KYPROLIS (carfilzomib) for Injection Menu

Don’t put your patient’s survival at risk. In a superiority study, KRd reduced the risk of death by 21% compared to Rd.1,*

Primary Endpoint: PFS

7.9-month increase in median OS1*48.3 months (KRd) vs 40.4 months (Rd); hazard ratio (KRd/Rd) = 0.79 (95% CI: 0.67-0.95)

Primary Endpoint: PFS

8.7-month increase in median PFS226.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001

Primary Endpoint: PFS

>3x CR or better232% (KRd) vs 9% (Rd)

CI = confidence interval; CR = complete response; KRd = KYPROLIS®, lenalidomide, and dexamethasone; OS = overall survival; PFS = progression-free survival; Rd = lenalidomide and dexamethasone.

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

Progression-free survival (PFS)

8.7-month increase in median PFS shown with KRd vs Rd2

Primary endpoint: PFS2
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 lenalidomide3

CI = confidence interval; HR = hazard ratio

Overall survival (OS)

In a superiority study, KRd reduced the risk of death by 21% and increased median overall survival by 7.9 months compared to Rd1

Secondary endpoint: OS1
See the KRd vs Rd study OS chart
  • Median OS

  • KRd = 48.3 months
  • Rd = 40.4 months
  • HR (KRd/Rd) = 0.79 (95% CI: 0.67-0.95)

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. Per protocol, patients received 18 cycles of KYPROLIS® with Rd and then continued treatment with Rd alone to progression.4

The KRd vs Rd 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

KRd patients achieved a deeper response vs Rd patients2

Secondary endpoint: patient response, by category (%)2
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 patients2

Median duration of response2
See median duration of response in the KRd vs Rd study

CI = confidence interval.

References

1. Data on file, Amgen; [1]; 2017. 2. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 3. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142-152. 4. Data on file, Amgen; [2]; 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