AstraZeneca: Selumetinib Fails To Meet Trial Endpoint In KRASm NSCLC Patients

(RTTNews) - British drug maker AstraZeneca Plc. (AZN, AZN.L) Tuesday announced that Phase III SELECT-1 trial of Selumetinib did not meet primary endpoint in patients with KRAS mutation-positive or KRASm locally-advanced or metastatic non-small cell lung cancer or NSCLC.

The results showed that the trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment, did not meet its primary endpoint of progression-free survival, and selumetinib did not have a significant effect on overall survival.

The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.

SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib or placebo in combination with docetaxel.

Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. (ARRY) in 2003.