FAQs

Frequently Asked Questions About SARCLISA

SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1 For more information, view the ICARIA-MM phase 3 trial design.

SARCLISA is indicated, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.1 For more information, view the IKEMA phase 3 trial design.

At the final analysis of the phase 3 IKEMA trial (median follow-up: 44 months), SARCLISA + Kd doubled mPFS vs Kd alone (41.7 months vs 20.8 months with Kd alone), HR=0.59 (95% CI: 0.42, 0.83). At the interim analysis of the IKEMA trial (median follow-up: 20.7 months), SARCLISA + Kd demonstrated superior PFS (not reached vs 20.27 months with Kd alone), HR=0.548 (95% CI: 0.37, 0.82; P=0.0032).1,2

Patients in the IKEMA trial achieved deep responses. At the final analysis, ORR was 87% with SARCLISA + Kd vs 84% with Kd alone; ≥VGPR was 73% with SARCLISA + Kd vs 56% with Kd alone; CR was 44.1% with SARCLISA + Kd vs 28.5% with Kd alone; MRD- was 33.5% with SARCLISA + Kd vs 15.4% with Kd alone.2

At the interim analysis, ORR was 86.6% with SARCLISA + Kd (95% CI: 0.81, 0.91) vs 82.9% with Kd alone (95% CI: 0.75, 0.89; P=0.3859); ≥VGPR was 72.6% with SARCLISA + Kd vs 56.1% with Kd alone; CR was 39.7% with SARCLISA + Kd vs 27.6% with Kd alone; MRD- was 30% with SARCLISA + Kd (95% CI: 0.23, 0.37) vs 13% with Kd alone (95% CI: 0.08, 0.20).1,3

As ORR did not reach statistical significance, ≥VGPR and CR were not tested for
significance.3 For more information, view the IKEMA phase 3 trial results.

Study limitations

According to the FDA, using MRD to assess clinical benefit of a multiple myeloma treatment should only be assessed in patients who achieve a CR or sCR. In the IKEMA trial, MRD was assessed in patients who achieved ≥VGPR. Additionally, there was an amount of missing data that did not meet the FDA’s threshold for label inclusion. This analysis requires cautious interpretation and clinical significance of these data is unknown.

CR=complete response; mPFS=median progression-free survival; MRD=minimal (or measurable) residual disease; MRD-=MRD negative/negativity; ORR=overall response rate; PFS=progression-free survival; sCR=stringent complete response; VGPR=very good partial response.

SARCLISA + Kd was studied in a phase 3, multicenter, multinational, randomized, open-label study. Patients had received 1 to 3 prior lines of therapy.1,3

Patients received either SARCLISA 10 mg/kg administered as an intravenous infusion in combination with Kd (n=179) or Kd alone (n=123), administered weekly in the first cycle and every 2 weeks thereafter. Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.1 For more information, view the IKEMA phase 3 trial design.

In the phase 3 trial, SARCLISA + Pd demonstrated significantly superior median PFS (11.53 months with SARCLISA + Pd vs 6.47 months with Pd alone, HR=0.596, 95% CI: 0.44, 0.81). An improvement in ORR (60.4% with SARCLISA + Pd vs 35.3% with Pd alone), as well as ≥VGPR (31.8% with SARCLISA + Pd vs 8.5% with Pd alone) were also shown in this population.1 For more information, view the ICARIA-MM phase 3 trial results.

SARCLISA + Pd was studied in a multicenter, open-label, randomized, phase 3 study. Patients received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor.1

Patients received either SARCLISA 10 mg/kg administered as an intravenous infusion in combination with Pd (n=154) or Pd alone (n=153), administered weekly in the first cycle and every 2 weeks thereafter. Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.1 For more information, view the ICARIA-MM phase 3 trial design.

Patients in both the ICARIA-MM and IKEMA phase 3 trials included those with impaired renal function and high cytogenetic risk, as well as those who were refractory to lenalidomide, and those ≥65 years of age.1

For more information on the IKEMA trial population, view the IKEMA phase 3 patient characteristics.
For more information on the ICARIA-MM trial population, view the ICARIA-MM phase 3 patient characteristics.

*Poor prognostic factors may include renal insufficiency, older age, high cytogenetic risk, and refractoriness to prior therapies.4,5

The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with Kd or Pd. Weekly dosing transitions to every other week after the first cycle. Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.1 For more information, view dosing.

SARCLISA is a 250-mL fixed-volume infusion. Based on the infusion rates and incremental escalations, and in the absence of infusion-related reactions, the first infusion lasts 3 hours and 20 minutes, followed by 1 hour and 53 minutes for the second infusion, and 75 minutes for the third infusion onward.1 For more information, view infusion times.

