Chugai Files Tecentriq for R/R Extranodal Natural Killer/T-Cell Lymphoma in Japan
核心洞察
Chugai Pharmaceutical has filed for approval of Tecentriq (atezolizumab) in Japan for relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (搜索) (R/R ENKL).
The application is based on positive results from a Japanese phase II clinical trial (ATTACK study) demonstrating a 53.8% overall response rate in R/R ENKL patients.
If approved, Tecentriq would be the first immune checkpoint inhibitor available in Japan for R/R ENKL, addressing a significant unmet need due to the poor prognosis and lack of standard treatment.
Chugai Pharmaceutical Co., Ltd. has announced the filing of a regulatory application in Japan for Tecentriq (atezolizumab) for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (搜索) (R/R ENKL). This submission to the Ministry of Health, Labour and Welfare seeks to provide a new therapeutic option for patients with this rare and aggressive lymphoma, where current treatment options are limited and prognosis is poor.
The application is supported by data from the ATTACK study (NCCH1903, jRCT2031190177), a phase II, investigator-initiated trial conducted in Japan. The study evaluated the efficacy and safety of Tecentriq in patients with R/R ENKL. Results showed that Tecentriq achieved an overall response rate (ORR) of 53.8% (95% CI: 25.1-80.8%) as assessed by an independent review committee (IRC). Specifically, 7 out of 13 patients exhibited a response to the treatment, meeting the study's primary endpoint. The safety profile of Tecentriq in this study was consistent with its established safety profile in other tumor types.
Unmet Need in R/R ENKL
Extranodal natural killer/T-cell lymphoma, nasal type (搜索) (ENKL) is a rare and aggressive form of non-Hodgkin lymphoma that primarily affects the nasal cavity. While it can occur across all age groups, advanced stages of ENKL often relapse after initial treatment in approximately 60% of patients. Relapsed or refractory ENKL carries a poor prognosis, and currently, there is no established standard treatment for these patients. In Japan, ENKL accounts for approximately 0.68% of all malignant lymphoma (搜索) cases.
Tecentriq Mechanism of Action
Tecentriq is a cancer immune checkpoint inhibitor that targets PD-L1 (搜索), a protein expressed on tumor cells and tumor-infiltrating immune cells. By blocking the interaction between PD-L1 and its receptors PD-1 and B7.1 on T cells, Tecentriq aims to restore T cell activity and enhance the immune response against cancer cells. Tecentriq is already approved in Japan for several indications, including extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma.
About the ATTACK Study
The ATTACK study is a Japanese Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital to evaluate the efficacy and safety of Tecentriq in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (搜索). The study enrolled 14 patients to investigate safety and efficacy. The primary endpoint is independent review committee (IRC)-assessed overall response rate. Key secondary endpoints include progression-free survival, overall survival, and safety.
"ENKL is a rare type of malignant lymphoma (搜索) that primarily develops in the nose. It is known to have a poor prognosis, with about 60% of patients in advanced stages relapsing after initial treatment, and there is no standard therapy for relapsed cases. We are working to obtain approval so that Tecentriq, a cancer immunotherapy that demonstrated favorable efficacy, can be delivered to patients as soon as possible as a new therapeutic option for ENKL," said Chugai’s President and CEO, Dr. Osamu Okuda.