ASH Clinical News December 2015 | Page 49

Median Progression-Free Survival (PFS) Rd Continuous (n=535) 25.5 mo (95% CI 20.7, 29.4) Rd18 (n=541) 20.7 mo (95% CI 19.4, 22.0) MPT (n=547) 21.2 mo (95% CI 19.3, 23.2) 100 Survival Probability (%) 80 Rd Continuous vs MPT Rd Continuous vs Rd18 Rd18 vs MPT 60 HR (95% CI) Logrank P value (2-sided) 0.72 (0.61, 0.85) P<0.0001 0.70 (0.60, 0.82) 1.03 (0.89, 1.20) Planned duration of treatment in the Rd18 40 and MPT arms was 18 months 20 0 0 1 2 3 4 5 Progression-Free Survival (Years) •535 PFS Rd Continuous Rd18 541 MPT MM-020 547 Study design: The Events: (52.0%), (64.3%), MPT=334/547 400Rd Continuous=278/535 319 265 218 Rd18=348/541 168 105 55 19 (61.1%)2 391 380 (FIRST) 319 265 167 304 244 compared REVLIMID170+ 108 116 low-dose 56 30 58 28 (Rd) dexamethasone 7 2 6 1 Continuous until 0 0 0 progression, trial fixed-cycle MPT, and fixed-cycle Rd18. MM-020 was a Phase 3, randomized, multicenter, open-label, 3-arm study enrolling 1623 newly diagnosed Number of Subjects at mg Risk patients who did not receive a stem cell transplant (SCT). REVLIMID was given 25 once daily orally on Days 1 to 21 of 28-day cycles, PFS Events: Rd Continuous=278/535 (64.3%), (61.1%) ≤75 years and 20 mg for patients and dex was dosed once daily orally on Days 1, 8, 15,(52.0%), and 22Rd18=348/541 of each 28-day cycleMPT=334/547 (40 mg for patients >75 years). The primary endpoint in the trial was progression-free survival (PFS), as the time from randomization to the first documentation of disease progression as determined by Independent Response Adjudication Committee (IRAC), based on International Myeloma Working Group (IMWG) criteria, or death due to a