In the IKEMA phase 3 trial, the most common adverse reactions (≥20%) were1,3:

  • Upper respiratory tract infection (67% SARCLISA + Kd; 57%, Kd)
  • Infusion-related reactions (46% SARCLISA + Kd; 3.3%, Kd)
  • Fatigue (42% SARCLISA + Kd; 32%, Kd)
  • Hypertension (37% SARCLISA + Kd; 32%, Kd)
  • Diarrhea (36% SARCLISA + Kd; 29%, Kd)
  • Pneumonia (36% SARCLISA + Kd; 30%, Kd)
  • Dyspnea (29% SARCLISA + Kd; 24%, Kd)
  • Insomnia (24% SARCLISA + Kd; 23%, Kd)
  • Bronchitis (24% SARCLISA + Kd; 13%, Kd)
  • Cough (23% SARCLISA + Kd; 15%, Kd)
  • Back pain (22% SARCLISA + Kd; 21%, Kd)

The safety profile at the longer follow-up remained consistent with the interim analysis, with the most frequent adverse reactions (all grades) in the SARCLISA + Kd group being infusion-related reactions (45.8%), diarrhea (39.5%), hypertension (37.9%), and upper respiratory tract infections (37.3%).2

For more information, view IKEMA safety.

The most frequent adverse reactions (≥20%) in the ICARIA-MM phase 3 trial were upper respiratory tract infection (57% with SARCLISA + Pd vs 42% with Pd), infusion-related reactions (38% with SARCLISA + Pd vs 0% with Pd), pneumonia (31% with SARCLISA + Pd vs 23% with Pd), and diarrhea (26% with SARCLISA + Pd vs 19% with Pd).1 For more information, view ICARIA-MM safety.

SARCLISA is an anti-CD38 monoclonal antibody that targets a specific epitope, resulting in multimodal effects. Selective binding triggers multiple mechanisms, leading to the death of CD38-expressing tumor cells. Preclinical evidence suggests that SARCLISA induces distinct antitumor activity.1,6,7 For more information, view the mechanism of action.

SARCLISA is supplied as 100 mg/5 mL and 500 mg/25 mL single-dose vials. SARCLISA should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake. Any unused portion of the solution should be discarded, and all materials that have been utilized for dilution and administration should be disposed of according to standard procedures.1 Please refer to the full Prescribing Information for more information.

CareASSIST by Sanofi for SARCLISA offers resources and support for your eligible patients, including access and reimbursement within the insurance landscape, financial assistance that can help mitigate the cost of SARCLISA, and resource support for both patients and caregivers.

To see the full scope of CareASSIST offerings and to find out if your patients are eligible, visit the CareASSIST website.

SARCLISA is available from authorized specialty distributors and specialty pharmacies. For a list of specialty distributors and specialty pharmacies, please refer to the Product Acquisition and Returns Flashcard or the Billing and Coding Guide.

CareASSIST by Sanofi for SARCLISA can help determine insurance coverage and options for patients and offers programs and services that can help eligible patients with the cost of SARCLISA. For more information and to see the full scope of CareASSIST offerings, visit the CareASSIST website.

Sanofi is committed to responsible pricing while bringing new therapies to patients. Aligned with these principles, SARCLISA is priced responsibly, taking into consideration providers, patients, payers, and society. For more information, please contact a representative.

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References: 1. SARCLISA [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. Data on file. sanofi-aventis U.S. LLC. 3. Moreau P, Dimopoulos M-A, Mikhael J, et al; IKEMA study group. Updated progression-free survival and depth of response in IKEMA, a randomized phase 3 trial of isatuximab, carfilzomib and dexamethasone (Isa-Kd) vs Kd in relapsed multiple myeloma. Presented at: the 8th World Congress on Controversies in Multiple Myeloma (COMy); May 12-15, 2022; Paris, France. 4. Jhaveri M, Romanus D, Raju A, et al. Real-world prescribing patterns in U.S. multiple myeloma (MM) patients refractory to lenalidomide in the front line. Poster presented at: 21st Congress of the European Hematology Association; June 9-12, 2016; Copenhagen, Denmark. 5. Hájek R, Jarkovsky J, Maisnar V, et al. Real-world outcomes of multiple myeloma: retrospective analysis of the Czech Registry of Monoclonal Gammopathies. Clin Lymphoma Myeloma Leuk. 2018;18(6):e219-e240. doi:10.1016/j.clml.2018.04.003 6. Attal M, Richardson PG, Rajkumar SV, et al; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. 7. Martin TG, Corzo K, Chiron M, et al. Therapeutic opportunities with pharmacological inhibition of CD38 with isatuximab. Cells. 2019;8(12):E1522. doi:10.3390/cells8121522