The trial was designed to compare the safety and efficacy of whole brain radiation therapy alone to brain radiation plus Xcytrin.
Although patients receiving Xcytrin had a longer time to neurologic progression than the control group, this difference did not achieve statistical significance.
The median time to neurologic progression was 15.4 months for patients receiving brain radiation plus Xcytrin compared to 10 months for patients treated with brain radiation alone.
“While we are disappointed the trial did not meet the primary endpoint, the data do show a favorable trend in this very sick, difficult-to-treat advanced lung cancer patient population,” said Dr Richard Miller, president and CEO of Pharmacyclics. “We believe this study demonstrates that Xcytrin has clinical activity in lung cancer and we will continue to focus resources on its potential use in the systemic therapy of this disease.”