Isatuximab

Phase 3 ICARIA-MM trial, showing promising efficacy and safety for isatuximab in combination with pomalidomide and low-dose dexamethasone in relapsed/refractory MM.

Isatuximab, which is a CD38 targeting antibody.


Tradename Sarclisa.

It is different from daratumumab, because it has a different isotope for binding.

As a monotherapy, response rates are comparable to what we see with daratumumab.

IT requires a short infusion time and relatively limited pre‑med.

Because it activates compliment to a lesser degree it has a favorable tolerability profile.

The rates of infusion reactions are quite low.

ICARIA trial revealed the combination with isatuximab combined with pomalidomide, showed an impressive response rate in relapsed/refractory patients.

Isatuximab is given typically weekly for the first month, and then can be converted onto every 2 weeks thereafter.

Pomalidomide which was given 3 weeks on and 1 week off.

Over 90% of the patients were refractory to lenalidomide.

Associated, essentially with a doubling of PFS.

There was 12‑month median PFS for the 3 drugs, and a six‑month PFS for the 2 drugs.

There was effectively a doubling of response rate from around 35%, to approximately 60% to 70% in the 3-drug combination.

Infusion reactions were low in terms of incidents.

Seeing a trend in favor of overall survival advantage to 3 drugs over the 2.

The use of isatuximab early in the relapsed/refractory course conferred trend favoring survival.

Approved in combination of carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.


Approved with  addition of isatuximab to the combination of carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy,.


The anti-CD38 treatment of choice for patients with relapsed or refractory multiple myeloma.


Phase 3 IKEMA trial showed that the triplet reduced the risk of disease progression or death by 45% vs Kd alone in this patient population.


The median progression-free survival had not yet been reached with the isatuximab combination.


No statistically significant difference in objective response rate was observed with the triplet vs the doublet, at 86.6% vs 82.9%, respectively; complete response rates were 39.7% vs 27.6%, respectively


Most  common adverse events;  respiratory tract infection, infusion-related reactions, fatigue. hypertension, diarrhea, pneumonia, dyspnea, and cough


Serious AEs in the isatuximab combination: were pneumonia and upper respiratory tract infections.


The addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%.


The study reinforces the potential for isatuximab to become a standard of care in relapsed or refractory multiple myeloma.



Leave a Reply

Your email address will not be published. Required fields are marked *