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Ref Type abstract
PMID
Authors Elie G. Dib; Michael Rothe; Pam K. Mangat; Elizabeth Garrett-Mayer; Dustin Bivins; Mark Gitau; Apar K. Ganti; Arthur Winer; Vijay Suhag; Darryl Outlaw; Michael J. Hall; Olatunji B. Alese; Reza Nazemzadeh; Evan Pisick; Fengting Yan; Navid Hafez; Carmen J. Calfa; Lex Leonhardt; David DeRemer; Abigail Gregory; Dominique C. Hinshaw; Gina N. Grantham; Susan Halabi; Richard L. Schilsky
Title Abstract CT228: Talazoparib (Tala) in patients (pts) with solid tumors with ATM 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/CT228/761477/Abstract-CT228-Talazoparib-Tala-in-patients-pts`
Abstract Text 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 ATM mutation (mut) or deletion (del) treated with Tala are reported. Methods: Eligible pts had metastatic 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 1 mg of Tala orally daily until disease progression. Low accruing histology-specific cohorts with ATM alterations 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 at least 16+ weeks (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: 29 pts with nine different solid tumors with ATM mut (n=28) or del (n=1) were enrolled. 1 pt was not evaluable for efficacy. Table shows demographics, outcomes, and toxicity. 2 PR (lung and thyroid) and 10 SD16+ (pancreas [3], prostate [2], colon, breast, kidney, rectum, stomach, thyroid) were observed in pts with ATM mut for a DC rate of 41% (1-sided 90% CI, 29 to 100) and an OR rate of 7% (95% CI, 1 to 23). The null DC rate was rejected (p=0.0005). The pt with PR and lung cancer is still on tx and has exceeded 73 wks on study as of October 2024. 8 pts had ≥1 grade 3-4 tx-related adverse event (AE). No tx-related serious AE were reported. Conclusions: Tala met prespecified criteria to declare a signal of activity in pts with solid tumors with ATM mut.

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