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Ref Type abstract
PMID
Authors 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
Title Abstract CT226: Sunitinib (S) in patients (pts) with solid tumors with FGFR2 alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Journal Vol Issue Date Pages Journal Short Title
Cancer Research 85 8_Supplement_2 April 15, 2025
URL https://aacrjournals.org/cancerres/article/85/8_Supplement_2/CT226/761479/Abstract-CT226-Sunitinib-S-in-patients-pts-with
Abstract Text 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.

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