Journal article

Combined PIK3CA and FGFR inhibition with alpelisib and infigratinib in patients with PIK3CA-mutant solid tumors, with or without fgfr alterations

DM Hyman, B Tran, L Paz-Ares, JP MacHiels, JH Schellens, PL Bedard, M Campone, PA Cassier, J Sarantopoulos, U Vaishampayan, R Chugh, A Mahipal, AC Lockhart, C Sessa, T Zander, M Ng, G Curigliano, J Bendiske, X Chen, S Choudhury Show all

JCO Precision Oncology | Published : 2019

Abstract

PURPOSE Concurrent PIK3CA mutations and fibroblast growth factor receptor (FGFR) alterations occur in multiple cancer types, including estrogen receptor–positive breast cancer, bladder cancer, and endometrial cancer. In this first-in-human combination trial, we explored safety and preliminary efficacy of combining the PI3Kα selective inhibitor alpelisib with the FGFR1-4 selective inhibitor infigratinib. PATIENTS AND METHODS Patients with PIK3CA-mutant advanced solid tumors, with or without FGFR1-3 alterations, were enrolled in the dose escalation or one of three molecular-defined dose-expansion cohorts. The primary end point was the maximum tolerated dose. Secondary end points included safet..

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