AstraZeneca’s selumetinib fails to meet primary endpoint in lung cancer trial again
pharmafile | August 9, 2016 | News story | Manufacturing and Production | AstraZeneca, failure, non-small cell lung cancer, phase III, selumetinib, trial failure
AstraZeneca has announced that its MEK 1/2 inhibitor, selumetinib, failed to meet its primary endpoint of progression free survival in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer.
The drug candidate failed to meet its primary endpoint in a 2011 Phase II trial in the same indication. In both trials, selutmetinib was used in combination with Sanofi chemotherapy drug Taxotere (docetaxel) as a 2nd line treatment.
AstraZeneca acquired exclusive worldwide rights to the drug from Array Biopharma for an upfront payment of $26.5 million. Array is eligible to receive milestone payments up to $70 million, as well as royalties on product sales.
The drug entered Phase III trials, despite missing the primary endpoint in Phase II, due to positive secondary endpoint results. At the time of initiation of the trial, head of oncology at AstraZeneca’s global medicines development unit, Antoine Yver, said: “SELECT-1 will be the first Phase III study to investigate whether a MEK inhibitor in combination with chemotherapy is superior to chemotherapy alone in KRAS mutation positive advanced or metastatic non-small cell lung cancer. This is an area of pressing clinical need.”
While the drug disappointed in this lung cancer indication, it was recently granted orphan drug designation from the US Food and Drug Administration in late-stage differentiated thyroid cancer.
It is also being trialled in patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.
At the time of writing, Array Biopharma stock has fallen 2%, while AstraZeneca’s remains largely unchanged.
Sean Murray
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