TREANDA Plus Rituximab - relapsed NHL

[Guest guest]

Journal of Clinical Oncology Publishes Study of Cephalon Medication

TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma

[study Reports 92 Percent Response Rate to Combination Treatment]

http://investors.cephalon.com/phoenix.zhtml?c=81709 & p=irol-newsArticle & ID=117493\

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FRAZER, Pa., July 15 /PRNewswire-FirstCall/ --

Cephalon, Inc. (Nasdaq: CEPH) announced today that in a phase 2 study

published online today in the Journal of Clinical Oncology, 92

percent of patients with relapsed indolent B-cell and mantle cell

non-Hodgkin's lymphoma (NHL) responded to treatment with TREANDA®

(bendamustine hydrochloride) for Injection plus rituximab. This

combination study is one of three studies in patients with NHL that

Cephalon submitted in December 2007 to the U.S. Food and Drug

Administration requesting approval of TREANDA for the treatment of

patients with indolent NHL who have progressed during or following

treatment with rituximab or a rituximab-containing regimen. TREANDA

was approved by the FDA in March 2008 for the treatment of patients

with chronic lymphocytic leukemia and is not currently approved for use in NHL.

" A variety of treatment options have been employed in patients with

indolent B-cell and mantle cell lymphomas, but resistance to

treatment in this patient population often limits effective

therapeutic options, " said Dr. , Vice President,

Worldwide Clinical Research at Cephalon. " Based on what we saw in

this study, the combination of TREANDA with rituximab appears to

elicit a high rate of durable responses and encouraging

progression-free survival. "

About the Study

In this multi-center, open-label, single arm, Phase 2 study, 66

patients with relapsed, indolent B-cell or mantle cell lymphoma

without documented resistance to prior rituximab therapy were

treated. Patients received rituximab 375 mg/meter squared

intravenously on day one and TREANDA 90 mg/meter squared

intravenously on days two and three of a 28-day cycle for up to six

cycles. An additional dose of rituximab was given one week before the

first cycle and four weeks after the last cycle.

Overall response rate was 92 percent with a complete response rate

(CR) of 41 percent. A CR means that after treatment with the TREANDA

and rituximab combination, patients had no detectable evidence of

disease. These responses were durable, with a median duration of 21

months overall (19 months for the mantle cell population).

Additionally, the combination of TREANDA and rituximab was associated

with progression-free survival (PFS) of 23 months overall and for

patients with mantle cell lymphoma.

In this published study, the combination of both treatments was

generally well tolerated. The most common adverse events in the trial

included myelosuppression (a condition in which bone marrow activity

is decreased), nausea, infection, fatigue, constipation, and diarrhea.

This combination study is one of three studies in patients with NHL

that Cephalon submitted to the FDA in December 2007 requesting

approval of TREANDA for the treatment of patients with indolent NHL

who have progressed during or following treatment with rituximab or a

rituximab-containing regimen. The other two studies evaluated the

efficacy and safety of TREANDA as monotherapy in this patient

population. In all three studies, patients treated with TREANDA had a

high rate of response and a manageable side effect profile, with

myelosuppression as the most common side effect. Cephalon anticipates

a review decision on this application by the agency by October 31, 2008.

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