Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma

Monday, March 17, 2008 General News
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SEATTLE, March 17 Cell Therapeutics, Inc. (CTI)(Nasdaq: CTIC; MTA) today announced that patients with previously untreatedfollicular non-Hodgkin's lymphoma (NHL) treated with fludarabine andmitoxantrone, followed by administration of Zevalin(R) (Ibritumomab Tiuxetan),achieved 96 percent complete remission (CR), an estimated three-yearprogression-free survival (PFS) rate of 76 percent, and a 100 percentestimated three-year overall survival (OS) rate. The side effects weregenerally mild without any signs of cumulative toxicity, and hematologicalside effects were moderate. Results of the study were reported in the onlineedition of The Lancet (Lancet Oncology, DOI:10.1016/S1470-2045(08)70039-1).CTI acquired the U.S. rights to Zevalin in December, 2007.

The objective of the study was to determine the tolerability and efficacyof Zevalin consolidation following sequential fludarabine and mitoxantronetherapy without rituximab in first-line treatment of follicular NHL.

"This study underscores the potential use of radioimmunotherapy withZevalin to convert the majority of partial remissions to complete remissionsand to induce molecular remissions after conventional chemotherapy, both ofwhich correlate with durable progression-free survival rates," noted Jack W.Singer, M.D., Chief Medical Officer at CTI.

A total of 61 patients with advanced (stage III-IV) follicular NHL weretreated with six cycles of fludarabine and mitoxantrone chemotherapy; 57patients (43 with CR and 14 with PR) were subsequently treated with Zevalintherapy. Consolidation with Zevalin converted 12 of 14 partial remissions (86percent) to complete remissions for a complete response rate of 96 percent.With a median follow-up of 30 months, estimated three-year progression-freesurvival (PFS) was 76 percent and estimated three-year overall survival 100percent. Twenty two percent of patients tested (5 of 23) achieved a molecularremission following chemotherapy. Zevalin consolidation induced a molecularremission in 14 of 18 patients (78 percent) tested who did not achieve amolecular remission after fludarabine-mitoxantrone therapy. Grade 3/4thrombocytopenia, neutropenia, and anemia occurred in 63 percent (36 of 57),53 percent (30 of 57), and 23 percent (13 of 57), respectively. Febrileneutropenia occurred in 9 percent (5 of 57) of patients. Patients who relapsedwere treated with CHOP + rituximab as salvage therapy and all tolerated sixcycles of therapy indicating that treatment with Zevalin did not preclude theability to administer an aggressive salvage regimen.

Details of the Study

The phase II trial, reported by P.L. Zinzani et. al. from the Institute ofHematology and Medical Oncology at the University of Bologna in Bologna Italy,was a prospective, single-arm, open-label, multi-center, non-randomized trial,known as FLUMIZ (FLUdarabine, MItoxantrone, Zevalin). The trial was conductedat 13 Italian institutions to evaluate the efficacy and safety of this regimenas first-line therapy in untreated patients with follicular non-Hodgkin'slymphoma. Patients with stage III or IV untreated indolent follicular NHL weretreated with oral fludarabine and intravenous mitoxantrone every 28 days forsix cycles. Patients who had at least a partial response with adequateplatelet counts (>100x10^9/L) and granulocyte counts (1.5x10^9/L), and bonemarrow tumor infiltration of less than 25 percent four to six weeks aftercompletion of the sixth cycle of chemotherapy were deemed eligible forconsolidation treatment six to ten weeks after the sixth cycle with one courseof Zevalin. Primary endpoints were complete response and hematological toxiceffects and secondary endpoints were overall survival and progression-freesurvival.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy calledradioimmunotherapy and is indicated for the treatment of patients withrelapsed

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