- 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
Kd vs Vd study results
Superior median progression-free survival: 18.7 months for Kd vs 9.4 months for Vd1
Kd 56 mg/m2 significantly increased median PFS by 9.3 months vs Vd1
Primary endpoint: PFS1
Post hoc analysis: progression-free survival at 12 months: 62.7% with Kd vs 41.5% with Vd3
Progression-free survival at 12 months1,3
Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd3
Progression-free survival at 24 months1,3
Exploratory analysis: At first relapse, Kd demonstrated a 12.1-month increase in median progression-free survival over Vd4
1 previous line of therapy4
Exploratory analysis: Kd demonstrated a 6.5-month increase in median progression-free survival over Vd in patients who had received 2 or 3 previous lines of therapy4
2 or 3 previous lines of therapy4
Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure5
In an exploratory subgroup analysis of patients with prior exposure to bortezomib, results were consistent with overall PFS results5,*
Prior bortezomib exposure5
Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure5,*
Bortezomib naive5
Post-hoc analysis: Frail-subgroup patients with Kd 56 mg/m2 experienced mPFS of 18.7 months vs 6.6 months with Vd7,*,†
Patients’ age, ECOG PS, and medical history (comorbidities) were used to evaluate frailty status7,*
Median PFS
Kd 56 mg/m2 significantly increased median overall survival by 7.6 months vs Vd (Kd 47.6 months vs Vd 40.0 months)1
Kd reduced the risk of death by 21% compared to Vd1
Secondary endpoint: overall survival1
Kd 56 mg/m2 doubled patients' chance of achieving a complete response or better (Kd vs Vd)1
Secondary endpoint: responses by category1
- Post hoc analysis: rates of CR or better in the Kd vs Vd study were consistent regardless of number of prior lines of therapy (1 prior line: 12% Kd vs 8% Vd compared with 2 or 3 prior lines: 13% Kd vs 5% Vd)4
- Demonstration of CR by line of therapy was not a study objective
IMWG uniform response criteria8
Response | Multiple myeloma response criteria |
---|---|
Stringent complete response (sCR) | CR as defined below plus normal free light chain (FLC) ratio* and absence of clonal cells in bone marrow biopsy by immunohistochemistry† |
Complete response (CR) | Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates |
Very good partial response (VGPR) | Serum and urine M‑protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M‑protein plus urine M‑protein level < 100 mg/24 hours |
Partial response (PR) |
≥ 50% reduction of serum M‑protein and reduction in 24‑hour urinary M‑protein by ≥ 90% or to < 200 mg/24 hours If the serum and urine M‑protein are unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M‑protein criteria If serum and urine M‑protein are unmeasurable, and serum free light assay is also unmeasurable, ≥ 50% reduction in plasma cells is required in place of M‑protein, provided baseline bone marrow plasma cell percentage was ≥ 30%. In addition to these criteria, if present at baseline, a ≥ 50% reduction in the size (SPD)‡ of soft tissue plasmacytomas is also required |
Post hoc analysis: the longer patients stayed on treatment, the better their chances of reaching ≥ CR6
Cumulative rates of ≥ CR6
- Adding KYPROLIS® to dexamethasone doubled the patient's chance of achieving CR or better vs Vd1
- Post hoc analysis: demonstration of complete response over time was not a study objective
Meet Joseph, a 76-year-old African American male
Hypothetical Kd case study of a standard-risk* patient with multiple myeloma at first relapse
Time for a deep and durable response
- Retired high school history teacher, widowed
- Amateur musician, enjoys teaching his grandchildren how to play guitar
- Type 2 diabetes moderately well controlled with medication and diet
- COPD limits his physical activity
- Traveling to and from appointments can be challenging
- Standard-risk cytogenetics*
- ECOG PS 2