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2025-07-29 08:00 Kvartalsrapport 2025-Q2
2025-04-29 - Kvartalsrapport 2025-Q1
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2025-02-20 - X-dag halvårsutdelning AZN 167.999995
2025-02-06 - Bokslutskommuniké 2024
2024-11-12 - Kvartalsrapport 2024-Q3
2024-08-08 - X-dag halvårsutdelning AZN 77.600002
2024-07-25 - Kvartalsrapport 2024-Q2
2024-04-25 - Kvartalsrapport 2024-Q1
2024-04-11 - Årsstämma
2024-02-22 - X-dag halvårsutdelning AZN 155.999994
2024-02-08 - Bokslutskommuniké 2023
2023-11-09 - Kvartalsrapport 2023-Q3
2023-08-10 - X-dag halvårsutdelning AZN 71.799999
2023-07-28 - Kvartalsrapport 2023-Q2
2023-04-27 - Årsstämma
2023-04-27 - Kvartalsrapport 2023-Q1
2023-02-23 - X-dag halvårsutdelning AZN 162.800002
2023-02-09 - Bokslutskommuniké 2022
2022-11-10 - Kvartalsrapport 2022-Q3
2022-08-11 - X-dag halvårsutdelning AZN 76.4
2022-07-29 - Kvartalsrapport 2022-Q2
2022-04-29 - Årsstämma
2022-04-29 - Kvartalsrapport 2022-Q1
2022-02-24 - X-dag halvårsutdelning AZN 145.299995
2022-02-10 - Bokslutskommuniké 2021
2021-11-12 - Kvartalsrapport 2021-Q3
2021-08-12 - X-dag halvårsutdelning AZN 64.8
2021-07-29 - Kvartalsrapport 2021-Q2
2021-05-11 - Årsstämma
2021-04-30 - Kvartalsrapport 2021-Q1
2021-02-25 - X-dag halvårsutdelning AZN 137.399995
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2020-11-05 - Kvartalsrapport 2020-Q3
2020-08-13 - X-dag halvårsutdelning AZN 69.599998
2020-07-30 - Kvartalsrapport 2020-Q2
2020-04-29 - Årsstämma
2020-04-29 - Kvartalsrapport 2020-Q1
2020-02-27 - X-dag halvårsutdelning AZN 146.399999
2020-02-14 - Bokslutskommuniké 2019
2019-10-24 - Kvartalsrapport 2019-Q3
2019-08-08 - X-dag halvårsutdelning AZN 71.899998
2019-07-25 - Kvartalsrapport 2019-Q2
2019-04-26 - Årsstämma
2019-04-26 - Kvartalsrapport 2019-Q1
2019-02-28 - X-dag halvårsutdelning AZN 146.800005
2019-02-14 - Bokslutskommuniké 2018
2018-11-08 - Kvartalsrapport 2018-Q3
2018-08-09 - X-dag halvårsutdelning AZN 68.400002
2018-07-26 - Kvartalsrapport 2018-Q2
2018-05-18 - Årsstämma
2018-05-18 - Kvartalsrapport 2018-Q1
2018-02-15 - X-dag halvårsutdelning AZN 133.599997
2018-02-02 - Bokslutskommuniké 2017
2017-11-09 - Kvartalsrapport 2017-Q3
2017-08-10 - X-dag halvårsutdelning AZN 68.900001
2017-07-27 - Kvartalsrapport 2017-Q2
2017-04-27 - Årsstämma
2017-04-27 - Kvartalsrapport 2017-Q1
2017-02-16 - X-dag halvårsutdelning AZN 150.199997
2017-02-02 - Bokslutskommuniké 2016
2016-11-10 - Kvartalsrapport 2016-Q3
2016-08-11 - X-dag halvårsutdelning AZN 68.699998
2016-07-28 - Kvartalsrapport 2016-Q2
2016-04-29 - Årsstämma
2016-04-29 - Kvartalsrapport 2016-Q1
2016-02-18 - X-dag halvårsutdelning AZN 145.555556
2016-02-04 - Bokslutskommuniké 2015
2015-11-05 - Kvartalsrapport 2015-Q3
2015-08-13 - X-dag halvårsutdelning AZN 63.88889
2015-07-30 - Kvartalsrapport 2015-Q2
2015-04-24 - Årsstämma
2015-04-24 - Kvartalsrapport 2015-Q1
2015-02-19 - X-dag halvårsutdelning AZN 138.888896
2015-02-05 - Bokslutskommuniké 2014
2014-11-06 - Kvartalsrapport 2014-Q3
2014-08-13 - X-dag halvårsutdelning AZN 59
2014-07-31 - Kvartalsrapport 2014-Q2
2014-04-24 - Årsstämma
2014-04-24 - Kvartalsrapport 2014-Q1
2014-02-19 - X-dag halvårsutdelning AZN 129.777777
2014-02-06 - Bokslutskommuniké 2013
2013-10-31 - Kvartalsrapport 2013-Q3
2013-08-14 - X-dag halvårsutdelning AZN 65.777779
2013-08-01 - Analytiker möte 2013
2013-08-01 - Kvartalsrapport 2013-Q2
2013-04-25 - Årsstämma
2013-04-25 - Kvartalsrapport 2013-Q1
2013-02-13 - X-dag halvårsutdelning AZN 133.888888
2013-01-31 - Bokslutskommuniké 2012
2012-10-25 - Analytiker möte 2012
2012-10-25 - Kvartalsrapport 2012-Q3
2012-08-08 - X-dag halvårsutdelning AZN 64.555556
2012-07-26 - Kvartalsrapport 2012-Q2
2012-04-26 - Årsstämma
2012-04-26 - Kvartalsrapport 2012-Q1
2012-02-15 - X-dag halvårsutdelning AZN 137.333333
2012-02-02 - Bokslutskommuniké 2011
2011-10-27 - Kvartalsrapport 2011-Q3
2011-08-03 - X-dag halvårsutdelning AZN 57.666665
2011-07-28 - Kvartalsrapport 2011-Q2
2011-04-28 - Årsstämma
2011-04-28 - Kvartalsrapport 2011-Q1
2011-02-02 - X-dag halvårsutdelning AZN 129.666662
2011-01-27 - Bokslutskommuniké 2010
2010-10-28 - Kvartalsrapport 2010-Q3
2010-08-04 - X-dag halvårsutdelning AZN 49.888888
2010-07-29 - Kvartalsrapport 2010-Q2
2010-04-29 - Kvartalsrapport 2010-Q1
2010-02-03 - X-dag halvårsutdelning AZN 117.111111
2010-01-28 - Bokslutskommuniké 2009
2009-10-29 - Kvartalsrapport 2009-Q3
2009-08-05 - X-dag halvårsutdelning AZN 40
2009-07-30 - Kvartalsrapport 2009-Q2
2009-04-30 - Årsstämma
2009-04-30 - Kvartalsrapport 2009-Q1
2009-02-04 - X-dag halvårsutdelning AZN 116.444444
2008-08-06 - X-dag halvårsutdelning AZN 30.888888
2008-02-06 - X-dag halvårsutdelning AZN 75.2222222
2007-08-08 - X-dag halvårsutdelning AZN 28.111111
2007-02-07 - X-dag halvårsutdelning AZN 70
2006-08-09 - X-dag halvårsutdelning AZN 32.562658

