Drug Development

Now a three-time loser, selumetinib continues to cause headaches as AstraZeneca dumps a failed PhIII

Selumetinib continues to cause big headaches at AstraZeneca $AZN.

The MEK inhibitor — now partnered with Merck $MRK in their big $8.5 billion alliance — failed a Phase III study for differentiated thyroid cancer, according to the Q2 report from AstraZeneca. And they quietly whisked that program out of the pipeline in a virtual footnote to its quarterly report.

The failure makes this drug a three-time loser, though it’s still in clinical trials.

Pascal Soriot

AstraZeneca was forced to concede two years ago that the drug flopped in KRAS-positive non-small cell lung cancer. Selumetinib whiffed on progression-free survival and failed to score on overall survival as well. And AstraZeneca had to walk away from the first Phase III for selumetinib in 2015 after the drug — in-licensed from Array — failed for an eye cancer called uveal melanoma.

Once upon a time selumetinib loomed large at AstraZeneca. Pascal Soriot confidently predicted that it could become a blockbuster as he made the case to investors that Pfizer’s buyout attempt should be firmly rejected. These days, you don’t hear too much about the blockbuster forecast or the 2017 filing Soriot outlined back when he asserted the company could achieve $45 billion in sales in 2023.

AstraZeneca did report a few months ago that the drug achieved orphan drug status for neurofibromatosis type 1. 

But therein lies a separate tale.

Array got angry with AstraZeneca for including selumetinib in the Merck partnership, filing a suit claiming that their big pharma partner breached its contract and had no right to strike a deal with Merck on neurofibromatosis. Array claimed that as it is due a 12% royalty on their deal, is owed $192 million on the $1.6 billion upfront that Merck paid to buy into AstraZeneca’s cancer pipeline. 

AstraZeneca, not surprisingly, takes an opposing opinion.

To be fair, AstraZeneca had plenty to boast about today when it came to their oncology group’s Q2 performance, with its big three Lynparza, Tagrisso and Imfinzi helping buoy expectations that the pharma giant will finally turn the corner with rising product sales this year. 


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