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."
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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 melanomas1,2. 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.
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.
Egan KM, et al. Epidemiologic aspects of uveal melanoma. Surv Ophthalmol 1988;32:239–51
Ramaiya KJ, Harbour JW. Current management of uveal melanoma. Expert Rev Ophthalmol 2007; 2:939–46
US Food and Drug Administration. Developing Products for Rare Diseases & Conditions. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm Accessed on 08 July 2015
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