Frequently Asked Questions About SARCLISA^® (isatuximab-irfc)

SARCLISA is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).¹

For more information, view the IMROZ 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

SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed or 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

At a median follow-up time of 60 months, 63% of patients receiving SARCLISA + VRd remained on therapy, alive, and progression free vs 45% of patients receiving VRd alone. SARCLISA + VRd demonstrated superior mPFS (not reached vs 54 months with VRd alone), HR=0.60 (95% CI: 0.44, 0.81; P=0.0009).^1,2

• Superior rate of ≥CR with SARCLISA + VRd vs VRd alone (75% vs 64%, respectively; P=0.0160)¹
• 55% of patients receiving SARCLISA + VRd achieved MRD- in ITT vs 41% with VRd alone (P=0.0026)¹*
• 58% of patients receiving SARCLISA + VRd (n=265) achieved MRD- in ≥VGPR (ITT) vs 44% with VRd alone (n=181)¹
• 81% of patients receiving SARCLISA + VRd who achieved MRD- in ≥VGPR sustained it for ≥1 year at a median follow-up of 60 months (46.8% with SARCLISA + VRd vs 24.3% with VRd [ITT])^1-3

Limitations: Data for MRD- and sustained MRD- in ≥VGPR (ITT) ≥1 year were not multiplicity controlled and results are descriptive. Definitive conclusions cannot be made.

For more information, view the IMROZ phase 3 trial results

*Patients achieved both MRD- and a response of ≥CR.¹
CR=complete response; ITT=intent to treat; mPFS=median progression-free survival; MRD-=minimal (or measurable) residual disease negative/negativity; VGPR=very good partial response.
 

SARCLISA + VRd was studied in a multicenter, open-label, randomized, 2-arm, phase 3 study. Patients were newly diagnosed with multiple myeloma and were not eligible for a stem cell transplant.¹

Patients received either SARCLISA 10 mg/kg administered as an intravenous infusion in combination with bortezomib, lenalidomide, and dexamethasone (n=265), or bortezomib, lenalidomide, and dexamethasone alone (n=181); SARCLISA was administered once weekly during the 42-day induction cycle, every 2 weeks during cycles 2 to 17 (28-day cycles), and once a month for cycle 18 and beyond.¹

For more information, view the IMROZ 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 mPFS (not reached vs 20.27 months with Kd alone), HR=0.548 (95% CI: 0.37, 0.82; P=0.0032).¹

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.⁴

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).^1,5

As ORR did not reach statistical significance, ≥VGPR and CR were not tested for significance.⁵

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.

FDA=Food and Drug Administration; ORR=overall response rate; sCR=stringent complete 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

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 mPFS (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

The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with VRd, or Kd, or Pd. When administered with VRd, dosing occurs once weekly during the first 42-day induction cycle, every 2 weeks during cycles 2 to 17 (cycles 2 to 4 are 42 days each, cycles 5 to 17 are 28 days each), and once a month for cycle 18 and beyond. When administered with Kd or Pd, dosing occurs once weekly for cycle 1 and every other week for cycles 2 and beyond, with each treatment cycle consisting 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.^1,5

For more information, view infusion times

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

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

• Upper respiratory tract infections (65%, SARCLISA + VRd; 57%, VRd)
• Diarrhea (55%, SARCLISA + VRd; 49%, VRd)
• Fatigue (55%, SARCLISA + VRd; 50%, VRd)
• Peripheral sensory neuropathy (54%, SARCLISA + VRd; 61%, VRd)
• Pneumonia (45%, SARCLISA + VRd; 31%, VRd)
• Musculoskeletal pain (38%, SARCLISA + VRd; 33%, VRd)
• Cataract (38%, SARCLISA + VRd; 25%, VRd)
• Constipation (36%, SARCLISA + VRd; 41%, VRd)
• Peripheral edema (33%, SARCLISA + VRd; 33%, VRd)
• Rash (32%, SARCLISA + VRd; 34%, VRd)
• Infusion-related reaction (24%, SARCLISA + VRd; 1.1%, VRd)
• Insomnia (22%, SARCLISA + VRd; 24%, VRd)
• COVID-19 (22%, SARCLISA + VRd; 17%, VRd)

For more information, view IMROZ safety

In the IKEMA phase 3 trial, the most common adverse reactions (≥20%) were^1,5:

• 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%).⁶

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.^1,7,8

For more information, view the mechanism of action

CareASSIST is a free program for patients who have been prescribed SARCLISA and their caregivers. When your patients are enrolled in CareASSIST, they are matched with a dedicated Case Manager. Case Managers are experts regarding oncology access and resources and are trained to assist across the full spectrum of nonclinical support. They’ll work with you and your patients one-on-one to provide tailored, personalized assistance and can help with:

• Access and reimbursement support
• Financial assistance
• Lifestyle support and wellness resources

For more information about offerings, visit the CareASSIST website.
 

CareASSIST offers financial assistance that may help your patients with the cost of SARCLISA. The CareASSIST Copay Program offers copay assistance for eligible, commercially insured patients.†

Additionally, eligible patients who are uninsured or lack coverage could receive SARCLISA at no cost through the CareASSIST Patient Assistance Program. Our Case Managers can also identify other financial assistance programs that could help your patients with treatment costs.

To learn more about financial support options, visit the CareASSIST website.

^†Important Notice: Maximum benefit of $25,000 per calendar year. Prescription must be for an approved indication. Not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DoD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance programs. Not valid where prohibited by law. This offer is non-transferable, limited to one per person, and cannot be combined with any other offer or discount. Copay Program may apply to out-of-pocket expenses that occurs within 120 days prior to the date of the enrollment. Any savings provided by the program may vary depending on patients’ out-of-pocket costs. Sanofi reserves the right to modify or discontinue the programs at any time without notice.
 

Once enrolled, our Case Managers can help you to understand how SARCLISA is covered and support you and your patient through prior authorizations, denials, or any periods where there is a lapse in coverage. If you have any questions around access or for any patient that may be experiencing a delay or gap in coverage, please contact CareASSIST at 1-833-WE+CARE (1-833-930-2273), Mon-Fri, 9 AM - 6 PM ET.

To learn more about insurance support, 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.
 

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.