AstraZeneca's once-lauded drug flunks a Phase III eye cancer trial

AstraZeneca's ($AZN) cancer treatment selumetinib failed to significantly prolong survival in a study on melanoma that has spread to the eye, a late-stage setback for a drug once considered a bright spot in the company's oncology pipeline.

In a 152-patient Phase III trial, a combination of selumetinib and the common chemotherapy dacarbazine failed to improve progression-free survival compared with the old drug alone, AstraZeneca said, declining to disclose detailed results. The target, uveal melanoma, is a rare form of cancer in which tumor cells grow in ocular tissue, affecting about 2,000 Americans each year.

Selumetinib's failure comes on the heels of some promising mid-stage data in which the treatment more than doubled progression-free survival in uveal melanoma patients, jumping from 7 weeks in the chemotherapy arm of the study to 15.9 weeks in the drug arm. Those results, presented at 2013's American Society of Clinical Oncology meeting, stoked hopes that AstraZeneca was on track to win the first ever approval for uveal melanoma, which has no effective therapies.

The drug, licensed from Array Biopharma ($ARRY) back in 2003, is in the midst of a Phase III trial on advanced non-small cell lung cancer, its primary target, as well as a late-stage study in thyroid cancer and Phase II test in the rare neurofibromatosis. The company believes selumetinib's uveal melanoma failure has no read-through to those ongoing efforts, AstraZeneca oncology head Antoine Yver said in a statement.

Meanwhile, AstraZeneca is banking on its oncology pipeline to spur a turnaround in drug sales. CEO Pascal Soriot has promised to deliver annual revenue above $45 billion by 2023, with $12 billion of that figure coming from a trio of cancer drugs not including selumetinib. Perhaps most promising is MEDI4736, an antibody designed to help the immune system better combat tumors.

- read the statement

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