Celgene Corporation (NASDAQ:CELG) today announced that results of a study evaluating the combination of REVLIMID® (lenalidomide) with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in untreated diffuse large b-cell lymphoma (DLBCL) were published online ahead of print in the Journal of Clinical Oncology.
In a phase II, open label, single arm study, by Dr. Grzegorz Nowakowski of the Mayo Clinic, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival (EFS) with secondary endpoints of progression free survival (PFS) and overall survival (OS). A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP.
Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response (OR) rate was 98% (59/60) with 80% (48/60) achieving a complete response (CR). The 24-month EFS, which was identical to PFS, and OS rates were 59% (48-74%) and 78% (68-90%), respectively (95% CI).
DLBCL molecular sub-type was determined by tumor immunohistochemistry (Hans algorithm) and classified as germinal center B-cell (GCB) vs. non-GCB. Additionally, 87 consecutive control patients from the Mayo Clinic Lymphoma Database who received conventional R-CHOP and who met the same inclusion criteria as R2CHOP treated patients were identified and analyzed for outcome based on DLBCL sub-types.In the R-CHOP patients, 24-month progression-free survival (PFS) and OS were 28% vs. 64%, p<0.001 and 46% vs. 78%, p<0.001 in non-GCB patients vs. GCB patients, respectively. In patients treated with R2CHOP, the 24-month PFS and OS rates were 60% vs. 59%, p=0.83 and 83% vs. 75%, p=0.61 in non-GCB patients vs. GCB patients, respectively.