ALLOS REPORTS EFAPROXYN TRIAL DATA

Allos Therapeutics has reported data from its Phase III clinical trial of the investigational radiation sensitizer Efaproxyn (efaproxiral) in patients with brain metastases. The REACH study compared the survival benefit of brain metastases patients receiving Efaproxyn with whole-brain radiation therapy (WBRT) to those receiving WBRT alone. Results of the analysis indicated that the addition of Efaproxyn to WBRT led to a statistically significant increase in survival for Efaproxyn-arm patients with brain metastases originating from breast cancer.

The study was a randomized, open-label clinical trial designed to demonstrate the safety and efficacy of Efaproxyn in treating patients with brain metastases from various solid tumors and good performance status. Patients with small cell lung cancer, germ cell tumors or lymphoma were excluded. Prior brain tumor resection was allowed as long as measurable lesions remained.

The study enrolled 538 patients and compared the safety and efficacy of Efaproxyn plus WBRT and supplemental oxygen (271 patients) versus WBRT and supplemental oxygen (267 patients) alone in patients with brain metastases. The primary endpoint of the trial was survival. Although the difference in overall survival between patients who received Efaproxyn plus WBRT and patients who received WBRT alone was not statistically significant, the trial showed a positive survival benefit among patients with brain metastases originating from breast cancer.