AstraZeneca provides update on selumetinib

22 July 2015

AstraZeneca today announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival.This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing.

Selumetinib is a MEK inhibitor in late-stage development, with a primary programme in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase III study in differentiated thyroid cancer and in a Phase II registration study in patients with neurofibromatosis Type 1.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “Selumetinib is supported by a strong development programme with different scientific rationale in multiple tumour types as both monotherapy and in alternative combinations. The findings from SUMIT have no impact on the other studies and we look forward to presenting the data in due course.”

– ENDS –

NOTES TO EDITORS

About Selumetinib in Uveal Melanoma

Selumetinib, licensed from Array BioPharma Inc.in 2003, inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumour from growing.

The Selumetinib in Uveal Melanoma Investigator Trial (SUMIT) is a randomised, double-blind, placebo controlled trial being carried out in 45 centres, across 11 countries.

Uveal melanoma is an orphan disease in which cancer cells grow in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas^1,2. There are currently no effective treatments for advanced uveal melanoma and in April 2015, selumetinib was granted Orphan Drug Designation by the US Food and Drug Administration in recognition of the need for new, safe and effective therapies for the disease³.

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has a deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas - ovarian, lung, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, 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.com.

References

• 1.Egan KM, et al. Epidemiologic aspects of uveal melanoma. Surv Ophthalmol 1988;32:239–51

• 2.Ramaiya KJ, Harbour JW. Current management of uveal melanoma. Expert Rev Ophthalmol 2007; 2:939–46

• 3.US Food and Drug Administration. Developing Products for Rare Diseases & Conditions. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm Accessed on 08 July 2015

CONTACTS

Media Enquiries
Esra   Erkal-Paler	UK/Global	+44 20 7604   8030
Vanessa   Rhodes	UK/Global	+44 20   7604 8037
Ayesha   Bharmal	UK/Global	+44 20   7604 8034
Jacob   Lund	Sweden	+46   8 553 260 20
Michele   Meixell	US	+ 1 302   885 6351
Investor   Enquiries
UK
Thomas Kudsk Larsen		+44 20 7604 8199	+44 7818 524185
Eugenia Litz	Respiratory, Inflammation and   Autoimmunity	+44 20 7604 8233	+44 7884 735627
Nick Stone	Cardiovascular and Metabolic Disease	+44 17   6326 3994	+44 7717 618834
Karl Hård	Oncology	+44 20 7604 8123	+44 7789 654364
Craig Marks	Infection, Neuroscience and   Gastrointestinal Disease	+44 20 7604 8591	+44 7881 615764
Christer Gruvris		+44 20 7604 8126	+44 7827 836825
US
Dial / Toll-Free		+1 301   398 3251	+1 866 381 7277