KYPROLIS (carfilzomib) for Injection Menu

Adding KYPROLIS® to Rd TRIPLES your patient’s chance of achieving a complete response (CR) or better as observed in the KRd vs Rd study1,*

Primary Endpoint: PFS

>3x CR or better*32% (KRd) vs 9% (Rd)1

Primary Endpoint: PFS

~9-month increase in median PFS26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.00011

CR = complete response; KRd = KYPROLIS®, lenalidomide, and dexamethasone;
PFS = progression-free survival; Rd = lenalidomide and dexamethasone.

Progression-free survival (PFS)

1.5x median PFS shown with KRd vs Rd1

Primary endpoint: PFS1
See the KRd vs Rd study PFS chart
  • Median PFS

  • KRd = 26.3 months
  • Rd = 17.6 months
  • HR = 0.69 (95% CI: 0.57-0.83)
  • 2-sided P = 0.0001
  • Patients received KYPROLIS® through Cycle 18.
  • PFS benefit of KRd was consistently seen across all prespecified patient subgroups, including age, cytogenetic risk, prior bortezomib, and prior lenalidomide2
Response depth/duration

KRd patients achieved a deeper response vs Rd1

Secondary endpoint: patient response, by category (%)1
See depth of response achieved in the KRd vs Rd study

CR = complete response; ORR = overall response rate; PR = partial response; sCR = stringent complete response; VGPR = very good partial response.

Among patients that achieved a response, KRd patients experienced a  > 7-month increase in the median duration of response than Rd patients1

Median duration of response1
See median duration of response in the KRd vs Rd study

CI = confidence interval.

Overall survival (OS)

Overall survival (OS) results were not significantly different at the interim analysis1

Secondary endpoint: interim OS analysis1
See overall survival in the KRd vs Rd study
  • Deaths, n (%)

  • KRd = 143 (36.1)
  • Rd = 162 (40.9)
  • Median OS, months

  • KRd = NE
  • Rd = NE
  • Note: The interim OS analysis did not meet the protocol-specified early stopping boundary for OS.

NE = non-estimable.

References

1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142-152.

Important Safety Information

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 KYPROLIS administration.
  • Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart KYPROLIS at 1 dose level reduction based on a benefit/risk assessment.
  • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure.
  • Patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment (including blood pressure and fluid management) prior to starting treatment with KYPROLIS and remain under close follow-up.

Acute Renal Failure

Tumor Lysis Syndrome

Pulmonary Toxicity

Pulmonary Hypertension

Dyspnea

Hypertension

Venous Thrombosis

Infusion Reactions

Hemorrhage

Thrombocytopenia

Hepatic Toxicity and Hepatic Failure

Thrombotic Microangiopathy

Posterior Reversible Encephalopathy Syndrome (PRES)

Embryo-fetal Toxicity

Adverse reactions

Please see full Prescribing Information.

Indications