AstraZeneca Launches CALQUENCE® (Acalabrutinib) in China for Relapsed or Refractory Mantle Cell Lymphoma

ForExtensive Adult Mantle Cell LymphomaProviding patients with new treatment options that offer better survival outcomes and good safety.^[1]

ShanghaiMay 29, 2023PR Newswire -- On May 27, AstraZeneca's innovative targeted therapy drug Kangkeqi^®(English trade name: CALQUENCE^®, Generic Name: Acalabrutinib Capsules) Officially Launched in China. As a new-generation highly selective Bruton's Tyrosine Kinase (BTK) inhibitor, Acalabrutinib received conditional approval from the China National Medical Products Administration in March 2023 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Professor Jun Ma, Director of the Harbin Institute of Hematology and Oncology and Chief Supervisor of the Chinese Society of Clinical Oncology (CSCO); Professor Zhixiang Shen, Lifetime Professor of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and former Chairman of the Chinese Medical Association's National Hematology Society; Professor Xiaojun Huang, Director of the National Clinical Research Center for Hematologic Diseases and Director of the Peking University Institute of Hematology; Professor Depei Wu, Deputy Director of the Jiangsu Institute of Hematology and current Chairman of the Chinese Medical Association’s Hematology Branch; Professor Jun Zhu, Party Secretary of Beijing Cancer Hospital and Chief Physician of the Lymphoma Internal Medicine Department; Professor Yu Hu, President of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Director of the Hematology Institute of Huazhong University of Science and Technology; Professor Chunyan Ji, Vice President of Qilu Hospital of Shandong University and Director of the Oncology Center; Professor Jianyong Li, Director of the Hematology Department at the First Affiliated Hospital of Nanjing Medical University and Standing Committee Member of the Chinese Medical Association’s Hematology Society; Professor Lugui Qiu, Director of the Lymphoma Diagnosis and Treatment Center at the Chinese Academy of Medical Sciences Blood Disease Hospital and Director of Tianjin Cord Blood Hematopoietic Stem Cell Bank; Professor Huiqiang Huang, Deputy Chief of the Department of Internal Medicine at Sun Yat-sen University Cancer Center and Chief Expert of the Lymphoma Center at Sun Yat-sen University Affiliated Tumor Hospital; Professor Jie Jin, Honorary Director of the Hematology Department at the First Affiliated Hospital of Zhejiang University School of Medicine and Director of the Zhejiang Provincial Clinical Research Center for Hematological Diseases—along with nearly 50 authoritative experts in the field of hematology and oncology from China and abroad—as well as over 300 researchers and clinicians attending offline and more than 5,000 online participants, joined this launch event. Together, they witnessed Acalabrutinib opening a new chapter in the treatment of hematologic malignancies in China and demonstrated firm confidence in achieving the new goal of helping patients "live longer and live better."

BTK InhibitorHelping Patients "Live Longer, Live Better" Opening a New Era in Hematologic Oncology Treatment

MCL is a rare type of non-Hodgkin lymphoma (NHL), accounting for 2-6% of all NHL cases in China.^[2]The median age of diagnosed patients is usually between 60 and 70 years old, and the disease is often already at an advanced stage at the time of diagnosis.^[2]MCL has the characteristics of both indolent and aggressive lymphomas, but overall it is more aggressive with significant heterogeneity. According to different classifications, only 10-15% of patients present with indolent behavior.^[3]MCL remains an incurable disease with a median overall survival of approximately 69.6 months.^[4], only 8% survive more than 10 years.^[5], the 5-year survival rate of conventional chemotherapy is < 30%^[6]。

Professor Jun Zhu, Party Secretary of Peking University Cancer Hospital and Chief Physician of the Lymphoma Medical Oncology DepartmentIndicates:"Since the majority of patients with mantle cell lymphoma are elderly and cannot tolerate the toxicity of traditional chemotherapy, and despite their sensitivity to initial treatment, the relapse rate is very high, BTK inhibitors have become the preferred option for second-line and subsequent treatment of mantle cell lymphoma."^[7]The new generation BTK inhibitor, acalabrutinib, offers high target selectivity, fewer side effects, and a high remission rate compared to existing treatment options, providing better benefits for patients. This is especially good news for Chinese patients with mantle cell lymphoma, offering new hope for their high-quality, long-term survival.

Thirty Years of Progress: A Promising Future for Patients with Mantle Cell Lymphoma

Since entering China in 1993, AstraZeneca has been moving forward ceaselessly for 30 years, always patient-centered. It has made substantial progress and maintained consistent efforts in the oncology field. Several self-developed cancer drugs have brought significant benefits to Chinese cancer patients.

The newly launched acalabrutinib is the first hematological tumor treatment drug approved by AstraZeneca in China, marking AstraZeneca's official entry into the field of hematological tumor treatment in China. Long-term follow-up results from global studies show that in the treatment of MCL patients who have previously received at least one therapy, acalabrutinib demonstrated a median overall survival (OS) of up to 59.2 months, with a lower risk of adverse events related to off-target effects and overall good safety.^[8]。

Leo Wang, Executive Vice President of AstraZeneca PLC and President of International Business & China, stated:"This year marks the 30th anniversary of AstraZeneca's entry into China. As a cornerstone of AstraZeneca in the field of hematology and oncology, the successful launch of acalabrutinib in China is of milestone significance, demonstrating AstraZeneca's commitment to providing innovative and high-quality medicines to Chinese patients. In the future, we will continue to deepen our expertise in the treatment of hematological tumors, introduce globally innovative drugs, engage in extensive collaborative innovation, and strive to promote various market access initiatives and charitable assistance programs. We aim to support the standardization of hematology and oncology diagnosis and treatment, safeguard more patients with hematological tumors, and help more patients achieve 'a hopeful future for health'."

