KYPROLIS (carfilzomib) for Injection Menu

7.6-month increase in median OS1

*47.6 months (Kd) vs 40.0 months (Vd); hazard ratio (Kd/Vd) = 0.791 (95% CI: 0.648-0.964); one-sided P = 0.01

9.3-month increase in median PFS2

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

CI = confidence interval; Kd = KYPROLIS® (carfilzomib) 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.

K + d SEE Kd RESULTS

Kd vs Vd study: A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to VELCADE® plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized to a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either VELCADE® or KYPROLIS®, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of VELCADE® administration, if randomized to the VELCADE® group (intravenous vs subcutaneous). The primary endpoint was progression-free survival (PFS). Select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety. The significance level of the pre-planned 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.1-4

Adding KYPROLIS® to Rd TRIPLES your patient’s chance of achieving CR or better as observed in the KRd vs Rd study2,‡

>3x CR or better2

32% (KRd) vs 9% (Rd)

8.7-month increase in median PFS2

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

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

K + d SEE KRd RESULTS

KRd vs Rd study: A phase 3, randomized, open-label, multicenter superiority study evaluated KYPROLIS® in combination with lenalidomide and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. 792 patients were randomized in a 1:1 ratio (396 patients to KRd, 396 to Rd). Patients received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity occurred. KYPROLIS® was discontinued after Cycle 18. The primary endpoint was progression-free survival (PFS); select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety.2,5

KYPROLIS® dosing:
Add K to d or Add K to Rd

Kd 56 mg/m2 therapeutic dose
KRd 27 mg/m2 therapeutic dose
See KYPROLIS® Dosing

d = dexamethasone; K = KYPROLIS®;
Rd = lenalidomide and dexamethasone.

Safety profile

of KYPROLIS® regimens
(Kd and KRd) and treatment duration

SEE SAFETY PROFILE

Amgen Assist 360™:

Here to help your patients

Amgen Assist 360<sup>TM</sup> logo SEE SUPPORT

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. 5. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142-152. 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.
VELCADE® is a registered trademark of Millennium Pharmaceuticals, Inc.

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