ASH Clinical News ACN_4.11_Full Issue_web | Page 13

For the latest news in hematology, visit ASHClinicalNews.org! CMYK See Final OS Data Analysis WH E N M U LTI P L E M YE LOM A RE LA PSE S , Don’t put your patient’s survival at risk KYPROLIS ® -based regimens (KRd and Kd) reduced the risk of death by 21% vs Rd and Vd and extended median overall survival by 7.9 and 7.6 months, respectively 1, * ,†,‡,§ KRd Kd AS A TRIPLET THERAPY 8.7-month increase in median PFS 1 9.3-month increase in median PFS 1 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 7.9-month increase in median OS 1 * 48.3 months (KRd) vs 40.4 months (Rd); hazard ratio (KRd/Rd) = 0.79 (95% CI: 0.67-0.95); two-sided P = 0.0091 >3x CR or better 1 32% (KRd) vs 9% (Rd) KRd vs Rd Phase 3 design: N = 792, randomized (1:1), open-label superiority study comparing KRd vs Rd in relapsed or refractory multiple myeloma patients who had received 1 to 3 lines of therapy. The primary endpoint was progression-free survival. Select secondary endpoints included overall survival and overall response rate. KYPROLIS ® was discontinued per protocol in the KRd arm after 18 cycles of treatment. 1,2 † AS A DOUBLET THERAPY 18.7 months (Kd) vs 9.4 months (Vd); hazard ratio (Kd/Vd) = 0.53 (95% CI: 0.44-0.65); one-sided P < 0.0001 ‡ § 7.6-month increase in median OS 1 47.6 months (Kd) vs 40.0 months (Vd); hazard ratio (Kd/Vd) = 0.79 (95% CI: 0.65-0.96); one-sided P = 0.01 Kd vs Vd Phase 3 design: N = 929, randomized (1:1), open-label superiority study comparing Kd to Vd in relapsed or refractory multiple myeloma patients who had received 1 to 3 lines of therapy. The primary endpoint was progression-free survival. Overall survival was a prespecifi ed key secondary effi cacy endpoint. 1,3 See more OS results at KYPROLIS-HCP.com CI = confi dence interval; CR = complete response; Kd = KYPROLIS ® and dexamethasone; KRd = KYPROLIS ® , lenalidomide, and dexamethasone; OS = overall survival; PFS = progression-free survival; Rd = lenalidomide and dexamethasone; Vd = VELCADE ® (bortezomib) and dexamethasone. IMPORTANT SAFETY INFORMATION FOR KYPROLIS Cardiac Toxicities: New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration. Please see additional Important Safety Information on left. References: 1. KYPROLIS ® (carfi lzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Siegel DS, Dimopoulos MA, L