Glossary:
Overall response rate: the percentage of patients whose tumors shrink or disappear after treatment.
Complete response rate: the percentage of patients whose tumors disappear completely after treatment.
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Expert Explains the Side Effects of Ordspono in R/R Follicular Lymphoma
Dr. Deepa Jagadeesh discusses Ordspono's potential FDA approval for relapsed/refractory follicular lymphoma, highlighting its manageable toxicity and low CRS rate.
The potential Food and Drug Administration approval of Ordspono (odronextamab) for relapsed or refractory follicular lymphoma (FL) was discussed by Dr. Deepa Jagadeesh, a hematologist and oncologist at Cleveland Clinic Main Campus. FL is a low-grade lymphoma that requires multiple treatments, but response rates typically decrease over time, she mentioned. The approval of Ordspono, a bispecific antibody with manageable toxicity and high efficacy, would offer a treatment for patients with limited options.
Jagadeesh reviewed the ELM-1 and EML-2 trials, which showed a 91% overall response rate and a 72% complete response rate in patients with relapsed/refractory FL. The safety profile showed low rates of cytokine release syndrome (CRS) following a split-dose regimen.
Jagadeesh noted that Ordspono is ideal for patients who cannot undergo CAR-T cell therapy or have failed previous treatments. Its low CRS rate and potential for fewer hospitalizations make it a possible option for improving patient quality of life.
Transcript:
The main side effects that we noticed with this class of drug is CRS, which we call it, cytokine release syndrome. So, this usually happens with patients — most of all the bispecific antibodies are given in a dose escalating fashion. So, patients receive a smaller dose first than a higher dose on day eight, and day 15 they get a higher dose. So, as the dose is escalated, when they get the full dose, most patients, there is a risk of experiencing CRS. So, the cytokine release syndrome presents very similar to how cytokine release syndrome happens in CAR-T patients. So, patients can have fever, they can have low blood pressure, high heart rate, and also in some patients, they may experience difficulty breathing because they're hypoxic and with low oxygen levels.
So, when these things happen, we usually tell the patients that if they are admitted in the hospital, then they will get a drug called tocilizumab [Actemra] to kind of counteract this. If patients are in the outpatient setting, we give them very specific instructions on how often do they need to check their vitals, and what are the most important things when they need to go to the nearest emergency room or to call the treating physician's office immediately when they experience these symptoms, so that they can receive the [Actemra (tocilizumab)] and treatment for this, which is very preventable from progressing.
The other most common side effect that we see is what we call ICANS, that is the immune effector cell associated neurotoxicity syndrome. So basically, that means is that the patients may experience some neurotoxicity, it can have a wide range of presentations. So, some patients may experience some confusion, some headache, and sometimes they may forget how to write a sentence or spell a word. It affects memory.
Transcript has been edited for clarity and conciseness.
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