Two Studies Demonstrate REVLIMID(R) (lenalidomide) Activity in Patients with Relapsed/Refractory Aggressive Non-Hodgkin´s Lymphoma
Celgene International Sarl (NASDAQ: CELG) announced that clinical
data from two ongoing REVLIMID studies in Relapsed/Refractory
Aggressive Non-Hodgkins Lymphoma (NHL) were reported during the 49th
Annual Meeting of the American Society of Hematology (ASH). These
studies demonstrate REVLIMID´s activity in NHL and the need to further
evaluate treatment in this critical area of blood disease.
NHL is the most common form of blood cancer in the United States
affecting nearly 500,000 people. Approximately 50% have aggressive
NHL, while the other half have indolent or follicular lymphoma.
According to the Leukemia & Lymphoma Society, more than 63,000 men and
women in the United States are diagnosed with NHL each year.
The initial analysis of the first 46 patients of a 200 patient
phase-II, multi-center open-label clinical study, NHL-003, shows
encouraging results that are consistent with those of the earlier
NHL-002 trial (Abstract #2565). Responses were seen across all
sub-types of NHL. Furthermore, prognostic factors have been identified
that may be predictive of response to REVLIMID monotherapy. The study
reported that overall response to single agent lenalidomide was 28%,
with 6 responses in the diffuse large B-cell lymphoma group (21%) and
5 in the mantle cell lymphoma group (38%). Ten patients had stable
disease (SD), for a tumor control rate (CR, unconfirmed CR, PR or SD)
of 50%.
"The data from these studies are encouraging in that they show an
impressive response to REVLIMID in relapsed/refractory, aggressive
NHL," said John Leonard, M.D., The Richard T. Silver Distinguished
Professor of Hematology Medical Oncology at Weill Cornell Medical
College. "These data justify a wide exploration of REVLIMID in a
variety of lymphoma settings both alone and in combination, and
warrant a detailed assessment of which patients can particularly
benefit."
This data validated NHL-002, which showed that tumor burden and
time from last dose of rituxumab were demonstrated to be highly
significant predictive factors for response of aggressive NHL to
lenalidomide monotherapy. Although, ALC did not reach significance, a
trend was evident. Analysis of the individual prognostic factors for
response in the NHL-003 study indicated a trend for all 3 factors:
-- Low disease burden as estimated by the sum of all
bi-dimensionally measured disease (33% for less than 50 cm2
versus 17% for => 50 cm2)
-- Longer time from last rituximab dose to lenalidomide treatment
(44% for => 230 days versus 5% for less than 230 days)
-- Higher ALC (34% for greater than 0.6 x 109/L versus 10% for