10178- ACT-11 A PHASE 1 STUDY OF LOMUSTINE MONOTHERAPY AND COMBINATION THERAPY WITH PROCARBAZINE, LOMUSTINE, AND VINCRISTINE IN JAPANESE PATIENTS WITH GLIOMA (LOMG)

Abstract In the development of treatments for glioma, international clinical trials have demonstrated the efficacy of carmustine (BCNU), lomustine (CCNU), and methyl-CCNU against glioma. In Japan, nimustine (ACNU) has been developed and is used as a treatment for glioma. Internationally, compared to BCNU, the combination therapy of procarbazine, lomustine (CCNU), and vincristine (PCV therapy) has been confirmed to extend the survival period for glioma Grade 2/3, and numerous clinical trial results using PCV therapy have been accumulated. As a result, PCV therapy has become the standard treatment for Grade 2/3 oligodendroglioma and Grade 2 astrocytoma worldwide. However, lomustine is not approved in Japan, making it impossible to implement the standard treatment used overseas. Therefore, in 2019, the Japan Society for Neuro-Oncology submitted a request for the domestic development of lomustine to the ‘Meeting for the Evaluation of Unapproved Drugs and Indications with High Medical Needs.’ As a result of deliberation, it was determined in 2022 that clinical trial results involving Japanese subjects were necessary. Consequently, this physician-led trial was planned as a Phase I trial of lomustine, and the trial began in 2023. This report provides an overview and background of this clinical trial.