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Celgene Announces Results of Two Studies Evaluating Combo of Revlimid, Rituximab

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Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that results from two studies evaluating the combination of REVLIMID^® (lenalidomide) and rituximab in various non-Hodgkin's lymphomas were presented at the 12th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.

“The increasing volume of clinical evidence evaluating combinations utilizing REVLIMID plus rituximab provide us powerful insight into the potential of antibody-dependent cellular cytotoxicity in lymphomas, and the potential of these novel combinations in patients in subtypes with a poor prognosis,” said Jean-Pierre Bizzari, M.D., Executive Vice President, Hematology and Oncology for Celgene Corporation. “We look forward with great interest to further data from the studies presented at this year's ICML conference.”

Lenalidomide plus rituximab in patients with previously untreated follicular lymphoma

In this preliminary report from a phase II study, conducted by the Alliance for Clinical Trials in Oncology, and presented by Peter Martin, M.D., Assistant Professor of Medicine at Weill Cornell Medical College, patients with untreated follicular lymphoma, including those with grade 1-3a, stage 3-4 or bulky stage 2 and FLIPI 0-2 disease, were given lenalidomide (20mg/day on days 1-21 of each 28-day cycle) for 12 cycles and rituximab (four weekly doses of 375 mg/m2 during cycle 1 and on day 1 of cycles 4,6,8 and 10). Sixty-six patients were initially enrolled. The primary outcomes were response rate and progression-free survival (PFS).

Of 54 patients evaluable for response, the overall response rate was 92.6% (50/54), including 72.2% (39/54) of patients who achieved a complete response, 20.4% (11/54) who achieved a partial response, 3.7% (2/54) who achieved stable disease and 3.7% who (2/54) did not respond.

In the study, the most common grade 3-4 adverse events that occurred in at least 5% of patients included neutropenia (20%), lymphopenia (8%), rash (8%), fatigue (6%), and leukopenia (5%).

Combination of Lenalidomide with R-CHOP (R2CHOP) in DLBCL

Another phase II study, presented by Grzegorz Nowakowski, M.D., Assistant Professor of Medicine at the Mayo Clinic, evaluated the combination of lenalidomide plus rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin and prednisone (R2CHOP) in patients with newly diagnosed diffuse large b-cell lymphoma (DLBCL) or grade 3b follicular lymphoma.

In this study, 63 patients with DLBCL and four patients with grade 3b follicular lymphoma received six cycles of R2CHOP and were assessed for response using PET/CT at the end of the course of therapy. Primary outcomes were response rate and PFS.

In the 63 patients evaluable for response, the overall response rate was 98%, with 74% of patients achieving a complete response. At 18 months, the PFS rate for these patients was 66% (95% CI: 55-80%).

The most common grade 3 and 4 hematological adverse events in the study were thrombocytopenia (21% and 18%, respectively) and neutropenia (15% and 73). The most frequent non-hematologic toxicities were febrile neutropenia (8%) and fatigue (5%). There was one death (2%) due to bowel perforation.

An additional PFS analysis was conducted, comparing the results in the study cohort with 87 consecutive DLBCL patients in a Mayo Clinic Database treated with standard RCHOP. Each cohort included both patients with and without germinal center b-cell (GCB) subtypes.

The PFS at 18 months for all patients in the RCHOP cohort was 57% (95% CI: 48-69%). The non-GCB patients treated with RCHOP had a significantly worse PFS when compared with GCB patients, with 18-month PFS rates of 32% (95% CI: 19-55%) and 70% (95% CI: 59-82%), respectively, (p=0.002). For patients treated with R2CHOP, non-GCB patients had an 18-month PFS rate of 73% (95% CI: 55-97%), which was not significantly different than the 18-month PFS rate of 55% (95% CI: 37-83%) in GCB patients, (p=0.78).

These data are from investigational studies. REVLIMID^® and REVLIMID plus rituximab are not approved for the treatment of follicular lymphoma or DLBCL.

Posted-In: News FDA

 

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