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
Patients in the phase 3 trial included those with baseline characteristics associated with poor prognostic factors. These baseline characteristics were inclusive of patients with renal impairment, with high-risk chromosomal abnormalities, who were refractory to lenalidomide, and those 75 years of age and older.1,2 For more information, view the 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). 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 phase 3 trial results.
SARCLISA is the first anti-CD38 antibody studied in a phase 3 trial in combination with Pd vs Pd alone. In the multicenter, open-label, randomized, phase 3 study, patients had received at least 2 prior lines of therapy, including lenalidomide and a PI.1
Patients received either SARCLISA 10 mg/kg administered as an IV 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 phase 3 trial design.
Patients in the phase 3 trial included those with renal impairment, with COPD or asthma, who were refractory to lenalidomide, and those 75 years of age and older.1 For more information on the trial population, view the phase 3 patient characteristics.
The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an IV infusion in combination with 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 IRRs, 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.
The most frequent adverse reactions (≥20%) in the phase 3 clinical trial were neutropenia (laboratory abnormality, 96% with SARCLISA + Pd vs 92% with Pd), upper respiratory tract infection (57% with SARCLISA + Pd vs 42% with Pd), IRRs (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 safety.
SARCLISA is an anti-CD38 mAb 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.1-3 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 Genzyme 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.
CareASSIST by Sanofi Genzyme 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 Genzyme 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.