Study Suggests that Lumiliximab May be Synergistic with Fludarabine

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Phase I/II Data Support Continued Development Of Biogen Idec's Novel

Anti-Cd23 Antibody For Chronic Lymphocytic Leukemia

Article Date: 02 Jan 2007 - 0:00 PST

Biogen Idec (Nasdaq: BIIB) Biogen Idec announced data from a Phase

I/II study of an investigational anti-CD23 monoclonal antibody,

lumiliximab, suggesting it may be synergistic with fludarabine,

cyclophosphamide and rituximab (FCR), an emerging standard of care

for chronic lymphocytic leukemia (CLL) patients. When added to the

FCR regimen, lumiliximab demonstrated a 52 percent complete response

(CR) rate in patients who have CLL that was progressing after prior

therapy. The data were announced at the 48th Annual Meeting of the

American Society of Hematology (ASH), being held December 9-12 in

Orlando.

In the lumiliximab study of 31 patients, lumiliximab added to the

FCR regimen achieved a 52 percent CR. CR rate is a predictor of

progression-free survival in CLL patients. Based on the positive

results of the trial, Biogen Idec is initiating a registrational

global, multicenter clinical trial comparing lumiliximab plus FCR

vs. FCR alone.

" The CD23 antibody is a promising therapeutic approach for this

disease because the antigen is highly expressed on B-CLL cells, "

said C. Byrd, M.D., D. Warren Brown professor of Leukemia

Research, director, Hematologic Malignancies Program, The Arthur

Comprehensive Cancer Center, The Ohio State University. " The

results from this study - including a 52 percent complete response

rate - support our hypothesis that lumiliximab may operate in

synergy with the FCR regimen to improve clinical outcomes. This new

targeted therapy may help us improve upon therapeutic options for

CLL patients. "

The ASH meeting is the first time a complete response data set has

been presented on this investigational novel anti-CD23 monoclonal

antibody, which may be a first in class therapy. Biogen Idec owns

the full worldwide rights to lumiliximab.

Thirty-one patients with relapsed CLL enrolled in this study of

lumiliximab in combination with FCR. An overall response rate of 71

percent was demonstrated: 52 percent CR, 10 percent partial response

(PR), and 13 percent unconfirmed PR. Response was generally achieved

after three to five cycles of therapy. In this study, lumiliximab in

combination with FCR appears to be well tolerated as compared to

what would be expected from FCR alone.

" The lumiliximab results support the initiation of a randomized,

registrational study in CLL. We continue to support our strong

pipeline in hematologic malignancies and solid tumors, " said

Parkinson, M.D., senior vice president, Oncology Research and

Development, Biogen Idec. " At Biogen Idec, we are dedicated to

creating new and novel approaches to cancer treatment that can make

a significant difference in patients' lives. "

About the Study

The study is an open label, dose escalation, multi-center Phase I/II

study (Study 152-30). Patients 18 years of age or older with

relapsed CD23+ B cell CLL were eligible. Patients enrolled had

progressive, symptomatic CLL as defined by National Cancer Institute

(NCI) criteria, a median age of 58, and had undergone a median of

two prior treatments (range, 1 to 9).

The FCR treatment regimen was used in this trial because it has been

established as the emerging standard of care for CLL patients. A

study conducted at The MD Cancer Center demonstrated that

the FCR regimen was an active and well-tolerated treatment for

previously treated patients with CLL, and achieved a complete

response rate (CR) of 25 percent (Weirda et al, Journal of Clinical

Oncology, Vol 23, No 18 (June 20), 2005: pp. 4070-4078).

In the study, 31 patients received either 375 mg/m2 (n=3) or 500

mg/m2 (n=28) of lumiliximab in combination with a 28-day cycle of

FCR for up to 6 cycles. Currently, baseline cytogenetic data is

available for 21 patients who received 500 mg/m2 of lumiliximab. The

majority of patients (74 percent) were Rai Stage I/II. Twenty

patients experienced a Grade 3 or 4 adverse event, (all of which

were hematologic toxicities commonly associated with the FCR

regimen). The most common study-related adverse events included

nausea (77 percent), pyrexia (61 percent), chills (55 percent),

neutropenia (55 percent) and fatigue (48 percent). Response was

evaluated at weeks 13 and 25 using the National Cancer Institute

Working Group (NCI-WG) criteria.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and

immunology. As a global leader in the development, manufacturing,

and commercialization of novel therapies, Biogen Idec transforms

scientific discoveries into advances in human healthcare. For

product labeling, press releases and additional information about

the company, please visit http://www.biogenidec.com.