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Clinical Trials

Date: 2013-05-16

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of data from a study sponsored by the National Cancer Institute at ASCO

Company: AstraZeneca (UK)

Product: selumetinib

Action mechanism:

tyrosine kinase inhibitor/MEK inhibitor. Selumetinib is an oral, potent, selective MEK inhibitor, which has been shown to be effective as monotherapy and in combination with standard chemotherapy regimens in Phase I and Phase II clinical studies across a range of solid tumours, which support the development of selumetinib in patients with MEK-dependent cancers. MEK is part of the MAPK pathway which is frequently activated in cancer, and is elevated in many different solid tumour types, including those featuring the KRAS mutation, which is present in 20% of human cancers and 20-30% of NSCLC tumours.

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array. To date, Array received $26.5 million in up-front and milestone payments and is entitled to potential additional development milestone payments of approximately $70 million (with $30 million specific for selumetinib) and royalties on product sales.

Disease: advanced melanoma

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The Phase II data is from a randomised study of selumetinib compared with temozolomide (chemotherapy) in patients with metastatic uveal (eye) melanoma sponsored by the National Cancer Institute and from a double blind, randomised study of selumetinib in combination with dacarbazine as a first-line treatment for advanced cutaneous melanoma patients with BRAF mutations.

Latest news:

* On May 16, 2013, AstraZeneca has announced that data from a study sponsored by the National Cancer Institute will be presented at ASCO on selumetinib, a selective MEK kinase inhibitor, in patients with advanced uveal melanoma. Data from an AstraZeneca sponsored study in patients with advanced cutaneous melanoma that harbors a mutation of the BRAF gene will also be presented.
Selumetinib features in two oral presentations (abstract # CRA9003 in gnaq/Gna11 mutation positive uveal melanoma and abstract # 9004 in first-line treatment for advanced BRAF mutant cutaneous or unknown primary melanoma).

Is general: Yes