Phase I/II Study of Osimertinib With Bevacizumab in EGFR-mutated, T790M-positive Patients With Progressed EGFR-TKIs: West Japan Oncology Group 8715L (WJOG8715L)
Hiroaki Akamatsu, Shunsuke Teraoka, Satoshi Morita, Nobuyuki Katakami, Motoko Tachihara, Haruko Daga, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Hiroaki Akamatsu, Shunsuke Teraoka, Satoshi Morita, Nobuyuki Katakami, Motoko Tachihara, Haruko Daga, Nobuyuki Yamamoto, Kazuhiko Nakagawa
Abstract
Osimertinib is a standard treatment for epidermal growth factor receptor (EGFR)-mutated, T790M-positive patients with progression during EGFR-tyrosine kinase inhibitor (TKI) therapy. Osimertinib, a third-generation EGFR-TKI, allows progression-free survival of around 10 months, but its toxicity is well-tolerated compared with other EGFR-TKIs. Preclinical and clinical evidence suggests that EGFR-TKI may work synergistically with vascular endothelial growth factor inhibitors. We therefore plan a phase I/II study to investigate this possibility. In phase I, the primary endpoint is assessment of the tolerability of osimertinib and bevacizumab in 6 patients. Phase II then explores the efficacy of combined treatment compared with osimertinib monotherapy with progression-free survival as the primary endpoint. Secondary endpoints are overall response rate, time to treatment failure, overall survival, and safety. Eighty patients will be enrolled in phase II.
Keywords: Bevacizumab; EGFR mutation; Osimertinib.
Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.
Source: PubMed