Tucatinib + subcutaneous (SC) trastuzumab (Tuc + Trast SC) in patients (pts) with solid tumors with ERBB2 alterations (alts): Results from the targeted agent and profiling utilization registry (TAPUR) study.

作者：Tareq Al Baghdadi, Michael Rothe, Elizabeth Garrett-Mayer, Funda Meric-Bernstam, Kathryn F. Mileham, Roozbeh Mohajer, Chukwuemeka Ikpeazu, Mehmet Akce, Andrew Gregory, Laura Tenner, Raymond Wadlow, Olatunji B. Alese, Stephanie Ann Dublis, David Gill, Jared D. Acoba, Abigail Gregory, Dominique C. Hinshaw, Gina N. Grantham, Susan Halabi, Richard L. Schilsky · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.3104 · 研究领域：HER2/EGFR in Cancer Research、Colorectal Cancer Treatments and Studies、Protease and Inhibitor Mechanisms

3104 Background: TAPUR is a phase II basket study evaluating the antitumor activity of commercially available targeted agents in pts with advanced cancers with specific genomic alts. Combined results of four cohorts of pts with solid tumors with ERBB2 alts treated with Tuc + Trast SC are reported. Methods: Eligible pts had measurable disease, ECOG performance status (PS) 0-2, adequate organ function, and no standard treatment (tx) options. Genomic testing was done in CLIA-certified, CAP-accredited labs. Dosing was 300 mg of Tuc given orally twice daily, 600 mg of Trast and 10,000 units of hyaluronidase SC every 3 weeks (wks), until disease progression. Primary endpoint was disease control (DC) per investigator definition as complete (CR) or partial (PR) response or stable disease (SD) of at least 16 wks duration (SD16+) per RECIST v.1.1. The hypothesized null DC rate of 15% was rejected if the lower limit of a 1-sided 90% CI was >15%. Inferences were based on a beta-binomial model, which accounts for tumor type variance. Secondary endpoints were progression-free survival (PFS), overall survival (OS), objective response (OR), duration of response, duration of SD (DOSD), and safety. Results: 78 pts (histology-pooled [n=40], lung [n=16], biliary tract [n=11], uterus [n=11]) with 21 tumor types with ERBB2 alts ( ERBB2 amplification [amp], n=38; mutation [mut], n=32; mut and amp, n=6; overexpression [OE], n=2) were enrolled. All cohorts were combined for analysis. 3 pts were no...