BioCentury
ARTICLE | Clinical News

AZ reveals another Phase III selumetinib miss

July 27, 2018 12:04 AM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) disclosed in its 2Q18 earnings that it discontinued development of selumetinib to treat differentiated thyroid cancer after the candidate missed the primary endpoint in the Phase III ASTRA trial in the indication. In the 233-patient trial, twice-daily 75 mg oral selumetinib for five weeks plus a single dose of radioactive iodine given about 30 days after randomization did not significantly improve complete remission rate at 18 months post-radioactive iodine therapy vs. placebo plus radioactive iodine. Full data will be presented at a medical meeting.

The ASTRA miss marks the third Phase III trial in which the small molecule inhibitor of MAP kinase kinase 1 (MAP2K1; MEK1) and MAP2K2 has missed the primary endpoint. The product previously failed a pair of Phase III trials to treat K-Ras (KRAS) mutation-positive non-small cell lung cancer (NSCLC) and metastatic uveal melanoma, respectively...