R29 - ONCO-T-PROFIL: treatment of patients with refractory metastatic solid tumors according to a molecular characterization of potential predictive biomarkers

Abstract

Introduction: Patients with refractory metastatic cancer have been shown to benefit from molecular profiling of tumor tissue. The “ONCO-T-PROFIL” project was launched in March 2014 at the Department for Haematology and Oncology of Innsbruck Medical University. Within 2 years our project aims to recruit 100 patients with stage IV cancer. Our data presented here is based on an interims-analysis. Methods: Formalin-fixed tumor tissue specimens are submitted for molecular profiling to a certified laboratory in the USA (CARIS Life Intelligence©). Profiling methods used to identify and characterize potential predictive biomarkers include IHC, NGS and CISH/FISH. Druggable tumor targets and corresponding drug candidates were selected based on an evidence-based information system that associates the biomarker status to agents with potential clinical benefit or potential lack of benefit. Clinical benefit was defined as a PFS ratio (=PFS upon the last therapy/PFS upon treatment according to the molecular profile) ≥ 1.3. Results: Until April 2015, tumors from 50 patients have been molecularly profiled and in 48 (94%) one or more druggable target structures were detectable. So far, 19 (38%) patients have been treated or are currently undergoing treatment according to their molecular tumor profile. To date, 7 of 19 (36%) patients have benefitted by reaching a PFS ratio of ≥ 1.3. Conclusions: Up to now a subset of our patients showed a clinical benefit from a therapeutic regimen based on molecular typing. Our data demonstrate that a subgroup of patients can benefit from an individualized treatment approach based on molecular profiling.