REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

Celgene International Sàrl (NASDAQ: CELG) announced that clinical data from two studies evaluating the use of REVLIMID^® (lenalidomide) with standard R-CHOP chemotherapy (R²CHOP) in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11^th International Conference on Malignant Lymphoma in Lugano, Switzerland.

In a phase I/II study conducted by investigators at the Mayo Clinic, 12 patients received REVLIMID at doses of 15 mg, 20 mg or 25 mg on days 1-10 of each 21-day cycle with standard R-CHOP chemotherapy to determine the maximum tolerated dose (MTD) of REVLIMID. There were no dose-limiting toxicities observed.

In the phase II portion, 32 evaluable patients received 25 mg of REVLIMID on days 1-10 administered with standard R-CHOP chemotherapy (R²CHOP) for up to six cycles. Twenty-eight patients had DLBCL and four patients had grade 3 follicular lymphoma. The age range was 19 to 87 years.

Responses were evaluated using PET/CT. Out of 30 evaluable patients, the overall response rate was 100% and the complete response rate was 83%.

The most common hematological toxicities were grade 3/4 thrombocytopenia (16%/25%) and grade 3/4 neutropenia (13%/75%).

In a similarly designed phase I study conducted by the Fondazione Italiana Linfomi (FIL) in elderly patients with untreated DLBCL, REVLIMID was combined with R-CHOP (LR-CHOP21). Twenty-one patients received REVLIMID at doses of 10 mg, 15 mg, or 20 mg on days 1-14 of each 21-day cycle with standard R-CHOP chemotherapy to determine the maximum tolerated dose (MTD) of REVLIMID^®. With this particular schedule, REVLIMID at a dose of 15mg was determined to be the MTD. The age range was 61 to 77 years.

Response was evaluated using PET/CT, and of 21 evaluable patients, the overall response rate was 86% and the complete response rate was 76% after 6-cycles of LR-CHOP21.

The most common grade 3 or higher hematological toxicities were neutropenia (28%) and thrombocytopenia (10%), and the most common non-hematologic toxicities greater grade 3 or higher were neuropathy (14%) and infections (14%).

These data are from an investigational study. REVLIMID is not approved as a treatment for patients with DLBCL or follicular grade III lymphoma.