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Journal of Clinical Oncology, volume 24, issue 1
Affirm Survival Benefit of EFAPROXYN(TM) in Patients with Brain Metastases Originating From Breast Cancer
Allos Therapeutics, Inc. today announced the publication of results from its Phase 3 REACH study of EFAPROXYN (efaproxiral) in patients with brain metastases. Results of the study, which were reported in the January 1st edition of the Journal of Clinical Oncology, suggest that the addition of EFAPROXYN to whole brain radiation therapy (WBRT) may improve survival and response rates in patients with brain metastases, particularly those from breast cancer.
Authors of the manuscript analyzed data from the REACH study to assess the safety and efficacy of EFAPROXYN when administered as an adjunct to WBRT in patients with brain metastases from various solid tumors. Among the subgroup of 397 patients with non-small cell lung cancer (NSCLC) or breast cancer, results of the analysis indicated that there was an improvement in both response rate and median survival time for patients in the EFAPROXYN arm. Median survival time (MST) for the NSCLC/breast cancer subgroup was 6.0 months for the EFAPROXYN arm versus 4.4 months in the control arm (HR=0.82, p=0.07), an improvement of 38%. A Cox multiple regression analysis conducted to account for known predictors of survival in this heterogeneous patient population demonstrated a 25% reduction in the risk of death (HR=0.75, 95% CI: 0.60, 0.94; p=0.01) for patients in the EFAPROXYN arm. A statistically significant improvement (13%, p=0.01) in response rate (radiographic complete plus partial response) was also observed for patients in the EFAPROXYN arm in the NSCLC/breast cancer subgroup. In an exploratory analysis by primary tumor type, the largest EFAPROXYN treatment effect was observed in the 107 eligible patients with brain metastases originating from breast cancer (HR=0.51, p=0.003, unadjusted log-rank). Overall, EFAPROXYN was very well tolerated, with the majority of EFAPROXYN-related adverse events being grade 1 and 2. All adverse events were resolved within the 1-month follow-up period and were easily managed with supportive care. A portion of these data were previously presented at the 40th Annual Meeting of the American Society of Clinical Oncology, the 26th Annual San Antonio Breast Cancer Symposium and the 8th Annual Scientific Meeting of the Society for Neuro-Oncology.
"Our findings suggest that EFAPROXYN has the potential to improve the survival of a group of patients with an otherwise very poor prognosis," said John H. Suh, M.D., Director of the Gamma Knife Center, Radiation Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation and the study´s principal investigator. "Results of this study are particularly compelling in light of the lack of progress made by the field over the past 25 years in extending the survival and quality of life of this patient population."
To further confirm the survival benefit observed in the breast cancer subgroup in the REACH trial, in February 2004, the Company initiated a Phase 3, randomized, open-label, multi-center trial called ENRICH (Enhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), designed to compare the effect of WBRT with supplemental oxygen with or without EFAPROXYN in women with brain metastases from breast cancer. The Company currently expects to complete patient enrollment in the ENRICH trial during the second half of 2006 and report preliminary results approximately six months thereafter.
01/03/2006