Abstract CT226: Sunitinib (S) in patients (pts) with solid tumors with <i>FGFR2</i> alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Abstract Background: TAPUR is a phase II basket study evaluating antitumor activity of commercially available targeted agents in pts with advanced cancers with specific genomic alterations. Results in a cohort of pts with solid tumors with FGFR2 alterations treated with S are reported. Methods: Eligible pts had solid tumors, measurable disease, ECOG performance status (PS) 0-2, adequate organ function, and no standard treatment (tx) options. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received S at 50 mg orally once daily for 4 weeks (wks) followed by 2 wks off, until disease progression. Low accruing histology-specific cohorts with FGFR2 alteration were collapsed into 1 histology-pooled cohort for analysis. Primary endpoint was disease control (DC) per investigator defined as complete or partial response (PR) or stable disease (SD) of 16+ wks duration (SD16+) per RECIST v1.1. The hypothesized null DC rate of 15% was evaluated by a 1-sided exact binomial test (alpha 0.10; 82% power). Secondary endpoints were progression-free survival (PFS), overall survival (OS), objective response (OR), duration of response (DOR) and SD, and safety. Results: 28 pts with ten different solid tumors with FGFR2 mutation (mut) (n=19), FGFR2 amplification (amp) (n=2), FGFR2 amp and mut (n=4), FGFR2 fusion (n=2), or FGFR2 fusion, mut, and amp (n=1) were enrolled. Table shows demographics, outcomes, and toxicity. 3 PR (lung [2], uterus [1]; FGFR2 mut [3]) and 8 SD16+ (lung [2], ovary [2], cholangiocarcinoma [1], gallbladder [1], osteosarcoma [1], uterus [1]; FGFR2 mut [6], fusion [1], or amp and mut [1]) were observed for a DC rate of 39% (1-sided 90% CI, 27 to 100) and an OR rate of 11% (95% CI, 2 to 28). The null DC rate was rejected (p=0.0015). 10 pts had ≥1 grade 3 tx-related adverse (AE) or serious AE. Conclusions: S met prespecified criteria to declare a signal of activity in pts with solid tumors with FGFR2 alterations. Citation Format: Gordan Srkalovic, Michael Rothe, Pam K. Mangat, Elizabeth Garrett-Mayer, Kathryn F. Mileham, Bamidele Adesunloye, Natalia Colocci, M. Dwight Chen, Funda Meric-Bernstam, Evan Pisick, Alissa S. Marr, Amin Benyounes, Olatunji B. Alese, Abigail Gregory, Dominique C. Hinshaw, Gina N. Grantham, Susan Halabi, Richard L. Schilsky. Sunitinib (S) in patients (pts) with solid tumors with FGFR2 alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT226.