Reference Detail

Ref Type

Abstract

PMID

Authors

Carmen Calfa, Michael Rothe, Pam K. Mangat, Elizabeth Garrett-Mayer, Eugene Ahn, Keerthi Gogineni, Nitin Rohatgi, Monika L. Burness, Anu Gaba, Omid Hamid, Tareq Albaghdadi, Alison Conlin, Philip Gold, Jordi Rodon, Ramya Thota and Richard L. Schilsky

Title

Sunitinib (S) in patients (pts) with metastatic breast cancer (mBC) with FGFR1 mutations or amplifications: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Journal	Vol	Issue	Date	Pages	Journal Short Title
Cancer Resarch	81	13_Suppl	July 2021

URL

https://cancerres.aacrjournals.org/content/81/13_Supplement/CT173

Abstract Text

Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. S is an oral multi-kinase inhibitor that inhibits Fibroblast Growth Factor Receptor family members 1-4 (FGFR1-4) in biochemical and cellular assays and is FDA approved in several tumor types. Results in a cohort of mBC pts with FGFR1 mutations (mut) or amplifications (amp) treated with S are reported. Methods: Eligible pts had mBC, no standard treatment (tx) options, measurable disease, ECOG Performance Status (PS) 0-2, and adequate organ function. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received S 50 mg orally daily for four weeks followed by two weeks off, until tumor progression. Simon 2-stage design tested the null disease control (DC) - defined as partial (PR), complete response (CR) or stable disease at 16+ weeks (SD 16+) - rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have DC, 18 more pts are enrolled. If ≥7 of 28 pts have DC, the null DC rate is rejected. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: Thirty pts with mBC with FGFR1 mut (1 pt), amp (28 pts), or both (1 pt) were enrolled from Oct 2016 to June 2019. 3 were not evaluable and excluded from efficacy analyses. Demographics and outcomes are summarized in Table 1. Two partial responses (PR) and 5 SD16+ (FGFR1 amp only) were observed for DC and OR rates of 29% (95% CI: 13%, 42%) and 7% (95% CI: 1%, 24%), respectively, and the null DC rate of 15% was rejected (p=0.09). S related grade 3-5 TAEs (Table 1) were consistent with the product label for S except encephalopathy. Conclusions: Monotherapy S showed modest anti-tumor activity and clinically significant TAEs in heavily pre-treated pts with mBC with FGFR1 amplification.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR1 amp	breast cancer	predicted - sensitive	Sunitinib	Phase II	Actionable	In a Phase II trial, Sutent (sunitinib) treatment demonstrated antitumor activity in metastatic breast cancer patients with FGFR1 amplification (n = 28), FGFR1 mutation (n = 1), or both (n = 1), and led to an objective response rate of 7% (2/30, including 2 partial responses), stable disease greater than 16 weeks in 5 patients, and a disease control rate of 29% (Cancer Res 2021;81(13_Suppl):Abstract nr CT173).	detail...