AstraZeneca’s selumetinib flops in thyroid cancer, adding to list of failures

As it has been tussling over licensing checks and trying to gain a reprieve, AstraZeneca quietly announced in the midst of its quarterly update this morning that selumetinib has once again missed the mark in a cancer test.

Just over two years ago, the British Big Pharma gained an orphan drug tag for its investigational MEK 1/2 inhibitor selumetinib in certain patients with thyroid cancer.

This was a comeback for the little drug that couldn’t: Back in August 2016, AZ said that selumetinib failed to improve either progression-free or overall survival in patients with KRAS mutation-positive non-small cell lung cancer (NSCLC).

That came around a year after the drug, in combo with dacarbazine, flopped in a late-stage effort in patients with metastatic uveal melanoma after not meeting its progression free survival target.

AstraZeneca then rolled the dice once more with the eponymous ASTRA trial, but lost the bet. In its trial update presentation published today, the company says simply that: "selumetinib—thyroid cancer—did not meet primary endpoint."

It has also "been removed from phase 3" in this indication, according to the update.

Previous results from a midstage study of selumetinib in patients with advanced thyroid cancer showed "clinically meaningful increases" in iodine uptake and retention in patients with thyroid cancer that was refractory to RAI.

The drug was licensed by AZ from Array Biopharma, but there have been some legal spats over money. Array, an AstraZeneca partner since 2003, says the Cambridge, U.K.-based drug giant has refused to pay royalties on selumetinib, a drug it invented and licensed to AZ.

Under a 2003 licensing deal, Array said earlier this year that it’s owed 12% of the proceeds AZ receives when it sublicenses selumetinib to other companies. In this case, the Colorado biotech is arguing AstraZeneca breached its contract and must pay $192 million based off the $1.6 billion upfront payment from Merck it made last summer, which included work on the MEK 1/2 inhibitor.

The drug is still in trials for the treatment of neurofibromatosis type 1, a rare and incurable genetic condition, as well as in early-stage combo trials with other meds.

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