22IN - Overview of Trials Testing Tumour Molecular Profiling

Abstract

ABSTRACT The feasibility to incorporate molecular screening approaches based on highthroughput technologies in cancer patients is now clearly established and is tested across prospective trials around the world. Such trials can be divided in 2 main groups: 1) First generation trials which are molecular triage trials without randomization and frequently without a build-in approach to gain access to the ad hoc molecular targeted therapies. 2) Second generation trials that encompass within the trial the access to targeted therapies, a randomization component and usually test the relevance of a new algorithm rather than the efficacy of a given compound and matched abnormality SAFIR01 is one of main prospective first-generation precision medicine trial ever conducted in breast cancer and demonstrated not only the feasibility of such an approach but also the high interest of patients and the potential associated benefit for patients with specific molecular alterations of FGFR/EGFR or PI3K pathway (Andre F et al. The Lancet Oncology 2014). The table herebelow provides a non-exhaustive list of some of the ongoing trials. Trial or program name and origin Genomics analysis technics Cancer types Clinical trial reference SHIVA Curie Institute, Paris, France IonTorrent/PGM (Amplicon sequencing) + CytoscanHD Solid tumors NCT01771458 MOSCATO Gustave Roussy, Villejuif, France IonTorrent/PGM* (Amplicons sequencing) CGHa (WG) Solid tumors eligible for Phase I trials NCT01566019 SAFIR02 Gustave Roussy, Villejuif, France IonTorrent/PGM (Amplicons sequencing) + CGHa (WG) Breast metastatic Cancer or lung cancer NCT02117167 IMPACT MD Anderson Cancer Center, Houston, US Targeted – HostSpot (PCR based and FISH) Solid tumors NCT00851032 IMPACT Princess Margaret Cancer Centre, Toronto, Canada Targeted - Host Spot (Sequanom) – MiSeq (sequence) Selected Solid Tumors NCT01505400 WINTHER WIN Consortium, Inernational Fondation On - CGHa - Whole Transcriptome Solid tumors NCT01856296 Battle-2 MD Anderson Cancer Center, Houston, US Targeted - Host spot (PCR-based and FISH) NSCLC, PD on chemotherapy NCT01248247 IMAGE Study Johns Hopkins, Baltimore, US NGS (Foundation One) Metastatic Breast Cancer NCT01939847 Disclosure: The author has declared no conflicts of interest.