AstraZeneca’s cancer drug selumetinib has failed a late-stage clinical trial in uveal melanoma, a rare disease in which cancer cells grow in the tissues of the eye.
The phase III SUMIT trial of selumetinib in combination with dacarbazine for metastatic uveal melanoma did not meet its primary endpoint of progression free survival.
However, AZ noted that the trial did not show major changes to the combination’s current adverse event profile, which it said was generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib.
The trial setback comes three months after the US FDA granted selumetinib Orphan Drug Designation in recognition of the need for new, safe and effective therapies for the disease.
An important pipeline product for AstraZeneca, selumetinib is primarily being developing in non-small cell lung cancer – where it has reached phase III, and the MEK inhibitor is also at phase III in thyroid cancer and phase II in the nerve tumour condition neurofibromatosis type 1.
Antoine Yver, head of oncology, Global Medicines Development at AstraZeneca, said: “Selumetinib is supported by a strong development programme with different scientific rationale inmultiple tumour types as both monotherapy and in alternative combinations.”
He added: “The findings from SUMIT have no impact on the other studies and we look forward to presenting the data in due course.”