Celgene International Sàrl (NASDAQ: CELG) announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID (lenalidomide) plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.
Patients entering the study included 45 with follicular lymphoma (FL), 24 with marginal zone lymphoma and 24 with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The age range was 35 to 84. Patients in the study received 20 mg/day of REVLIMID on days one to 21, and 375mg/m2 of rituximab on day one of each 28 day cycle for six cycles. The study has been amended to allow patients deriving clinical benefit to remain on study for up to 12 cycles. Of the 93 patients who could be evaluated for a response, the overall response rate (ORR) was 91% and the complete response rate (CR) was 65%. Additionally, the 24-month progression-free survival rate was 86%.
Looking specifically at the follicular lymphoma patients, 85% (38/44) evaluable FL patients achieved a complete response. When categorized by the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria, CR and unconfirmed CR rates (Cru) were 95% in patients who met the GELF criteria for treatment, and 78% in patients who did not. After six cycles nearly all FL patients demonstrated a molecular response (BCL-2 proto-oncogene translocation not detectable by PCR).
Four patients experienced disease progression at a median follow-up of 14.4 months. For the total study population, the most common grade 3 non-hematological toxicities included eight cases with rash (9%), seven cases of muscle pain (8%), and three cases each of thrombosis and infection (3% each). Grade 3 neutropenia occurred in 25 patients (27%) and there were four cases of grade 3 thrombocytopenia (4%). Five patients (5%) stopped treatment due to adverse events, all within the first two cycles of treatment.
The results of this study have encouraged plans for a multi-national, phase III trial investigating the R2 combination compared to standard chemoimmunotherapy regimens in newly diagnosed FL (the RELEVANCE trial). This trial is designed to validate the concept of using REVLIMID to enhance ADCC (antibody-dependent cell-mediated cytotoxicity) in patients being treated with rituximab.
Celgene International Sàrl