Ariad’s partner Merck initiates Phase II lung cancer trial

Ariad Pharmaceuticals, a developer of small-molecule drugs to treat cancer, has announced the initiation by Merck & Co, of a Phase II clinical trial to evaluate the safety and efficacy of oral deforolimus, Ariad’s investigational mTOR inhibitor, in patients with advanced non-small cell lung cancer.

Deforolimus is currently being studied in multiple clinical trials, both alone and in combination with other therapies, in patients with several different types of cancer. Under the terms of the agreement, Ariad will receive a $10 million milestone payment from Merck upon treatment of the first patient in this clinical study.

The multi-center, randomized, double-blind, placebo controlled clinical trial will compare oral deforolimus against placebo in patients with advanced non-small cell lung cancer whose tumors have a KRAS mutation. The presence of KRAS mutations in lung tumors is a recognized predictor of poor response to EGFR inhibitors such as erlotinib.

The trial utilizes a randomized discontinuation design in which all patients initially receive deforolimus. Those patients who respond to treatment will continue on therapy, while those whose disease is stable will be randomized to continued oral deforolimus or placebo.

Supportive care elements for patients are the same in the two arms of the study after randomization. This trial is designed to assess control of disease progression by oral deforolimus. The primary endpoint of the study is progression-free survival in the randomized population.

The clinical trial will enroll approximately 150 patients who have failed two prior treatment regimens. It will be conducted at approximately 38 sites including medical centers in the US and abroad.