Clinical Data Evaluating Oral REVLIMID® Either with Rituximab or Following Rituximab Combination for Patients with Chronic Lymphocytic Leukemia (CLL) Presented at ASH

[Guest guest]

BlankDecember 04, 2010 05:53 PM Eastern Time

Clinical Data Evaluating Oral REVLIMID® Either with Rituximab or Following

Rituximab Combination for Patients with Chronic Lymphocytic Leukemia (CLL)

Presented at ASH

Study Evaluating REVLIMID as Consolidation Therapy in Patients with Previously

Untreated CLL Reported 91% of Patients Were Still Alive After a Median Follow-Up

of 21 Months

Second Study Evaluating Combination of REVLIMID and Rituximab in Patients with

Relapsed/Refractory CLL Reported an Overall Response Rate of 63%

BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl (NASDAQ: CELG)

announced that clinical data from two investigational studies evaluating the use

of REVLIMID® (lenalidomide) either with rituximab or following a

rituximab-containing regimen in patients with chronic lymphocytic leukaemia

(CLL) were presented at the 52nd American Society of Hematology annual meeting.

In the first study, 38 of 44 patients with previously untreated CLL received six

cycles of pentostatin (2 mg/m2), cyclophosphamide (600 mg/m2) and rituximab (375

mg/m2) (PCR) every 21 days. Following this treatment regimen, 34 patients

continued to consolidation therapy with lenalidomide starting at 5 mg per day,

escalating to 10 mg per day as tolerated for a median of seven cycles.

At a median follow-up of 21 months, 91% (40/44) of patients were still alive,

and 21% (7/34) of patients who received at least one cycle of lenalidomide

consolidation showed an improvement in the quality of their response, including

three patients who converted from minimal residual disease (MRD)-positive to

MRD-negative disease. The median duration of response has not been reached.

Additionally, a comparison of these data against historic PCR data showed the

proportion of patients receiving consolidation who were free of retreatment at

12 months was 95% (42/44), compared to 86% (55/64) of patients without

lenalidomide consolidation in the historic study.

For patients receiving lenalidomide consolidation treatment in the study, the

most common grade 3 or higher adverse events were neutropenia (grade 3, 41%

14/38; grade 4, 21% 7/38), leukopenia (grade 3, 32% 11/38), platelet count

decrease (grade 3, 9% 3/38) and rash (grade 3, 6%, 2/38).

In the second study, 59 patients with relapsed/refractory CLL received rituximab

375 mg/m2 intravenously weekly for four weeks in cycle one, then once every four

weeks during cycles three through 12. Oral lenalidomide 10 mg/day was started on

day nine of cycle one on a continuous dosing schedule. Cycles were 28 days, with

intention to continue therapy for 12 cycles or longer if the patient achieved a

clinical response. Dose reductions were made following grade 3 or 4

lenalidomide-related adverse events, and allopurinol 300 mg daily was prescribed

during the first two weeks as tumour lysis syndrome prophylaxis.

All 59 patients were evaluable for response, with evaluations performed after

cycles three, six, and every six cycles thereafter. In the study, the overall

response rate was 63% (37/59), with 5% (3/59) achieving a complete response.

Additionally, 2% of patients (1/59) achieved a complete response with incomplete

haematological recovery. 14% of patients (8/59) achieved nodular partial

responses and 42% (25/59) achieved partial responses. Most responses (59%,

35/59) occurred within the first six cycles of therapy.

During the study, the highest incidences of grade 3/4 adverse events were

neutropenia (68%, 40/59), thrombocytopenia (22%, 13/59) and anaemia (10%, 6/59).

Grade 3/4 infections occurred in 18 patients (31%), mostly in the upper

respiratory tract. One patient experienced grade 3 tumour lysis syndrome. One

treatment-related death occurred during the study due to ischemic stroke with

infection.

These data are from an investigational study. Lenalidomide is not approved as a

treatment for patients with chronic lymphocytic leukaemia.