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Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL
Date:12/9/2008

s and 19.1 months, respectively.

"Data show that some people with CLL who have 17p abnormalities may have poor outcomes and may not respond as well to standard chemotherapeutic agents," said lead investigator Michael Fiegl, MD, Department of Internal Medicine, Academic Natters Hospital, Natters, Austria. "This analysis showed activity in patients across all cytogenetic categories -- including high risk patients with 17p deletion and in patients where conventional chemotherapy has failed. The results of this analysis warrant further prospective, clinical studies in patients with 17p deletion."

A second study (abstract #2095) evaluated a combination of cyclophosphamide, fludarabine, alemtuzumab (Campath) and rituximab (CFAR) as a frontline therapy in high-risk CLL patients. Of the 48 patients evaluated in this ongoing trial, 28 percent had 17p deletion. In the total cohort, treatment with the CFAR regimen resulted in an ORR of 94 percent and a CRR of 69 percent. In patients with 17p deletion, treatment with the CFAR regimen resulted in an ORR of 77 percent and a CRR of 54 percent.

"Patients with 17p deletion who have active disease and need treatment are at high risk for lower complete and overall remission rate, shorter progression-free and overall survival," said lead investigator William G. Wierda, MD, PhD, assistant professor of medicine, M.D. Anderson Cancer Center, Houston, Texas. "In this analysis, Campath in combination with the FCR regimen showed activity in previously untreated patients with 17p deletion. The CFAR regimen may be a viable first-line therapy for patients in this population, although further study is warranted."

In a third multicenter study (abstract #329) of 103 CLL patients who were fludarabine refractory, unfavorable genetics were frequent (17p deletion: 29 percent, 11q deletion: 19 percent, unmutated IgVH: 68 percent, TP53 mutation: 34 percent). In this
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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