Last accessed March 2018 Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? (MYSTIC). Antonia S, et al. The deal includes the British group buying a 9.8 percent stake in … ii The data cut-off date for analysis of OS, PFS and ORR was 11 March 2019. iii PFS was not formally tested for statistical significance. This website is intended for people seeking information on AstraZeneca's worldwide business. About AstraZeneca’s approach to Immuno-Oncology (IO). Please refer to your approved national product label (SmPC) for current product information. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in 10 countries, including the US. Imfinzi, developed by AstraZeneca, is a monoclonal antibody that binds to the PD-L1 checkpoint protein expressed by cancer cells to overcome the body’s immune system. BioPharma. At AstraZeneca, we’re continuing to better understand the important role of eosinophils as key effector cells in a range of potentially devasting inflammatory diseases, in which elevated eosinophils … 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. Szumera-Ciećkiewicz A, et al. By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death. Full-year and Q4 2017 Results Update. Patel S and R Kurzrock R. PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy. Adrian Kemp Advances in immuno-oncology. In 2002, its drug Iressa (gefitinib) was approved in Japan as monotherapy for non-small cell lung cancer. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial. I have read this warning and will not be using any of the contained product information for clinical purposes. The primary endpoint is OS. I have read this warning and will not be using any of the contained product information for clinical purposes. We are pursuing a comprehensive clinical trial programme that includes IO monotherapy and IO in combination with chemotherapies, small molecules, and other immunotherapies in multiple tumour types, stages of disease, and lines of therapy. The collaboration will focus on advancing mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including potential synergy with AstraZeneca … INO-3112 is a drug for immunotherapy, a new way of … Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC). 2000–06. Last accessed March 2018 AstraZeneca’s immunotherapy Imfinzi is a blockbuster drug but it won’t be generating U.S. sales in bladder cancer anymore. Available at https://clinicaltrials.gov/ct2/show/NCT03043872?term=CASPIAN&rank=1. Our vision is that IO will play a critical role in continuing to redefine the cancer treatment paradigm. In 1999, AstraZeneca identified a new location for the company's US base, the "Fairfax-plus" site in North Wilmington, Delaware. Ratcliff M et al. International Agency for Research on Cancer. AstraZeneca is plowing deeper into cancer immunotherapy through a wide-ranging deal with Innate Pharma. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso (osimertinib), and ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well as the Phase II combination trials SAVANNAH and ORCHARD.5-7. In comparison, the control arm allowed up to six cycles of chemotherapy and optional PCI. AstraZeneca is not responsible for the privacy policy of any third party websites. You are about to access AstraZeneca historic archive material. Important notice for users For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca. AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. LUNGevity Foundation. Onglyza 5mg pill. 2. Durvalumab+/- Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (Caspian). AstraZeneca provides this link as a service to website visitors. 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. The FDA approved Onglyza (saxagliptin) in 2009 to treat Type 2 diabetes. 6. Through these tests, AstraZeneca could gain an edge on the immuno-oncology leaders by rendering more people responsive to its drugs. iv Confirmed responses according to investigator assessment per RECIST v1.1. The goal of the PACIFIC trial, the first study in the Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 … Drugs that target PD-1 boost immune response against cancer cells and prevent PD-L1 proteins from binding and protecting PD-1s. Presented October 2016. http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=872#.WpjA11UrJhF, 9. 5. In September, AstraZeneca presented results of the PACIFIC Phase 3 clinical trials for Imfinzi in patients with NSCLC. Annals of Oncology 23 (Supplement 8): viii6-viii9, 2012  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 tumours. 2. Clinical Trials,gov. North America Cancer Immunotherapy Market Trends: Cyramza was launched by the Elli and Lilly company which is used for the treatment of metastatic non-small cell lung cancer. The safety and tolerability of Imfinzi in combination with SoC etoposide and platinum-based chemotherapy was consistent with previous trials. Date of Prep: 30 September 2020. Dive Brief: AstraZeneca and its biologics R&D arm MedImmune have acquired a 9.8% stake in Innate Pharma, along with rights to a slate of immuno-oncology drugs, in a deal which boosted the smaller company's share price by more than 40%. AstraZeneca is not responsible for the privacy policy of any third party websites. ClinicalTrials.gov. We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour 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. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 5. 4. AstraZeneca PLC. Cancer.Net. On June 15, we hosted a “White Out Cancer” event on AstraZeneca’s Gaithersburg, MD, campus encouraging our employees to join the cancer community and #WearWhite to raise awareness of immunotherapy, also called Immuno-Oncology (IO). 6 (June 1, 2018) 369-370. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal … The drug works through the CD47/SIRPa axis, targeting CD47 on cancerous cells and enabling myeloid cells to detect and kill them through their corresponding receptor, SIRPa. Alternatively, you can report any side effects of prescription drugs directly to the FDA. You are about to access AstraZeneca historic archive material. Pakkala, S, et al. ClinicalTrials.gov. The trial, called NEPTUNE, paired AstraZeneca's approved checkpoint inhibitor Imfinzi with its experimental drug tremelimumab, testing the two against platinum-based … The results were presented at the Presidential Symposium of the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain. The FDA's accelerated approval of Imfinzi in bladder cancer, granted in 2017, was based on tumor shrinkage and response data from an early-stage trial that tested the drug in different … The PD-L1 sector is the second largest sector within the immunotherapy drug market with $3.43 billion in sales in 2019 and projected to grow to $10.5 billion by 2024 (see Figure 1). Results showed that 61.5% of patients experienced a Grade 3 or 4 AE with Imfinzi plus SoC (all causes) vs. 62.4% with SoC, and patients discontinuing treatment due to AEs were similar between arms (9.4% vs. 9.4%). AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC). Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. The risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC). AstraZeneca’s immunotherapy drug scores key Phase III lung cancer win The company said the Phase III CASPIAN study of Imfinzi in first … Our country sites can be located in the AZ Network. 6. 2016;17:299-308. It is also noteworthy that these results may enable physicians to choose Imfinzi in combination with either cisplatin or carboplatin chemotherapy backbones. Accessed May 2019. 2011:29;2121-27. AstraZeneca and partner Bristol-Myers Squibb made hundreds of millions of dollars annually from Onglyza, but a study reported Onglyza increased the risk of hospitalizations due to heart failure. 2013:6;2800-12. Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.3 About three quarters of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body. The trial compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. Results showed a significantly higher progression-free survival (PFS) rate at 12 months (17.5% vs. 4.7%), a 10.3% increase in confirmed objective response rate (ORR) (67.9% vs. 57.6%), and improved duration of response (DOR) at 12 months (22.7% vs. 6.3%). Accessed May 2019. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. Company Secretary AstraZeneca provides this link as a service to website visitors. AstraZeneca today announced the start of the Phase III programme for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer (NSCLC) and other cancers. Key Points. Our country sites can be located in the AZ Network. We are using biomarkers as a decision making tool to define the best potential treatment path for a patient. First MedImmune oncology immunotherapy targeting the PD-L1/PD-1 pathway progresses into Phase III. World Health Organization. ESMO 2016 Poster. Available at https://www.cancer.net/cancer-types/33776/view-all. Clinical trials appendix. As part of a broad development programme, 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, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumours. Lancet Oncol. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. ... AstraZeneca's new drugs … Tagrisso is a new potential care for the patient specifically adults which is used to treat non-small cell drug launched by AstraZeneca plc in June 2017. A comparative study of PDL1 diagnostic assays in squamous cell carcinoma of the head and neck (SCCHN). Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. 3. This marked the fourth year we’ve hosted an onsite event to support Cancer Immunotherapy Month. J Clin Oncol. We encourage you to read the privacy policy of every website you visit. AstraZeneca still hopes to catch up in the advanced lung cancer market, too, by combining Imfinzi with another immunotherapy drug called tremelimumab. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. Clin Cancer Res 2013; 19: 997-100 AstraZeneca, through its research company called MedImmune, has just recently announced its decision to purchase a novel drug INO-3112 from Inovio, based in Pennsylvania, for a staggering price tag of $727 million. U.S. regulators have approved AstraZeneca’s key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars. ; The British pharma will pay $170 million upfront to pick up full rights to monalizumab, the subject of an earlier 2015 collaboration between the … 7. Imfinzi (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 tumour's immune-evading tactics and releasing the inhibition of immune responses. Mol Cancer Ther; 14:  847-856. Accessed July 2019. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Kalemkerian GP, et al. Types of Lung Cancer. Ellison G, et al. In the experimental arms, patients were treated with up to four cycles of chemotherapy. Eggermont A and Finn O. AstraZeneca has raised its bet on new treatments that harness the body's immune system to fight cancer by striking a drug development deal with private British biotech company Immunocore. The trial will continue to the final analysis of OS for the combination of Imfinzi, tremelimumab and chemotherapy. Accessed July 2019. 3. Veeva ID: Z4-25396Date of next review: August 2022. By Ben Hirschler LONDON (Reuters) - AstraZeneca's immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, opening up a multibillion-dollar market for a medicine that has so far lagged behind competitors. AstraZeneca. Please refer to your approved national product label (SmPC) for current product information. JCI Insight. Clinical development of immunostimulatory monoclonal antibodies and opportunities for combination. We look forward to working with regulatory authorities to bring Imfinzi to patients with small cell lung cancer around the world as soon as possible.”, Luis Paz-Ares, MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial said: “Patients have had limited treatment options for small cell lung cancer, a devastating disease where the five-year survival rate has been as low as 6%. We encourage you to read the privacy policy of every website you visit. The significant survival benefit demonstrated with Imfinzi combined with only four cycles of a choice of chemotherapy compared to a robust control arm, provides evidence and hope of a new treatment option for these patients.”, SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.1. A combination of two AstraZeneca immunotherapy drugs proved no better than standard chemotherapy in a Phase 3 study of patients with metastatic lung cancer, results disclosed Wednesday by the British pharma showed. (MEDIOLA). Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. About AstraZeneca. Finn O. Immuno-oncology: understanding the function and dysfunction of the immune system in cancer. i Etoposide plus investigator choice of cisplatin or carboplatin chemotherapy. Last accessed March 2018. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. “Despite progress in the field of immunotherapy… AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM and Respiratory. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. 10. Lung Cancer - Small Cell. Int J Clin Exp Pathol. The CASPIAN trial is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of patients with extensive-stage SCLC.