Clovis Oncology (NASDAQ:CLVS) today announced results from an ongoing Phase 1/2a monotherapy study evaluating lucitanib, the Company's novel, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFRα-β). Data from the study were presented today in an oral presentation by Professor Jean-Charles Soria at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
"Treatment with lucitanib in this Phase 1/2 clinical trial provided durable objective RECIST responses in patients with solid tumors. Specifically, patients with advanced breast cancer with FGF receptor or FGF ligand alterations experienced a 50% objective response rate and progression free survival of 9.6 months," said Professor Carlos L. Arteaga, MD, Associate Director for Clinical Research, Director of the Center for Cancer Targeted Therapies, and Director of the Breast Cancer Program at the Vanderbilt-Ingram Cancer Center of Vanderbilt University. "Although results to date from this ongoing clinical trial are early, they are still encouraging as they suggest that determination of genetic alterations in the FGF pathway could be important for identifying cancer patients most likely to benefit from treatment with lucitanib."
"We are extremely encouraged with the 50 percent response rate observed with lucitanib therapy in heavily pre-treated FGF-aberrant patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "These results support the further exploration of lucitanib in tumor types with FGFR pathway activation, and our Phase 2 program in breast cancer and squamous non-small cell lung cancer commences enrollment shortly. In parallel, two breast cancer trials are underway in Europe, sponsored by our development partner Servier."
Lucitanib is a potent inhibitor of fibroblast growth factor receptor 1-3 (FGFR1-3), vascular endothelial growth factor receptors 1-3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFRα-β). The FGF, VEGF and PDGF cellular signaling pathways each play a role in tumor growth and angiogenesis. FGF-related genetic changes, in particular, have been described in several cancer types, including breast and squamous non-small cell lung cancer, particularly in the context of acquired resistance to initial therapies.
Over 100 patients have been treated with lucitanib in this ongoing Phase 1/2a study. All patients treated in the dose-expansion cohorts have been identified as having FGF-aberrant or angiogenesis-sensitive solid tumors. Patients in the Phase 1 dose escalation portion of the study were treated with once-daily (QD) dosing of 5mg, 10mg, 20 mg or 30mg of lucitanib, data from which led to a recommended continuous dose of 10 to 20mg QD for the cohort-expansion phase of the study.