About Acalabrutinib

Acalabrutinib is a new generation of BTK selective inhibitor that inhibits its activity by covalently binding to BTK.^[9]In B cells, BTK signaling leads to the activation of pathways required for B cell proliferation, trafficking, chemotaxis, and adhesion.

Acalabrutinib has been approved in the United States for the treatment of relapsed or refractory MCL and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), in the European Union and many other countries worldwide for the treatment of CLL, and in Japan for the treatment of previously untreated as well as relapsed or refractory CLL/SLL.

As part of an extensive clinical development program, AstraZeneca and Acerta Pharma are currently evaluating acalabrutinib in more than 20 company-sponsored clinical trials for the treatment of various B-cell hematologic malignancies, including CLL, MCL, diffuse large B-cell lymphoma, Waldenström's macroglobulinemia, follicular lymphoma, and marginal zone lymphoma.

Research on AstraZeneca in the Field of Hematology

AstraZeneca is driving the scientific community to redefine the treatment of blood disorders. Through the acquisition of Alexion, we have expanded our commitment to patients with blood diseases, not only in oncology but also in the field of rare diseases, reaching those with highly unmet needs. Building on our deep understanding of hematological malignancies, leveraging our strengths in solid tumors, and utilizing Alexion's groundbreaking complement science technology to provide transformative medicines for rare diseases, we are pursuing the continuous development of novel therapies that directly target the underlying drivers of disease.

Patients with blood diseases have significant unmet treatment needs. We focus on this group, providing them with innovative drugs and therapies to improve outcomes. Through insights from patients, caregivers, and doctors, our goal is to transform the lives of those suffering from malignant, rare, and other related blood disorders, making the most meaningful impact.

About AstraZeneca's Research in the Oncology Field

AstraZeneca is leading a revolution in the field of oncology, committed to providing diversified cancer treatment solutions. Through scientific exploration of the complexities within the oncology field, AstraZeneca discovers, develops, and delivers life-changing drugs to patients. AstraZeneca’s oncology business focuses on the most challenging types of cancer. With continuous innovation, AstraZeneca has built a leading, diversified portfolio and pipeline across the industry, consistently driving changes in medical practice and transforming the patient experience.

AstraZeneca aims to redefine cancer treatment and conquer cancer in the future.

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-led global biopharmaceutical company focused on the research, development, production, and marketing of prescription medicines. Key areas of focus include oncology, biopharmaceuticals encompassing cardiovascular, renal, and metabolic diseases, respiratory and immunology, vaccines and infectious diseases, as well as rare diseases. AstraZeneca’s global headquarters is located in Cambridge, UK, with operations in over 100 countries worldwide, delivering innovative medicines to millions of patients globally. For more information, please visitwww.astrazeneca.com。

About AstraZeneca China

Since entering China in 1993, AstraZeneca has adhered to the principle of science first, focusing on innovation to meet the growing health needs of China and achieve its grand vision of "pioneering innovation for the benefit of patients and becoming China's most trusted healthcare partner." The headquarters of AstraZeneca in China is located in Shanghai, with regional headquarters established in Beijing, Guangzhou, Wuxi, Hangzhou, and Chengdu. The company has production bases in Wuxi and Taizhou, Jiangsu Province, and a logistics center in Wuxi. In China, AstraZeneca focuses primarily on treatment areas where Chinese patients have the most urgent needs, including oncology, cardiovascular, metabolic, renal, respiratory, gastroenterology, vaccines and antibodies, autoimmune diseases, and rare diseases. In 2017, the China Health IoT Innovation Center was established in Wuxi to explore innovative integrated solutions for full-course disease management using the Internet of Things. In the same year, AstraZeneca formed Dizal (Jiangsu) Pharmaceutical Co., Ltd. as a joint venture with SDIC Innovation to accelerate local new drug development. In 2019, AstraZeneca announced its collaboration with Wuxi to build the Wuxi International Life Science Innovation Park, harnessing global wisdom for the benefit of Chinese patients. In 2020, AstraZeneca announced support for the "Internet Hospital" project. In 2021, AstraZeneca officially upgraded its Global R&D China Center in Shanghai and, together with CICC Capital, initiated the AstraZeneca CICC Healthcare Industry Fund.

References:

^[1]. Wang M, et al. Blood (2020) 136 (Supplement 1): 38–39.
^[2].  Yoon DH, et al. Treatment of mantle cell lymphoma in Asia: a consensus paper from the Asian Lymphoma Study Group. Journal of Hematology & Oncology. 2020; 13(21)Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med. 2020; 54(1): 34-44.
^[3].Journal of Clinical Hematology 2016, v.29; No.201(03) 424-427.
^[4].  Martin P, et al. J Clin Oncol 2022;41(3):541-554.
^[5].  AmJ Hematol. 2017 Aug;92(8):806-813.
^[6].  McKay,P., Leach, M., et al. (2012). Br J Haematol. 159(4): 405-26.
^[7].  Dreyling M, et al. Leuk Lymphoma. 2018 Aug;59(8):1814-1828.
^[8].  Michael Wang, MD et al. Blood (2020) 136 (Supplement 1): 38–39.
^[9].  Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21)

Statement
The use of certain investigational drugs has not yet been approved for indications in China, and AstraZeneca does not recommend the use of any unapproved drugs.