[Current Status and Challenges in Tumor Agnostic Treatment]

Development of tumor agnostic treatment based on specific biomarkers has been quite active in recent years. In Japan, pembrolizumab for microsatellite instability high(MSI-high), entrectinib and larotrectinib for NTRK fusion gene and pembrolizumab for tumor mutation burden high(TMB-high)have been approved. In addition to these approvals, dostarlimab for mismatch repair deficiency(dMMR), dabrafenib and trametinib for BRAF V600E, and selpercatinib for RET fusion gene have been approved in the United States as tumor agnostic biomarkers and their treatment. Development of tumor agnostic treatment requires efficient implementation of clinical trials to target rare subtypes. Various efforts are underway to conduct such clinical trials, including the use of appropriate registries and the implementation of decentralized clinical trial. Another approach is to evaluate a number of combination regimens in parallel, as in the trials of KRAS G12C inhibitor, with the aim of improvement of efficacy or overcoming assumed resistant.