ikema: sarclisa + Kd

ikema Patient Profiles

Treating with sarclisa + carfilzomib and
dexamethasone (Kd) as early as first relapse
1

Current patient information

68 years of age

Cytogenetic risk
High: t(4;14)
Presence of gain(1q21)
ECOG PS 1
Older age

Diagnosis

Diagnosed 19 months ago after persistent worsening bone pain prompted MRI that identified humoral lesion

1st line

VRd induction → ASCT → bortezomib and lenalidomide maintenance (VGPR for 13 months posttransplant)

1st relapse

Rapid increase in M-spike and abrupt onset of bone pain with PET scan showing FDG-avid disease in the axial and appendicular skeleton

2nd-line treatment considerations for Alice

  • Rapid, aggressive disease progression
  • High cytogenetic risk
  • Presence of gain(1q21)
  • Double refractory to lenalidomide and bortezomib
  • Candidate for a triplet combination that includes a multimodal anti-CD38 mAb and a novel PI

consider sarclisa + Kd as early as first relapsefor patients with high cytogenetic risk and patients with rapid
disease progression1

PFS in the intent-to-treat population1

  • mPFS: Not yet reached (NR) with SARCLISA + Kd (n=179) vs 20.27 months with Kd alone (n=123), HR=0.548 (95% CI: 0.37, 0.82; P=0.0032)

This is a hypothetical case study portrayed by an actor and should not substitute a healthcare provider's decision.

ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; FDG=fluorodeoxyglucose; mAb=monoclonal antibody; mPFS=median progression-free survival; MRI=magnetic resonance imaging; PET=positron emission tomography; PFS=progression-free survival; PI=proteasome inhibitor; RRMM=relapsed or refractory multiple myeloma; VGPR=very good partial response; VRd=bortezomib, lenalidomide, dexamethasone.

PFS results in patients with cytogenetic
abnormalities and older age

In ikema, 14% of patients were positive for t(4;14), 42% were positive
for gain(1q21), and 49% were of older age2*

PFS in patients with presence of t(4;14)

39%
Reduction in the risk of
disease progression

HR=0.61 (95% CI: 0.25, 1.52)

PFS in patients with presence of gain(1q21)

45%
Reduction in the risk of
disease progression

HR=0.55 (95% CI: 0.32, 0.95)

PFS in older patients (aged ≥65 years)

50%
Reduction in the risk of
disease progression

HR=0.50 (95% CI: 0.28, 0.89)

Median follow-up time of 20.7 months.1

See the full ikema patient subgroup data

Study limitations

Prespecified subgroup analysis; subgroups were not powered to show differences between treatment arms.

*High-risk cytogenetic status was defined as the presence of del(17p) and/or t(4;14) and/or t(14;16). Chromosomal abnormality was considered positive if present in at least 30% of analyzed plasma cells, except for del(17p), where the threshold is at least 50%. Gain(1q21), present in 42% of patients, was also analyzed and was considered positive if there were at least 3 copies in at least 30% of analyzed plasma cells.1,2

Get in touch with your local sarclisa representative

Current patient information

55 years of age

Cytogenetic risk
Standard
ECOG PS 0
Renal function (eGFR)
44 mL/min/1.73 m2

Diagnosis

Diagnosed ~3 years ago after acute onset of renal insufficiency and hypercalcemia

1st line

VRd induction → ASCT → lenalidomide maintenance (CR for 27 months posttransplant;
recovery of renal function)

1st relapse

Relapsed with hypercalcemia, anemia, and recurring renal insufficiency

2nd-line treatment considerations for Charles

  • High symptom burden at early relapse on lenalidomide maintenance
  • Impaired renal function
  • Refractory to lenalidomide
  • Candidate for a triplet regimen that includes a multimodal anti-CD38 mAb and a novel PI

consider sarclisa + Kd as early as first relapsefor patients with impaired renal function and
patients refractory to lenalidomide1

PFS in the intent-to-treat population1

  • mPFS: Not yet reached (NR) with SARCLISA + Kd (n=179) vs 20.27 months with Kd alone (n=123), HR=0.548 (95% CI: 0.37, 0.82; P=0.0032)

This is a hypothetical case study portrayed by an actor and should not substitute a healthcare provider's decision.

ASCT=autologous stem cell transplant; CR=complete response; ECOG PS=Eastern Cooperative Oncology Group performance status; eGFR=estimated glomerular filtration rate; mAb=monoclonal antibody; mPFS=median progression-free survival; PFS=progression-free survival; PI=proteasome inhibitor; RRMM=relapsed or refractory multiple myeloma; VRd=bortezomib, lenalidomide, dexamethasone.

PFS results in patients with renal impairment and
patients refractory to lenalidomide

In ikema, 20% of patients had impaired renal function and 33% were
refractory to lenalidomide1,2

PFS in patients with renal impairment2

66%
Reduction in risk
of progression
or death

Median follow-up time of 20.7 months. PFS assessed by independent response committee. Events occurring more than 8 weeks after the last valid disease assessment are censored.

PFS in patients refractory to lenalidomide2

39%
Reduction in the risk of
disease progression

HR=0.61 (95% CI: 0.34, 1.10)

See the full ikema patient subgroup data

Study limitations

All subgroups were prespecified except the lenalidomide-refractory subgroup. Subgroups were not powered to show differences between treatment arms.

Get in touch with your local sarclisa representative

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