Selumetinib was assessed 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 phase III SELECT-1 trial failed to meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival.
The adverse event profiles for selumetinib and docetaxel were consistent with those seen earlier, AstraZeneca said.
AstraZeneca executive vice president for global medicines development and chief medical officer Sean Bohen said the result was disappointing especially after promising results from the combination in a randomized phase II trial.
“We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments.”
The company expects to present data at a forthcoming medical meeting.
Selumetinib is an oral small-molecule MEK inhibitor invented by Array BioPharma and licensed to AstraZeneca.
Last year, selumetinib also failed to show a significant progression-free survival benefit in a late-stage study involving patients with metastatic uveal melanoma.
The drug is currently being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer (DTC), and patients with neurofibromatosis type 1.
In May this year, the US Food and Drug Administration granted selumetinib orphan drug designation for adjuvant treatment of patients with stage III or IV DTC.