AstraZeneca melanoma drug enters phase II

AZD6244 is a selective MEK inhibitor that was in-licensed by AstraZeneca from Array in December 2003. AstraZeneca expects the first patient to be enrolled in this melanoma study before the end of June, which will trigger a $3 million milestone payment to Array upon dosing the first patient.

The trial is a randomised phase II study that will compare AZD6244 to temozolomide in the treatment of stage III / IV melanoma. AstraZeneca expects to enroll up to 180 patients at approximately 40 centers worldwide.

Additional phase II studies, in a range of other tumors, are scheduled to start over the next two to three months. The company said that it believes AZD6244 will be the first MEK inhibitor to be evaluated in randomized phase II studies.

Initiation of the phase II study is based on the results of the phase I study which recently completed recruitment, and which included patients with melanoma and a variety of other solid tumors. The phase I study clearly demonstrated that AZD6244 inhibits MEK and associated downstream markers in tumors at doses deemed well tolerated.

Array was responsible for filing the IND and conducting the phase I clinical testing of AZD6244. AstraZeneca is responsible for all other aspects of clinical development and commercialization.

“Array has delivered an extremely successful phase I study and has brought AZD6244 to this important milestone and transition,” said Brent Vose, vice president and head of Oncology & Infection, AstraZeneca. “We are now looking forward to building on the significant contribution made by Array and to continuing to move forward with the development of this compound, which we believe has the potential to bring real benefits to people with cancer.”