AstraZeneca Late-Stage Orphan Cancer Drug FailsBy
AstraZeneca has announced that its anti-cancer drug, selumetinib, failed to meet its primary endpoint in a Phase III clinical trial for a specific form of lung cancer. Selumetinib did not have a significant effect on overall survival. The drug is a mitogen-activated protein kinase (MAPK) kinase (MEK) 1/2 inhibitor, which was in a Phase III trial in combination with docetaxel chemotherapy as a second-line treatment in patients with KRAS mutation-positive (KRASm) locally advanced or metastatic non-small cell lung cancer (NSCLC). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.
AstraZeneca acquired exclusive worldwide rights to selumetinib in 2002 from Array BioPharma, based in Boulder, Colorado. Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer and in patients with neurofibromatosis Type 1, a genetic disorder that causes tumors to grow along nerve tissue.
In May 2016, selumetinib was granted orphan drug designation by the US Food and Drug Administration for adjuvant treatment of patients with Stage III or IV differentiated thyroid cancer.