KYPROLIS (carfilzomib) for Injection Menu

Don't put your patient's survival at risk.
In a head-to-head study, Kd reduced the risk of death by 21% compared to Vd1,*

7.6-month increase in median OS1 *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

9.3-month increase in median PFS218.7 months (Kd) vs 9.4 months (Vd); hazard ratio (Kd/Vd) = 0.53 (95% CI: 0.44-0.65); one-sided P  <  0.0001

CI = confidence interval; Kd = KYPROLIS® and dexamethasone; OS = overall survival; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

The Kd vs Vd OS results have not yet been reviewed by FDA, and inclusion in the final, FDA-approved label for KYPROLIS® has yet to be determined.

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Progression-free survival (PFS)

9.3-month increase in median PFS demonstrated with KYPROLIS® regimen vs VELCADE® regimen (Kd vs Vd)2

Primary endpoint: PFS2
See the Kd vs Vd study PFS chart
  • Median PFS

  • Kd = 18.7 months
  • Vd = 9.4 months
  • HR (Kd/Vd) = 0.53 (95% CI: 0.44-0.65)
  • One-sided P < 0.0001

The difference in PFS was consistently observed regardless of prior proteasome inhibitor exposure (exploratory subgroup analysis)3

Exploratory subgroup analysis

This study was not powered for PFS efficacy in these subgroups, and estimation of PFS efficacy was not a study objective.

VELCADE® naive3
See the Kd vs Vd study PFS chart for VELCADE<sup>®</sup>-naive patients
Prior VELCADE® exposure3
See the Kd vs Vd study PFS chart for patients with prior VELCADE<sup>®</sup> exposure

CI = confidence interval; HR = hazard ratio.

Overall survival (OS)

In a head-to-head study, Kd reduced the risk of death by 21% and increased median overall survival by 7.6 months compared to Vd1,*

Secondary endpoint: OS4
See the Kd vs Vd study OS chart
  • Median OS

  • Kd = 47.6 months
  • Vd = 40.0 months
  • HR (Kd/Vd) = 0.79 (95% CI: 0.65-0.96)
  • One-sided P = 0.01

OS was a prespecified key secondary efficacy endpoint. The significance level of the preplanned OS second interim analysis is determined by the O'Brien-Fleming type alpha spending function based on the number of OS events observed by the analysis time.4

The Kd vs Vd OS results have not yet been reviewed by FDA, and inclusion in the final, FDA-approved label for KYPROLIS® has yet to be determined.

CI = confidence interval; HR = hazard ratio

Response depth/duration

Kd patients achieved a deeper response vs Vd patients2

Secondary endpoint: patient response by category (%)2
See depth of response achieved in the Kd vs Vd study

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

Among patients who achieved a response, Kd patients experienced a > 10-month increase in the median duration of response compared to Vd patients2

Median duration of response2
See median duration of response in the Kd vs Vd study

CI = confidence interval; NE = not estimable.

References

1. Dimopoulos MA, Goldschmidt H, Niesvizky R, et al. Overall survival of patients with relapsed or refractory multiple myeloma treated with carfilzomib and dexamethasone versus bortezomib and dexamethasone in the randomized phase 3 ENDEAVOR trial. Abstract presented at: 16th International Myeloma Workshop; March 1-4, 2017; New Delhi, India. Abstract. 2. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 3. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17(1):27-38. 4. Data on file, Amgen; 2017.

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)

Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

Embryo-fetal Toxicity

Adverse reactions

Please see full Prescribing Information.

Indications