AstraZeneca highlights continued progress of oncology pipeline at ASCO 2016

Leadership in DNA damage response therapies

73 abstracts presented at ASCO with 19 related to olaparib and new potential medicines targeting DNA damage response in multiple tumor types

Continued momentum of immuno-oncology medicines including new data on durvalumab in bladder cancer, underpinning the Breakthrough Drug Designation, and new data in first-line NSCLC

Further insights on osimertinib’s ability to penetrate the blood-brain barrier in patients with metastatic lung cancer, and acalabrutinib in chronic lymphocytic leukemia


AstraZeneca and its global biologics research and development arm, MedImmune, will provide an update on their extensive investigational oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3-7, 2016.

Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programs, and showcase small-molecule developments including osimertinib in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO, we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for olaparib. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year.”

DDR: a promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimize the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially help kill cancer cells, while theoretically minimizing the impact on normal cells, has potential for selective, reasonably tolerated therapies to hopefully improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor olaparib; WEE1 inhibitor AZD1775; ATM inhibitor AZD0156; ATR inhibitor AZD6738; and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to help prevent tumor cells from replicating.

At the ASCO congress, DDR presentations will highlight:

  • The potential for maintenance of DDR therapies as shown by olaparib overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a “Best of ASCO” abstract
  • Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with olaparib or a VEGFR inhibitor, cediranib, in women's cancers (Abstract # 3015)
  • The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (Abstract # 4041)
  • The potential of DDR therapies against multiple biological DDR targets in different tumor types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumors (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)

Immuno-Oncology: robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade - through the combination of durvalumab and tremelimumab - may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

  • Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
  • Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
  • New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
  • Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer [DANUBE trial] (Abstract # TPS4574) and SCCHN [KESTREL trial] (Abstract # TPS6101)
  • Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumors and sample age (Abstract # 3025)

Osimertinib in brain metastasis; acalabrutinib in CLL

At ASCO, new data will highlight the importance of osimertinib activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumor DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include a presentation on the potential of our potent, highly selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukemia (CLL):

  • Data from the BLOOM study of osimertinib in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC (Abstract # 9002)
  • Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
  • Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)
     

NOTES TO EDITORS

A Media Briefing on Saturday, June 4, 2016, 6:00-7:00 PM CDT, at the Hyatt Regency (room Columbus I-J) will update journalists on the latest advances in AstraZeneca’s Oncology portfolio being reported at ASCO. In addition, the briefing will focus on the potential of DDR therapies as a breakthrough paradigm in cancer treatment. If you are interested in attending, please contact:

An Investor Science Event on Monday, June 6, 2016, 7:00-8:30 PM CDT, will highlight the continuing momentum behind new developments in AstraZeneca’s Oncology therapy area.

Investors and analysts wishing to attend are invited to register here or contact the Investor Relations Team (details below).

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, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms — immuno-oncology, the genetic drivers of cancer 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.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas — respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology — as well as in infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.


CONTACTS

Media Inquiries

Michele Meixell +1 302 885 2677
 

Leadership in DNA damage response therapies

73 abstracts presented at ASCO with 19 related to olaparib and new potential medicines targeting DNA damage response in multiple tumor types

Continued momentum of immuno-oncology medicines including new data on durvalumab in bladder cancer, underpinning the Breakthrough Drug Designation, and new data in first-line NSCLC

Further insights on osimertinib’s ability to penetrate the blood-brain barrier in patients with metastatic lung cancer, and acalabrutinib in chronic lymphocytic leukemia


AstraZeneca and its global biologics research and development arm, MedImmune, will provide an update on their extensive investigational oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3-7, 2016.

Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programs, and showcase small-molecule developments including osimertinib in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO, we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for olaparib. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year.”

DDR: a promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimize the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially help kill cancer cells, while theoretically minimizing the impact on normal cells, has potential for selective, reasonably tolerated therapies to hopefully improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor olaparib; WEE1 inhibitor AZD1775; ATM inhibitor AZD0156; ATR inhibitor AZD6738; and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to help prevent tumor cells from replicating.

At the ASCO congress, DDR presentations will highlight:

  • The potential for maintenance of DDR therapies as shown by olaparib overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a “Best of ASCO” abstract
  • Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with olaparib or a VEGFR inhibitor, cediranib, in women's cancers (Abstract # 3015)
  • The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (Abstract # 4041)
  • The potential of DDR therapies against multiple biological DDR targets in different tumor types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumors (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)

Immuno-Oncology: robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade - through the combination of durvalumab and tremelimumab - may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

  • Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
  • Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
  • New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
  • Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer [DANUBE trial] (Abstract # TPS4574) and SCCHN [KESTREL trial] (Abstract # TPS6101)
  • Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumors and sample age (Abstract # 3025)

Osimertinib in brain metastasis; acalabrutinib in CLL

At ASCO, new data will highlight the importance of osimertinib activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumor DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include a presentation on the potential of our potent, highly selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukemia (CLL):

  • Data from the BLOOM study of osimertinib in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC (Abstract # 9002)
  • Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
  • Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)

NOTES TO EDITORS

A Media Briefing on Saturday, June 4, 2016, 6:00-7:00 PM CDT, at the Hyatt Regency (room Columbus I-J) will update journalists on the latest advances in AstraZeneca’s Oncology portfolio being reported at ASCO. In addition, the briefing will focus on the potential of DDR therapies as a breakthrough paradigm in cancer treatment. If you are interested in attending, please contact:

An Investor Science Event on Monday, June 6, 2016, 7:00-8:30 PM CDT, will highlight the continuing momentum behind new developments in AstraZeneca’s Oncology therapy area.

Investors and analysts wishing to attend are invited to register here or contact the Investor Relations Team (details below).

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, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms — immuno-oncology, the genetic drivers of cancer 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.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas — respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology — as well as in infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.


CONTACTS

Media Inquiries

Michele Meixell +1 302 885 2677


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