SY10-4 - Comprehensive screening of target molecules by next-generation sequencing in patients with malignant tumors

Abstract

National Cancer Center have developed original next generation sequencing, NCC Oncopanel for comprehensive gene screening to realize precision medicine for cancer treatment. We have conducted the genome project to evaluate the clinical efficacy and feasibility for accelerating drug development and facilitating dug access. The project name is TOP GEAR, Trial of Onco Panel for Gene profiling to Estimate both Adverse events and Response by cancer treatment. First, we performed a prospective study to evaluate the feasibility of comprehensive gene screening for guiding entry into phase I clinical trials. Actionable alterations were identified in 45% of the analyzed patients. Common actionable alterations were found in PIK3CA mutation, BRCA2 mutation, ERBB2 amplification, and CCND1 amplification. In total, 22% of the analyzed patients could be entered into phase I clinical trials, and 8% of them were treated with matched drugs. Among patients who received matched therapies, response and disease control rates were 33% and 78%. Based on the findings, we have continued the TOP GEAR project, have experienced a large number of cases in a CLIA certified lab which assure quality of the NGS testing. We plan regulatory approval and Insurance reimbursement of the NGS panel as companion diagnoses kit within next year. We also conducted registry and NGS screening project for rare cancers for guiding entry into Basket style of clinical trial. Rare cancers are diagnosed as under the frequency 6 Per 1000000 people, for example, Sarcoma, Glioma, NEC, GIST, Melanoma, Endocrine tumor, Vaginal cancer etc. The project name is MASTER KEY. The purpose of the project is Central Diagnosis and Registry of Rare Cancer Tumors and Establishment of treatment. In this symposium, we are going to discuss the point at issues and challenges to overcome toward future genome medicine in Japan.