• The filing is based on the results from an investigator-initiated Japanese phase II clinical study in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL)
• If approved, Tecentriq is expected to be the first immune checkpoint inhibitor in Japan for R/R ENKL, a disease with poor prognosis for which no standard treatment has been established.

TOKYO, October 31, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq^® Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL).

“ENKL is a rare type of malignant lymphoma 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.

This filing is based on the results from a phase II ATTACK study initiated by investigators in Japan including National Cancer Center Hospital, which evaluated the efficacy and safety of Tecentriq in patients with R/R ENKL. Response was shown in 7 out of 13 cases and the study met its primary endpoint with an overall response rate of 53.8% (95% CI: 25.1-80.8%). The safety profile was consistent with that in other tumors.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical need in cancer treatment with innovative medicines for patients and healthcare professionals.

About ATTACK study¹
ATTACK study (NCCH1903, jRCT2031190177) 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. 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.
ATTACK study is being conducted as a substudy of the MASTER KEY project, which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital.

About extranodal natural killer/T-cell lymphoma, nasal type (ENKL)
ENKL is a form of malignant lymphoma that primarily affects the nasal cavity. It can occur in individuals of all ages, from children to adults.^2,3,4 ENKL is rare, accounting for approximately 0.68% of all malignant lymphoma cases (annual incidence: about 36,000 cases) in Japan.⁵ For patients with advanced ENKL, about 60% experience relapse following initial treatment.^6,7 Relapsed or refractory ENKL has a poor prognosis, and there is currently no established standard treatment.

About Tecentriq⁸
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 4 indications (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma). Tecentriq was filed for additional indication of alveolar soft part sarcoma in March 2024.

Trademarks used or mentioned in this release are protected by law.

Sources

1. Makita S, et al. Phase 2 study of anti-PD-L1 antibody atezolizumab in patients with relapsed/refractory extranodal natural killer/T-cell lymphoma: NCCH1903/ATTACK study. European Hematology Association 2024 (Abstract: P1170)
2. Swerdlow SH, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues WHO Classification of Tumours, Revised 4th Edition. International Agency for Research on Cancer.
3. Makita S, et al. Clinical Features and Current Optimal Management of Natural Killer/T-Cell Lymphoma. Hematol Oncol Clin North Am. 2017;31(2):239-253
4. R Suzuki, et al. Prognostic factors for mature natural killer (NK) cell neoplasms: aggressive NK cell leukemia and extranodal NK cell lymphoma, nasal type. Ann Oncol. 2010;21(5):1032-40
5. Reiji M, et al. Epidemiology and secular trends of malignant lymphoma in Japan: Analysis of 9426 cases according to the World Health Organization classification. Cancer Med. 2018;7(11):5843-5858.
6. M. Yamaguchi, et al. Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer (NK)/T-cell lymphoma, nasal type: the NK-Cell Tumor Study Group study. J Clin Oncol, 29 (2011), pp. 4410-6.
7. Xin Li, et al. DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China. Clin Cancer Res. 2016 Nov 1;22(21):5223-5228.
8. Tecentriq for injection 840 mg/ 1200 mg. Electronic package insert. July 2024 (Version 7)