SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.¹

Patients in the phase 3 ICARIA-MM trial included those with baseline characteristics associated with a poor prognosis.^3-5 These baseline characteristics were inclusive of patients with renal impairment, who were refractory to lenalidomide, and those 75 years and older. The trial was also inclusive of patients who could have potential additional comorbidities, including COPD or asthma.⁵

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design

In the phase 3 IKEMA trial, SARCLISA demonstrated superior PFS when added to Kd. SARCLISA + Kd demonstrated superior median PFS of 3 years (35.7 months with SARCLISA + Kd vs 19.2 months with Kd alone; P=0.0021).¹

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design

In the phase 3 ICARIA-MM trial, SARCLISA + Pd significantly extended median PFS to nearly 1 year (11.53 months with SARCLISA + Pd vs 6.47 months with Pd alone; P=0.001). A consistent benefit across subgroups and an improvement in ORR (60.4% with SARCLISA + Pd vs 35.3% with Pd alone; P<0.0001) were also shown in this population.¹

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design

SARCLISA + Kd was evaluated in over 300 patients with relapsed and/or refractory multiple myeloma in a multicentre, multinational, randomised, open-label, 2-arm study. Patients had received 1 to 3 prior lines of therapy and were excluded if they were refractory to prior anti-CD38 therapy or received prior treatment with carfilzomib. 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.¹

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design

SARCLISA is the first anti-CD38 antibody to report results in a phase 3 trial in combination with Pd vs Pd alone. Over 300 patients with relapsed and/or refractory multiple myeloma were included in the multicentre, multinational, randomised, open-label, 2-arm study. Patients had received at least 2 prior lines of therapy, including lenalidomide and a PI. Patients received either SARCLISA 10 mg/kg administered as an IV infusion in combination with Pd (n=154) or Pd alone (n=153), administered in 28-day cycles until disease progression or unacceptable toxicity.^1,5

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design

Patients in both the IKEMA and ICARIA-MM trials included those with renal impairment, who were refractory to lenalidomide, and those 75 years and older. The ICARIA-MM trial was also inclusive of patients who could have potential additional comorbidities, including COPD or asthma.^2,5

For more information about the phase 3 IKEMA and ICARIA-MM study, view SARCLISA + Kd Trial Design and SARCLISA + Pd Trial Design

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

For more information, view SARCLISA Administration

SARCLISA is a 250-mL fixed-volume infusion. Based on the infusion rates and incremental escalations, 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. Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.¹

For more information, view Dosing Schedule

In IKEMA, the most frequent adverse reactions (≥20%) were infusion reactions (46%), hypertension (37%), diarrhoea (36%), upper respiratory tract infection (36%), pneumonia (29%), fatigue (28%), dyspnoea (28%), insomnia (24%), bronchitis (23%), and back pain (22%).²

For more information, view SARCLISA + Kd Adverse Reactions

In ICARIA-MM, the most frequent adverse reactions (≥20%) were neutropenia (47%), infusion reactions (38%), pneumonia (31%), upper respiratory tract infection (28%), diarrhoea (26%), and bronchitis (24%).¹

For more information, view SARCLISA + Pd Adverse Reactions

Quality of life, as assessed by the Global Health Status Score, was maintained during treatment. These results indicated that when the IV infusion of SARCLISA was added as a third drug to the 2-drug regimen of Pd or Kd, quality of life was maintained on the 3-drug regimens of both SARCLISA + Kd and SARCLISA + Pd as compared to the 2-drug regimen.^2,5-7

For more information, view SARCLISA + Kd Quality of Life and SARCLISA + Pd Quality of Life

SARCLISA is an anti-CD38 mAb that targets a specific epitope, resulting in multimodal effects. In vitro, SARCLISA directly destroys myeloma cells without requiring immune cells.^1,8

For more information, view Mechanism of Action