Beskrivning

LandStorbritannien
ListaFTSE 100
SektorHälsovård
IndustriLäkemedel & Handel
AstraZeneca är ett globalt läkemedelsbolag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom terapiområdena som berör andningsvägar, hjärta/kärl/metabolism och cancer. Utöver huvudverksamheten är bolaget även aktiva inom autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt inom samtliga globala regioner och har sitt huvudkontor i Cambridge, Storbritannien.
2023-11-14 08:02:45

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient cohort which showed a 22% reduction in the risk of death versus chemotherapy alone.

AstraZeneca's Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin).

The approval by China's National Medical Products Administration (NMPA) was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence (https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200015), as well as a prespecified exploratory analysis (https://oncologypro.esmo.org/meeting-resources/esmo-congress/efficacy-and-safety-of-durvalumab-plus-gemcitabine-and-cisplatin-in-chinese-participants-with-advanced-biliary-tract-cancer-extension-cohort-of-th) of an additional cohort of patients in China.

BTC is a group of rare and aggressive cancers that occur in the bile ducts (cholangiocarcinoma) and gallbladder.[1,2] An estimated 211,000 new patients are diagnosed with gallbladder and biliary tract cancer each year, and nearly one in five patients diagnosed is in China.[3,4 ]These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.[5]

Shukui Qin, MD, President of Nanjing Tianyinshan Hospital of China Pharmaceutical University and national leading principal investigator of the trial in China, said: "Over the past decade, there has been little progress in the treatment of advanced biliary tract cancer. However, the successful results of the TOPAZ-1 trial confirmed that durvalumab plus routine chemotherapy has statistically significant and clinically meaningful overall survival and progression-free survival benefits for these patients. This approval provides a new and better option for the treatment of these patients in China."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "With this approval for Imfinzi plus chemotherapy, physicians will now be able to offer this global standard-of-care treatment to patients in China, where nearly one in five patients with biliary tract cancer is diagnosed. This important milestone underscores our commitment to bring innovative medicines that transform survival outcomes to people across the globe living with aggressive gastrointestinal tumours such as biliary tract cancer."

