ikema:
sarclisa + CARFILZOMIB
AND DEXAMETHASONE (Kd)
ikema Patient Profile
Treating with sarclisa + Kd as early as
first relapse1
Meet Alice: An RRMM patient with high cytogenetic risk and rapid disease progression on first-line maintenance therapy
Hypothetical patient case.
Hypothetical patient case.
Current patient information
Cytogenetic risk: High
iFISH positive for 1q21+ and t(4;14)
ECOG PS 1
Older age
(68 years)
Diagnosis:
Diagnosed 19 months ago after persistent worsening bone pain prompted MRI that identified humeral 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
Alice's 2nd-line treatment considerations
Rapid, aggressive disease progression on lenalidomide maintenance
Lenalidomide-refractory myeloma after first relapse is associated with shorter PFS2
Presence of 1q21+
Defined as high risk by the National Comprehensive Cancer Network (NCCN®), IMWG, and mSMART guidelines3-5
Copy number gain of the 1q21 chromosome is common in myeloma (~40% in NDMM; 50% to 80% in RRMM) and associated with high disease burden and poor outcomes6,7
ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; FDG=fluorodeoxyglucose; iFISH=interphase fluorescence in situ hybridization; IMWG=International Myeloma Working Group; MRI=magnetic resonance imaging; mSMART=Mayo Clinic Stratification for Myeloma and Risk-adapted Therapy; NDMM=newly diagnosed multiple myeloma; PET=positron emission tomography; PFS=progression-free survival; RRMM=relapsed or refractory multiple myeloma; VGPR=very good partial response; VRd=bortezomib, lenalidomide, dexamethasone.
Why SARCLISA May Be Right for Patients Like Alice
SARCLISA + Kd was studied in patients like Alice1
44%
Received 1 prior line of therapy
33%
Refractory to lenalidomide
42%
Presence of 1q21+
IKEMA FINAL ANALYSIS:
44 months median follow-up
Unprecedented results:
~42 months mPFS with SARCLISA + Kd
Longest ever reported in a phase 3 trial that included lenalidomide-refractory patients1,8-12*
*Based on a review of published phase 3 trials that included lenalidomide-refractory patients with RRMM. Interpret with caution, as various factors, including patient population, differ between trials.
SARCLISA + Kd
IKEMA
Final analysis: mPFS 41.7 months with SARCLISA + Kd (n=179) vs 20.8 months with Kd alone (n=123), HR=0.59 (95% CI: 0.42, 0.83) at a median follow-up of 44 months8
Interim analysis: mPFS NR with SARCLISA + Kd vs 20.27 months with Kd alone, HR=0.548 (95% CI: 0.37, 0.82; P=0.0032) at a median follow-up of 20.7 months1
SARCLISA + Kd
IKEMA
Final analysis: mPFS 41.7 months with SARCLISA + Kd (n=179) vs 20.8 months with Kd alone (n=123), HR=0.59 (95% CI: 0.42, 0.83) at a median follow-up of 44 months8
Interim analysis: mPFS NR with SARCLISA + Kd vs 20.27 months with Kd alone, HR=0.548 (95% CI: 0.37, 0.82; P=0.0032) at a median follow-up of 20.7 months1
Trial results in patients refractory to lenalidomide
and patients positive for 1q21+13
Reduction in the risk of disease progression or death in patients treated with SARCLISA + Kd vs Kd alone
Study limitations
The lenalidomide-refractory subgroup was not prespecified. Subgroups were not powered to show differences between treatment arms.
Consider SARCLISA + Kd at first relapse for your appropriate patients with RRMM and high-risk factors1
IKEMA study design: A multicenter, multinational, randomized, open-label, 2-arm, phase 3 study evaluated the efficacy and safety of SARCLISA in 302 patients with RRMM who had received 1 to 3 prior therapies. Patients received either SARCLISA 10 mg/kg administered as an IV infusion in combination with Kd (n=179) or Kd alone (n=123), administered in 28-day cycles until disease progression or unacceptable toxicity. SARCLISA was given weekly in the first cycle and every 2 weeks thereafter. PFS was the primary endpoint; ORR, ≥VGPR, CR, MRD-, and OS were key secondary endpoints.1,13
Major guidelines recommend SARCLISA + Kd at first
relapse in your lenalidomide-refractory patients
National Comprehensive Cancer Network® (NCCN®) recommends isatuximab-irfc (sarclisa) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma as a Category 1 Preferred option in combination with carfilzomib and dexamethasone or with pomalidomide and dexamethasone3:
- ✓ For early relapses (1-3 prior therapies)†
- ✓ Option for patients refractory to either lenalidomide or bortezomib
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Recommendation for isatuximab-irfc (SARCLISA) in combination with carfilzomib and dexamethasone based on results of interim analysis.
†After 2 prior therapies including lenalidomide and a proteasome inhibitor for isatuximab-irfc in combination with pomalidomide and dexamethasone.
IMWG
IMWG guidelines recommend SARCLISA + Kd as a grade 1A‡ preferred option for lenalidomide-refractory patients at first relapse and SARCLISA + Pd as a grade 1A preferred option for patients at second or later relapse.14
mSMART
mSMART guidelines recommend SARCLISA + Kd and SARCLISA + Pd at first relapse in patients who are refractory to lenalidomide.5
‡Strong recommendation, high-quality evidence.14
CR=complete response; mPFS=median progression-free survival; MRD-=minimal (or measurable) residual disease negativity; NCCN=National Comprehensive Cancer Network (NCCN®); NR=not reached; ORR=overall response rate; OS=overall survival; Pd=pomalidomide and dexamethasone.
See how SARCLISA was studied in two phase 3 trials that included lenalidomide-refractory patients1
Review the broad and diverse
patient population studied in
the phase 3 IKEMA trial1
Get in touch with your local sarclisa representative
IKEMA Trial Summary Brochure
An informative brochure that includes the IKEMA trial results for SARCLISA + Kd vs Kd alone
