Loading...
Loading...
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation
, today announced data from a study comparing melphalan,
prednisone and REVLIMID (lenalidomide) (MPR) with high-dose chemotherapy and
tandem autologous stem cell transplant (MEL200), as well as evaluating the
effect of lenalidomide maintenance in patients with newly-diagnosed multiple
myeloma were presented during a June 3^rd oral session at the American Society
of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago, Ill.
In the study, conducted by the Gruppo Italiano Malattie EMatologiche
dell'Adulto (GIMEMA), and presented by lead investigator, Prof. Antonio
Palumbo, Chief of the Myeloma Unit, Department of Oncology, at the University
of Torino, a total of 402 patients received four 28-day courses of
lenalidomide and low-dose dexamethasone at diagnosis, and then were randomly
assigned to receive six cycles of MPR (n=202) or MEL200 (n=200), and to
receive either continuous lenalidomide maintenance treatment or to be followed
by observation.
After a median follow-up of 49 months from diagnosis, median progression-free
survival (PFS), the primary endpoint of the study, was 24 months with MPR
compared to 38 months with MEL200 (HR 1.69, p<0.0001). ). The five-year
overall survival (OS) rate was 62% (125/202) for MPR compared to 71% (142/200)
for MEL200 (HR 1.25, p=0.27).
In the maintenance analysis, with a median follow-up of 35 months, patients
receiving lenalidomide maintenance following either regimen, had a median PFS
of 37 months compared to 26 months for observation (HR 0.52, p<0.0001). In
addition, for patients receiving lenalidomide maintenance, the five-year OS
rate was 75% (149/198) compared to 58% (118/204) for patients being observed
until disease progression (HR 0.62, p=0.02) equating to a 38% reduction in the
risk of death for patients receiving continuous lenalidomide maintenance
therapy.
The most common grade 3/4 adverse events observed during the maintenance phase
of the study were neutropenia (23%), cutaneous toxicity (5%), infections (4%),
second primary malignancies (4%), thrombocytopenia (4%), diarrhea (3%),
fatigue (3%) and anemia (2%).
These results are from an investigational study. REVLIMID^® is not approved
for the treatment of patients with newly-diagnosed multiple myeloma.
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in