Nippon Shinyaku Co., Ltd.
Chugai Pharmaceutical Co., Ltd.

Filing of Humanized Anti-CD20 Monoclonal Antibody Gazyva
for Additional Indication of Chronic Lymphocytic Leukemia
Chugai files for regulatory approval following the results from the Phase III ELEVATE-TN
study evaluating Gazyva and acalabrutinib in patients with untreated CLL
TOKYO, March 7, 2022 -- Nippon Shinyaku Co., Ltd. (TOKYO: 4516) and Chugai
Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Chugai filed a regulatory application
with the Ministry of Health, Labour and Welfare (MHLW), for approval of an anti-cancer
agent/humanized anti-CD20 monoclonal antibody Gazyva® Intravenous Infusion 1000 mg[generic name; obinutuzumab (genetical recombination)] for the treatment of chronic lymphocytic
leukemia (CLL).
“We are very pleased that Gazyva was applied for marketing approval for a new indication in
CLL,” said Nippon Shinyaku's President, Toru Nakai. “We believe that the addition of the CLL
indication to Gazyva will help medical needs and further contribute to the treatment of patients inthe field of hematologic malignancies, which is one of our focus field.”“Ensuring safety during long-term treatment is increasingly important as the recent expansion intreatment options may lead to longer survival for patients with CLL. As a result, there is a growing
unmet medical need for treatments that control disease and have an acceptable safety profile,”
said Chugai’s President and CEO, Dr. Osamu Okuda. “We are working towards approval ofGazyva so the drug can contribute to treatment as a new therapeutic option for CLL.”
The filing is based on the results including Phase III ELEVATE-TN study (ACE-CL-007)
conducted by AstraZeneca, evaluating the efficacy and safety of Gazyva and acalabrutinib(Bruton's tyrosine kinase (BTK) inhibitor, brand name Calquence®) in patients with untreated
CLL.
About ELEVATE-TN study
ELEVATE-TN (ACE-CL-007, NCT02475681) study is a randomized, multicenter, open-label
Phase III trial evaluating the safety and efficacy of acalabrutinib in combination withobinutuzumab or alone versus chlorambucil (unapproved) in combination with obinutuzumab inpreviously untreated patients with CLL. In the study, patients are randomized 1:1:1 to following
groups;Chlorambucil plus obinutuzumabAcalabrutinib plus obinutuzumabAcalabrutinib monotherapy

The primary endpoint is IRC-assessed progression-free survival (PFS) with acalabrutinib plus
obinutuzumab versus chlorambucil plus obinutuzumab. Secondary endpoint is IRC-assessed
PFS with acalabrutinib monotherapy versus chlorambucil plus obinutuzumab. Other secondary
endpoints are objective response rate, time to next treatment and overall survival etc 1).
About Gazyva (obinutuzumab)
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, aprotein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed toattack and destroy targeted B cells both directly and together with the body's immune system.
Nippon Shinyaku and Chugai jointly develop and market the product in Japan.
About chronic lymphocytic leukemia (CLL)
Chronic lymphocytic leukemia (CLL) a rare type of lymphoma accounting for less than one casein 100,000 population annually 2). In CLL, blood stem cells in the bone marrow become
excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As
the number of abnormal cells grows there is less room for healthy white blood cells, red bloodcells, and platelets. This could result in anemia, infection, and bleeding 3). B-cell receptor
signaling through BTK is one of the essential growth pathways for CLL.
Trademarks used or mentioned in this release are protected by law.
[Reference]
1.

ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib(ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL.
https://clinicaltrials.gov/ct2/show/NCT02475681 [Internet. Accessed in January 2022]

2.

Center for Cancer Control and Information Services, National Cancer Center. Chronic
lymphocytic leukemia/small lymphocytic lymphoma
https://ganjoho.jp/public/cancer/CLL/index.html [Internet. Accessed in January 2022.
Japanese only]

3.

Takizawa J, et al. Comparative Analysis of Japanese and European Typical CLL Patients.
Blood. 02 December 2016;128(22):5564.

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Nippon Shinyaku Co., Ltd.

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