In an interim analysis of the TOPAZ-1 Phase III trial, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021). Median OS was 12.8 months versus 11.5 for chemotherapy. Additionally, efficacy results from a prespecified exploratory analysis in an additional cohort of TOPAZ-1 patients enrolled in China were consistent with those in the overall global trial population, showing Imfinzi plus chemotherapy reduced the risk of death by 22% versus chemotherapy alone (HR of 0.78; 95% CI, 0.51-1.18).

In the TOPAZ-1 trial, Imfinzi plus chemotherapy was generally well tolerated, with no new safety signals observed. Safety results in the cohort of Chinese patients were consistent with results in the overall global trial population.

Imfinzi plus chemotherapy is approved in the US (https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-approved-in-us-for-biliary-tract-cancer.html#!), EU (https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-approved-in-eu-for-biliary-tract-cancer.html) (1st-line), Japan (https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-imjudo-approved-in-japan-for-3-cancers.html) and other countries for the treatment of adults with locally advanced or metastatic BTC. Regulatory applications are also currently under review in several other countries based on the TOPAZ-1 results.

Notes

Biliary tract cancer
BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).[1,2]

Early-stage BTC affecting the bile ducts and gallbladder often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.[5-7 ]Cholangiocarcinoma is more common in China and Southeast Asia and is on the rise in Western countries.[1,5]

TOPAZ-1
TOPAZ-1 was a randomised, double-blind, placebo controlled, multicentre, global Phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer. Patients with ampullary carcinoma were excluded.

The primary endpoint was OS and key secondary endpoints included progression-free survival, objective response rate and safety. The trial was conducted in 105 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan and China.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. 

Imfinzi is also approved in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC) in the US, EU, Japan and many other countries based on the HIMALAYA Phase III trial.

In addition to its indications in gastrointestinal (GI) cancers, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial results, which have been confirmed in the real-world setting in the PACIFIC-R study.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. Imfinzi is approved in previously treated patients with advanced bladder cancer in a small number of countries. 

Since the first approval in May 2017, more than 200,000 patients have been treated with Imfinzi. 

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, and other solid tumours. In 2023, AstraZeneca announced positive results for Phase III trials including combinations with Imfinzi in ovarian (DUO-O) and endometrial (DUO-E) cancers with Lynparza (olaparib), as well as in resectable NSCLC (AEGEAN) and in liver cancer eligible for embolisation (EMERALD-1). In June 2023, Imfinzi added to standard-of-care neoadjuvant chemotherapy met a key secondary endpoint of pathologic complete responses in the MATTERHORN Phase III trial.

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.[8]

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

In addition to its indications in BTC and HCC, Imfinzi is being assessed in combinations, including with Imjudo, in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is approved in the US and several other countries for HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. 

Lynparza, a first-in-class PARP inhibitor, is approved the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). 

AstraZeneca also has a global exclusive license agreement with KYM Biosciences Inc. for AZD0901. AZD0901 is a potential first-in-class antibody drug conjugate targeting Claudin 18.2, a promising therapeutic target in gastric cancer, currently in Phase I development.

AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body's immune system to attack tumours.

AstraZeneca aims to reimagine cancer care and help transform outcomes for patients with Imfinzi as a single treatment and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also exploring next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer.

AstraZeneca is boldly pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca (https://www.linkedin.com/company/astrazeneca/). 

Contacts
For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1. Marcano-Bonilla L, et al. Biliary tract cancers: epidemiology, molecular pathogenesis and genetic risk associations. CCO. 2016;5(5). 
2. ESMO. What is Biliary Tract Cancer. Available at: https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf. Accessed November 2023. 
3. Ouyang G, et al. The global, regional, and national burden of gallbladder and biliary tract cancer and its attributable risk factors in 195 countries and territories, 1990 to 2017: A systematic analysis for the Global Burden of Disease Study 2017. Cancer. 2021;127:2238-2250. 
4. Chen S, et al. Current status, trends, and predictions in the burden of gallbladder and biliary tract cancer in China from 1990 to 2019. Chin Med J (Engl). 2022;135(14):1697-1706. 
5. Turkes F, et al. Contemporary Tailored Oncology Treatment of Biliary Tract Cancers. Gastroenterol Res Pract. 2019;2019:7698786.
6. Rawla P, et al. Epidemiology of gallbladder cancer. Clin Exp Hepatol. 2019;5(2):93-102. 
7. Banales JM, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557-588. 
8. WHO. World Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed November 2023