FAQs

Frequently asked questions about SARCLISA + Pd

How does SARCLISA work?

SARCLISA is an anti-CD38 monoclonal antibody that targets a specific epitope, resulting in multimodal anti-tumour effects. Pre-clinical evidence suggests that SARCLISA works synergistically with pomalidomide and dexamethasone.1

For more information, view the Mode of action video.

Which of my patients are appropriate for treatment with SARCLISA + Pd?

SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor 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.1-4 These baseline characteristics were inclusive of patients with renal impairment, with COPD or asthma, refractory to lenalidomide, and those older than age 75.1,2

For more information about ICARIA-MM, view the Phase 3 SARCLISA + Pd trial design.

How was SARCLISA + Pd studied?

SARCLISA was the first anti-CD38 antibody studied in a Phase 3 trial in combination with Pd vs. Pd alone. Over 300 patients with relapsed and 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.2

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.2

For more information about the Phase 3 ICARIA-MM study, view SARCLISA + Pd trial design.

How effective is SARCLISA + Pd?

In the Phase 3 ICARIA-MM trial, SARCLISA + Pd demonstrated significantly superior median PFS (11.53 months with SARCLISA + Pd vs. 6.47 months with Pd alone).2

A consistent benefit across subgroups and an improvement in ORR (60% with SARCLISA + Pd vs. 35% with Pd alone) were also shown in this population.2

For more information about ICARIA-MM, view the Phase 3 SARCLISA + Pd trial results.

Can I prescribe SARCLISA combination treatment to my patients with comorbidities such as renal impairment or chronic obstructive pulmonary disease (COPD)?

There is no contraindication to patients with COPD or renal impairment to receive SARCLISA. Patients in the Phase 3 ICARIA-MM trial included those with renal impairment, with COPD or asthma, refractory to lenalidomide and those older than age 75.2

For more information about the Phase 3 ICARIA-MM study, view SARCLISA + Pd trial design.

What is the recommended dose for SARCLISA?

The recommended dose of SARCLISA is 10 mg/kg body weight administered as an IV infusion in combination with Pd. 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.1

For more information, view SARCLISA + Pd dosing & administration.

How long does a typical infusion of SARCLISA last?

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 last 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 SARCLISA + Pd dosing & administration.

What were the most common adverse reactions in patients receiving SARCLISA + Pd?

The most frequent adverse reactions (≥20%) in the ICARIA-MM trial were neutropenia (46.7%), infusion-related reactions (38.2%), pneumonia (30.9%), upper respiratory tract infection (28.3%), diarrhoea (25.7%), and bronchitis (23.7%).1

For more information, view SARCLISA + Pd adverse reactions.

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