Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma
Tuesday July 15, 8:44 am ET
Study Reports 92 Percent Response Rate to Combination Treatment
FRAZER, Pa., July 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) 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. Charles Morris, 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.
surf's up......crikey
