Daiichi Sankyo Company announced that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Delytact (teserpaturev/G47?), an oncolytic virus, for the treatment of patients with malignant glioma.
Delytact previously received SAKIGAKE Designation and Orphan Drug Designation from the MHLW for this indication and is now the first oncolytic virus to be approved in any region of the world for treatment of malignant glioma or any type of primary brain cancer. Daiichi Sankyo has been collaboratively developing Delytact with Dr. Tomoki Todo of the Institute of Medical Science, The University of Tokyo, and is the Marketing Authorization Holder of Delytact in Japan.
The approval of Delytact in Japan is based on results of a single-arm phase 2 clinical trial evaluating Delytact in patients with residual or recurrent glioblastoma, the most common and aggressive form of malignant glioma.1 The trial met its primary endpoint for one-year survival rate in an interim analysis. Results of the study will be submitted for publication by Dr. Todo.
“With the approval of Delytact in Japan we can now offer the first-ever oncolytic virustherapy option to patients with glioblastoma and other malignant gliomas that are not controlled with currently available treatments,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “Delytact is the fourth oncology medicine to be approved in Japan for Daiichi Sankyo over the past two years and we are grateful for the opportunity to collaborate with Dr. Todo to deliver this truly innovative treatment modality to patients and physiciansin Japan.”
Glioma, which originatesin glial cells in brain tissue, represents almost 80 percent of all malignant primary brain tumors. Glioma is classified from grade I to IV based on the level of malignancy.
The phase 2 open-label, single-arm, non-randomized, single-centerstudy conducted by Dr. Todo of the Institute of Medical Science, The University of Tokyo, evaluated the safety and efficacy of G47? (Delytact) in adult patients with glioblastoma who had been treated with radiotherapy and temozolomide chemotherapy and had one residual tumor or one recurrent lesion after the initial treatment.
The primary endpoint of the trial is one-year survival rate after initiation of Delytact therapy, analyzed using historical control. Secondary endpoints include progression-free survival, overall survival and overall response rate.
Delytact (teserpaturev/G47?) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) developed by Dr. Todo and his colleagues. Delytact has triple mutation within the viral genome that cause augmented and selective replication in cancer cells and enhanced induction of antitumor immune response while retaining high safety features. Delytact is currently the first third generation oncolytic HSV-1 to be evaluated in humans.
Delytact has received conditional and time-limited approval in Japan for the treatment of patients with malignant gliomas based on the phase 2 study results. Continued approval for this indication may be contingent upon verification and description of clinical benefit and safety in a post-market comparative clinical study. Delytact is not approved for any use outside of Japan.
