TY - JOUR
T1 - Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019)
T2 - A Phase II Basket Study
AU - Nakamura, Yoshiaki
AU - Mizuno, Nobumasa
AU - Sunakawa, Yu
AU - Canon, Jean Luc
AU - Galsky, Matthew D.
AU - Hamilton, Erika
AU - Hayashi, Hidetoshi
AU - Jerusalem, Guy
AU - Kim, Seung Tae
AU - Lee, Keun Wook
AU - Kankeu Fonkoua, Lionel Aurelien
AU - Monk, Bradley J.
AU - Nguyen, Danny
AU - Oh, Do Youn
AU - Okines, Alicia
AU - O'Malley, David M.
AU - Pohlmann, Paula
AU - Reck, Martin
AU - Shin, Sang Joon
AU - Sudo, Kazuki
AU - Takahashi, Shunji
AU - Van Marcke, Cedric
AU - Yu, Evan Y.
AU - Groisberg, Roman
AU - Ramos, Jorge
AU - Tan, Sherry
AU - Stinchcombe, Thomas E.
AU - Bekaii-Saab, Tanios
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/12/20
Y1 - 2023/12/20
N2 - PURPOSETo evaluate the efficacy and safety of tucatinib and trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) metastatic biliary tract cancer (mBTC).METHODSSGNTUC-019 (ClinicalTrials.gov identifier: NCT04579380) is an open-label phase II basket study evaluating the efficacy and safety of tucatinib and trastuzumab in patients with HER2-altered solid tumors. In the biliary tract cancer cohort, patients had previously treated HER2 overexpressing or amplified (HER2+) tumors (identified with local testing) with no prior HER2-directed therapy. The primary end point was confirmed objective response rate (cORR) per investigator assessment. Patients were treated on a 21-day cycle with tucatinib (300 mg orally twice daily) and trastuzumab (8 mg/kg intravenously followed by 6 mg/kg every 3 weeks).RESULTSThirty patients were enrolled. As of data cutoff (January 30, 2023), the median duration of follow-up was 10.8 months. The cORR was 46.7% (90% CI, 30.8 to 63.0), with a disease control rate of 76.7% (90% CI, 60.6 to 88.5). The median duration of response and progression-free survival were 6.0 months (90% CI, 5.5 to 6.9) and 5.5 months (90% CI, 3.9 to 8.1), respectively. At data cutoff, 15 patients (50.0%) had died, and the estimated 12-month overall survival rate was 53.6% (90% CI, 36.8 to 67.8). The two most common treatment-emergent adverse events (TEAEs) were pyrexia (43.3%) and diarrhea (40.0%). Grade ≥3 TEAEs were reported in 18 patients (60.0%), with the most common being cholangitis, decreased appetite, and nausea (all 10.0%), which were generally not treatment related. TEAEs led to treatment regimen discontinuation in one patient, and there were no deaths due to TEAEs.CONCLUSIONTucatinib combined with trastuzumab had clinically significant antitumor activity and was well tolerated in patients with previously treated HER2+ mBTC.
AB - PURPOSETo evaluate the efficacy and safety of tucatinib and trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) metastatic biliary tract cancer (mBTC).METHODSSGNTUC-019 (ClinicalTrials.gov identifier: NCT04579380) is an open-label phase II basket study evaluating the efficacy and safety of tucatinib and trastuzumab in patients with HER2-altered solid tumors. In the biliary tract cancer cohort, patients had previously treated HER2 overexpressing or amplified (HER2+) tumors (identified with local testing) with no prior HER2-directed therapy. The primary end point was confirmed objective response rate (cORR) per investigator assessment. Patients were treated on a 21-day cycle with tucatinib (300 mg orally twice daily) and trastuzumab (8 mg/kg intravenously followed by 6 mg/kg every 3 weeks).RESULTSThirty patients were enrolled. As of data cutoff (January 30, 2023), the median duration of follow-up was 10.8 months. The cORR was 46.7% (90% CI, 30.8 to 63.0), with a disease control rate of 76.7% (90% CI, 60.6 to 88.5). The median duration of response and progression-free survival were 6.0 months (90% CI, 5.5 to 6.9) and 5.5 months (90% CI, 3.9 to 8.1), respectively. At data cutoff, 15 patients (50.0%) had died, and the estimated 12-month overall survival rate was 53.6% (90% CI, 36.8 to 67.8). The two most common treatment-emergent adverse events (TEAEs) were pyrexia (43.3%) and diarrhea (40.0%). Grade ≥3 TEAEs were reported in 18 patients (60.0%), with the most common being cholangitis, decreased appetite, and nausea (all 10.0%), which were generally not treatment related. TEAEs led to treatment regimen discontinuation in one patient, and there were no deaths due to TEAEs.CONCLUSIONTucatinib combined with trastuzumab had clinically significant antitumor activity and was well tolerated in patients with previously treated HER2+ mBTC.
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U2 - 10.1200/JCO.23.00606
DO - 10.1200/JCO.23.00606
M3 - Article
C2 - 37751561
AN - SCOPUS:85180010578
SN - 0732-183X
VL - 41
SP - 5569
EP - 5578
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 36
ER -