NOTES TO EDITORS
HIMALAYA is a randomized, open-label, multicenter, global Phase III trial of IMFINZI monotherapy and the combination of IMFINZI and tremelimumab vs. the standard-of-care medicine sorafenib, a multi-kinase inhibitor, in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy. The trial is being conducted in 189 centers across 16 countries including in the US, Canada, Europe, South America and Asia. The primary endpoint is overall survival and key secondary endpoints include objective response rate and progression-free survival.
About Hepatocellular carcinoma (HCC)
7072彩票代理Liver cancer is the third leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. HCC represents about 75% - 80% of all primary liver cancers. More than 800,000 people were diagnosed with HCC around the world in 2018, and an estimated 42,000 patients were diagnosed in the US last year. Between 80-90% of all patients with HCC also have chronic liver disease, which is primarily caused by infection with the hepatitis B or C viruses. Chronic liver disease is associated with inflammation that, over time, results in immunosuppression and can lead to the development of HCC. The unique immune environment of liver cancer provides clear rationale for researching medicines that harness the power of the immune system to treat HCC. A critical unmet need exists for patients with HCC who face limited treatment options. More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.
About IMFINZI? (durvalumab)
IMFINZI?7072彩票代理 (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
7072彩票代理IMFINZI is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 54 countries, including the US, Japan, China and across the EU, based on the Phase III PACIFIC trial. IMFINZI is also approved for previously treated patients with advanced bladder cancer in 15 countries, including the US.
IMFINZI is under Priority Review with FDA for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2020.
As part of a broad development program, IMFINZI is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumors.
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial program in combination with IMFINZI in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer.
About AstraZeneca Support Programs
7072彩票代理AstraZeneca strives to ensure that appropriate patients and their oncologists have access to IMFINZI and relevant support resources. These include educational resources, an Oncology Nurse Educator program and affordability and reimbursement programs, such as Access 360?.
Additionally, AstraZeneca has launched Lighthouse, a program that provides support to patients during any immune-mediated adverse events they may encounter during treatment, through medically trained Lighthouse Advocates. The program aims to make patients’ treatment experience as comfortable as possible. Find out more about Lighthouse at LighthouseProgram.com or call 1-855-LHOUSE1(1-855-546-8731).
About AstraZeneca’s Approach to Immuno-Oncology (IO)
7072彩票代理IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumor immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.
7072彩票代理We are pursuing a comprehensive clinical-trial program that includes IMFINZI (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumor types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with radiation, chemotherapy, small targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumors.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in hematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit gdlvh.com/7072彩票代理 and follow us on 7072彩票代理 @AstraZenecaUS.