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

Patient Profile Brochure

Review profiles of potential candidates for treatment with
sarclisa, including patient types with renal impairment and high
cytogenetic risk

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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

Patient Profile Brochure

Review profiles of potential candidates for treatment with
sarclisa, including patient types with renal impairment and high
cytogenetic risk

Download the resource.
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