Indications
  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • KYPROLIS® is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
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FDA APPROVED
 KYPROLIS®+Darzalex® (daratumumab)+dexamethasone
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Kd vs Vd study design

The largest head-to-head superiority study comparing two proteasome inhibitors1

Phase 3, randomized, open-label study (N = 929) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy2

Phase 3, head-to-head superiority trial between 2 proteasome inhibitors1,2
Kd vs Vd: Head-to-head superiority study comparing two proteasome inhibitorsKd vs Vd: Head-to-head superiority study comparing two proteasome inhibitors

*Patient stratification included prior proteasome inhibitor therapy (either bortezomib or carfilzomib, 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 bortezomib administration, if randomized to the bortezomib group (intravenous vs subcutaneous).2

Inclusion criteria allowed for diverse patient types

Key inclusion criteria1,2
  • Relapsed or refractory multiple myeloma
  • 1 to 3 prior treatments
  • ECOG PS 0-2
  • Prior treatment with V or K was allowed if
    • ≥ PR to prior treatment
    • ≥ 6-month PI treatment-free interval
    • Not discontinued due to toxicity
  • LVEF ≥ 40%
  • Creatinine clearance ≥ 15 mL/min
Key exclusion criteria1,2
  • Grade 3 or 4 PN (or Grade 2 with pain) within 14 days prior to randomization
  • Myocardial infarction within 4 months prior to randomization
  • NYHA Class III or IV heart failure
  • < PR to all prior regimens

The patients studied in the Kd vs Vd trial may resemble the patients in your practice

ECOG PS = Eastern Cooperative Oncology Group Performance Status; IV = intravenous; K = KYPROLIS® (carfilzomib); Kd = KYPROLIS® (carfilzomib) and dexamethasone; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association; PI = proteasome inhibitor; PN = peripheral neuropathy; PO = per os (by mouth); PR = partial response; RRMM = relapsed or refractory multiple myeloma; SC = subcutaneous; V = VELCADE® (bortezomib); Vd = VELCADE® (bortezomib) and dexamethasone.

Select patient demographics and baseline characteristics1,2

Characteristic Kd (n = 464) Vd (n = 465)
Age
Median, years (range) 65 (35-89) 65 (30-88)
≥ 75 years, n (%) 77 (17) 66 (14)
ECOG Performance Status, n (%)
0 221 (48) 232 (50)
1 210 (45) 203 (44)
2 33 (7) 30 (6)
ISS stage, n (%)
I 219 (47) 212 (46)
II 138 (30) 153 (33)
III 107 (23) 100 (22)
Cytogenetic risk category by FISH, n (%)
High 97 (21) 113 (24)
Standard 284 (61) 291 (63)
Unknown* 83 (18) 61 (13)
Creatinine clearance, n (%)
< 30 mL/min 28 (6) 28 (6)
30 to < 50 mL/min 57 (12) 71 (15)
50 to < 80 mL/min 186 (40) 177 (38)
≥ 80 mL/min 193 (42) 189 (41)
Baseline neuropathy, n (%)
Grade 1 133 (29) 159 (34)
Grade 2 10 (2) 10 (2)

*Missing FISH data are included with the unknown risk (Kd = 28 [6.0%], Vd = 31 [7.0%]).1

Prior regimens at baseline2

Prior regimens at baseline Kd (n = 464) Vd (n = 465)
Number of prior regimens, median (range) 2 (1-3) 2 (1-3)†
Prior regimens, n (%)
1 232 (50) 231 (50)
2 158 (34) 144 (31)
3 74 (16) 88 (19)
Prior therapies, n (%)
Bortezomib 250 (54) 252 (54)
Stem cell transplant 266 (57) 272 (59)
Thalidomide 212 (46) 249 (54)
Lenalidomide 177 (38) 178 (38)
Bortezomib plus immunomodulatory agent 159 (34) 168 (36)
Refractory to last prior therapy, n (%) 184 (40) 189 (41)

Note: Refractory was defined as disease not achieving a minimal response or better, progressing during therapy, or progressing within 60 days after completion of therapy.2

†Two patients in the Vd arm had 4 prior regimens.2

ECOG = Eastern Cooperative Oncology Group; FISH = fluorescence in situ hybridization; ISS = International Staging System; Kd = KYPROLIS® (carfilzomib) and dexamethasone; Vd = VELCADE® (bortezomib) and dexamethasone.

See Kd vs Vd safetySee Kd vs Vd safety
Next Kd vs Vd study results
REFERENCES

1. 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;17:27-38. 2. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary.

VELCADE® (bortezomib) is a product of Millennium Pharmaceuticals.

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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), 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.
  • Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse reactions until recovery, and consider whether to restart 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.
  • For 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 prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.

Acute Renal Failure

  • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

Tumor Lysis Syndrome

  • Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.

Pulmonary Toxicity

  • Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS.

Pulmonary Hypertension

  • Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.

Dyspnea

  • Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.

Hypertension

  • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.

Venous Thrombosis

  • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Provide thromboprophylaxis for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
  • For patients using hormonal contraception associated with a risk of thrombosis, consider an alternative method of effective contraception during treatment.

Infusion-Related Reactions

  • Infusion-related reactions, including life-threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion-related reactions.

Hemorrhage

  • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.

Thrombocytopenia

  • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure

  • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.

Thrombotic Microangiopathy

  • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

  • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.

Progressive Multifocal Leukoencephalopathy (PML)

  • Cases of PML, including fatal cases, have occurred. In addition to KYPROLIS, other contributary factors may include prior or concurrent use of immunosuppressive therapy. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. If PML is suspected, discontinue and initiate evaluation for PML including neurology consultation.

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

  • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse reactions was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.

Embryo-fetal Toxicity

  • KYPROLIS can cause fetal harm when administered to a pregnant woman.
  • Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should use effective contraception during treatment with KYPROLIS and for 3 months following the final dose.

Adverse Reactions

  • The most common adverse reactions in the combination therapy trials: anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection, thrombocytopenia, cough, dyspnea, and insomnia.
  • The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

Please see accompanying full Prescribing Information.

INDICATIONS

  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • KYPROLIS® is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

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