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

Selumetinib has already failed in two other types of cancer over the past three years. (AstraZeneca)

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).


Webinar: Optimizing Oncology Trials with a ctDNA Test Custom-Built for MRD and Molecular Monitoring

Join this webinar to discover the advantages of using Signatera™ (RUO), a novel assay custom-designed for each patient that detects circulating tumor DNA (ctDNA) with high sensitivity and specificity to monitor molecular residual disease, early recurrence, and treatment response across solid tumors.

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.

RELATED: AstraZeneca lung cancer trial falls short in PhIII

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: “selumetinibthyroid cancerdid 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.

Suggested Articles

Cornell researchers found that inhibiting a long noncoding RNA called SAF caused HIV-infected cells to self-destruct.

Liquid biopsy developer Epic Sciences has brought on Myriad Genetics’ oncology chief, Lloyd Sanders, to be its new president and CEO.

Thermo Fisher Scientific has moved to acquire viral vector developer and manufacturer Brammer Bio for $1.7 billion in cash.