- 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. ... Read More
Results by patient type
These data have been compiled to provide an overview of efficacy with respect to one or more characteristics that may apply to this patient type, and certain data may also apply to other patient types represented herein.
These data were compiled from post hoc analyses of the KRd vs Rd and Kd vs Vd studies to provide a categorical overview of efficacy by patient type. The four defined patient types are based on one or more characteristics that may be used to differentiate your patients with relapsed or refractory multiple myeloma.
KYPROLIS®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively5,†,‡
†KRd 27 mg/m2 as a triplet therapy
8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.00015
‡Kd 56 mg/m2 as a doublet therapy
9.3-month increase in median PFS: 18.7 months (Kd) vs 9.4 months (Vd); hazard ratio (Kd/Vd) = 0.53 (95% CI: 0.44-0.65); one-sided P < 0.00015
CI = confidence interval; ECOG = Eastern Cooperative Oncology Group; FISH = fluorescence in situ hybridization; IMWG = International Myeloma Working Group; ISS = International Staging System; Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone; PC = plasma cell; Rd = lenalidomide and dexamethasone; R-ISS = Revised International Staging System; Vd = VELCADE® (bortezomib) and dexamethasone.
Analyses by patient characteristic: high-risk/fit
High-risk/fit patient description§
- This is a patient who is likely to have high cytogenetic risk (as determined by FISH sequencing)
- Additionally, this patient may be young (< 75 years of age), or older with good physical function (ECOG Performance Status 0-1), and normal renal and hepatic function
- KRd
PFS and ≥ CR6
PFS
PFS, ORR, and Rate of ≥ CR7
PFS
PFS and ORR8
PFS
PFS and ORR9
PFS
PFS10
Analyses by patient characteristic: standard-risk/fit
Standard-risk/fit patient description**
- This is a patient who most likely does not have high cytogenetic risk (determined by FISH) or high tumor burden at the time of relapse
- Additionally, this patient may be young (< 75 years of age), or older with good physical function (ECOG Performance Status 0-1), ISS I, and normal renal and hepatic function
- KRd
PFS and ≥ CR6
PFS
PFS and ORR8
PFS
PFS and ≥ CR10
PFS
PFS and ORR9
PFS
PFS10
Analyses by patient characteristic: high-risk/frail
High-risk/frail patient description††
- This is a patient who is likely to have high cytogenetic risk (as determined by FISH sequencing)
- Additionally, this patient may be older (≥ 75), ECOG of at least 2, R-ISS II or III, renally impaired, hepatically impaired, wheelchair bound, and have comorbidities such as diabetes
- KRd
- Kd
PFS and ≥ CR6
PFS
PFS, ORR, and ≥ CR7
PFS
PFS and ORR8
PFS
PFS and ORR9
PFS
PFS, ORR, and ≥ CR11
PFS
PFS7
PFS, OS, ORR, and ≥ CR12
PFS
PFS, OS, ORR, and ≥ CR12
PFS
PFS and ORR13
PFS
Reduced risk in disease progression or death and ORR9
Reduced risk for progression or death
(HR = 0.61; 95% CI: 0.47-0.79)
Median PFS has not been reached for Kd vs
10.2 months for Vd
PFS and ORR13
PFS
PFS and ORR at first relapse13
PFS
PFS, OS, and ORR14,15
PFS
PFS, OS, and ORR14,15
PFS
PFS, OS, and ORR14,15
PFS
Analyses by patient characteristic: standard-risk/frail
Standard-risk/frail patient description‡‡
- This is a patient who most likely does not have high cytogenetic risk (determined by FISH) or high tumor burden at the time of relapse
- Additionally, this patient may be older (≥ 75), ECOG 2 or more, R-ISS I, renally impaired, hepatically impaired, wheelchair bound, and have comorbidities such as diabetes
- Kd
PFS, ORR, and ≥ CR11
PFS
PFS and ORR13
PFS
PFS and ORR13
PFS
PFS and ORR at first relapse13
PFS
PFS, OS, and ORR14,15
PFS
PFS, OS, and ORR14,15
PFS
PFS, OS, and ORR14,15
PFS
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.5,16,17
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. 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.5,18