Pharmacyclics presents new data to support Xcytrin for brain cancer

By Elaine Rigoli

Tampa, Fla., June 5 - Pharmacyclics, Inc. said that according to new data analyses, Xcytrin (motexafin gadolinium) injection, adjusted for treatment-arm imbalances in the company's phase 3 trial, appeared to significantly prolong time to neurologic progression, the primary endpoint of the study, in non-small cell lung cancer patients with brain metastases.

The trial enrolled 554 patients at 94 centers in North America, Europe and Australia and compared the safety and efficacy of WBRT alone to WBRT plus Xcytrin.

The three largest enrolling areas were North America (63%), France (21%) and Germany (8%).

The primary pre-specified endpoint of time to neurologic progression was measured from the date of randomization on the study to the time of neurologic progression as determined by a blinded events review committee.

Results from the trial indicated that there were substantial differences in the management of patients with brain metastases in North America versus Europe, particularly in France.

In some centers in France, there was a significant treatment delay between diagnosis and randomization on the trial, according to a news release.

Overall, mean time from brain metastases diagnosis to randomization for the Xcytrin arm was 4.3 weeks versus 3.3 weeks for the control arm, an imbalance that adversely affected outcomes in the Xcytrin arm of the study, the release said.

In the intent-to-treat population of 554 patients, the median time to neurologic progression was 15.4 months for those receiving WBRT plus Xcytrin compared to 10.0 months for patients treated with WBRT alone, a trend in favor of the Xcytrin-treated arm.

However, analyses correcting for the imbalance in treatment delay showed that, in the intent-to- treat population, median time to neurologic progression was 15.5 months for those receiving WBRT plus Xcytrin compared to 10.2 months for the control arm, the release said.

Pharmacyclics is a pharmaceutical company located in Sunnyvale, Calif.

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