after ≥1 line of systemic therapy for HER2-positive metastatic disease.
  • Tucatinib (TUC) 300 mg orally twice a day + Trastuzumab (Tras) q21 (n=30)
Efficacy:
  • cORR: 46.7% [14 of 30 pts]
  • CR: 0.03% [1 of 30 pts]
  • mDOR: 6.0 mos [5.5-NR]
  • mPFS: 5.5 mos [3.9-8.1]
  • 12-month OS: 53.8% [35.2-69.1]
Safety:
  • Any Grade: pyrexia (43.3%) and diarrhea (40.0%)
  • Two (6.7%) pts discontinued TUC due to TEAEs, cholangitis and liver disorder.

Journal of Clin Oncol 2023 41:16_suppl, 4007-4007

Nakamura Y et al. Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study.

http://doi.org/10.1200/JCO.2023.41.16_suppl.4007

Reviewed by Elvin CHALABİYEV, MD on JUN 10, 2023

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