AstraZeneca Reports Failure in Phase 3 Lung Cancer Trial

Selumetinib did not meet trial endpoints in patients with KRASm-positive non-small cell lung cancer.

AstraZeneca revealed that its anticancer drug, selumetinib, failed to meet primary endpoints in a phase 3 clinical trial of KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer.

The drug is an orally administered MEK 1/2 inhibitor. MEK 1/2 are crucial aspects of the RAS-ERK pathway in patients with this type of lung cancer. Results from the phase 3 trial, SELECT-1, show that selumetinib failed to meet primary and secondary endpoints.

Included in the trial were 510 patients with KRAS mutation-positive lung cancer, who received either selumetinib or placebo in combination with docetaxel. Researchers found that selumetinib in combination docetaxel did meet its primary endpoint, which was progression-free survival, according to AstraZeneca.

Selumetinib also did not have a significant effect on overall survival and, therefore, would not be an effective second-line treatment for these patients. In addition to overall survival, secondary endpoints included objective response rate, duration of response, safety, and tolerability.

However, AstraZeneca said that the drug received Orphan Drug Designation for patients with differentiated thyroid cancer. Selumetinib is also set to be explored as an option for the treatment of patients with neurofibromatosis type 1.

“A randomized phase 2 trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation-positive lung cancer. It is disappointing for patients that these results have not been confirmed in phase,” said Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca. “We expect to present data at a forthcoming medical meeting. We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments.”