Array BioPharma's experimental drug to treat advanced melanoma failed to meet its main goal in a mid stage trial. The drug AZD6244 (ARRY-886) was jointly developed by Array and AstraZeneca. However, based on the results of the study, AstraZeneca does not plan to progress AZD6244 as a monotherapy into a phase III trial in patients with advanced melanoma at this time, although anti-tumour activity was detected.

The randomised phase II study comparing AZD6244 (ARRY-886) monotherapy with temozolomide (Temodar, an alkylating agent), an oral cancer treatment drug made by Schering Plough, reported no apparent difference in efficacy between AZD6244 and temozolomide for the primary endpoint (Progression Free Survival), said the company in a recent press release. AstraZeneca, which licensed AZD6244 from Array in 2003, was responsible for running the phase II trial.

Based on the results of this study, AstraZeneca does not plan to progress AZD6244 as a monotherapy into a phase III trial in patients with advanced melanoma at this time, although anti-tumour activity was detected. AstraZeneca is exploring other options to further develop this compound.

In addition, AstraZeneca recently completed analysis on two smaller monotherapy signal searching studies in 3rd line advanced colorectal cancer (CRC) and 2nd line advanced non-small cell lung cancer (NSCLC). Neither of these studies reached their primary endpoint of delaying disease progression versus the randomised comparators in the overall population; however, there was evidence of anti-tumour activity in the NSCLC study.

The data from these studies will be presented at forthcoming medical congresses, the company officials said. AstraZeneca remains committed to the evaluation of MEK inhibitors and to better define their use in oncology clinical practice.

AZD6244 is an anti-cancer drug in Phase II development in a range of tumours. It is a small molecule inhibitor that targets a key position in the Ras/Raf/MEK/ERK signalling pathway. This pathway is implicated in the development and progression of cancers.

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation of targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas.