5.7-year median PFS with
REVLIMID Maintenance 2
CALGB (STUDY 1): 3.8-YEAR INCREASE IN MEDIAN PFS VS PLACEBO †
1.0
REVLIMID (n=231)
HR 0.38 (95% CI 0.28, 0.50)
Placebo (n=229)
0.8
5.7 years
0.6
(95% CI 4.4, NE)
0.4
1.9 years
0.2
(95% CI 1.6, 2.5)
0.0
0
1
2
3
4
5
6
7
8 9
5
0 0
Progression-free survival (years)
Number of Subjects at Risk
REVLIMID
Placebo
231
229
194
116
158
57
121
29
102
20
82
18
40
11
16
3
CALGB PFS Events: REVLIMID = 97/231 (42%), Placebo = 116/229 (51%)
IFM PFS Events: REVLIMID = 191/307 (62%), Placebo = 248/307 (81%)
IFM (Study 2): 1.9-year advantage
in median PFS vs placebo ‡
• Median PFS: 3.9 years with REVLIMID Maintenance (95% CI 3.3, 4.7) (n=307) vs 2.0 years with placebo
(95% CI 1.8, 2.3) (n=307) (HR 0.53 [95% CI 0.44, 0.64])
Trial Design: CALGB (Study 1) and IFM (Study 2) were multicenter, randomized, double-blind, parallel-group, placebo-controlled
studies in newly diagnosed patients 18-70 years (CALGB) and <65 years at diagnosis (IFM) who received auto-HSCT following
induction therapy, which must have occurred within 12 months. Patients were randomized 1:1 to receive REVLIMID or placebo
maintenance 90-100 days (CALGB) or within 6 months (IFM) post auto-HSCT. Patients were required to achieve at least stable
disease following hematologic recovery and CrCl ≥30 mL/min. The primary endpoint for both studies was PFS, based on assessment
by investigator, and was defi ned from randomization to the date of progression or death, whichever occurred fi rst. In both studies,
the starting dose of REVLIMID was 10 mg once daily for repeated 28-day cycles. If tolerated after 3 months, a dose increase to
15 mg once daily occurred in 135 patients (58%) in CALGB, and 185 patients (60%) in IFM. The dose was reduced, interrupted,
and/or discontinued as needed to manage toxicity. Patients were treated until disease progression, unacceptable toxicity, or patient
withdrawal for any reason. At a preplanned interim analysis, the primary endpoint of PFS was met and both studies were unblinded
and patients continued to be followed as before. Patients in the placebo arm of CALGB were allowed to cross over to receive
REVLIMID before disease progression; patients in the IFM study were not recommended to
cross over. In IFM, REVLIMID was stopped at the recommendation of the Data Monitoring
Committee in January 2011.
Please see Important Safety Information and Brief Summary,
including Boxed WARNINGS, on the following pages.