Odronextamab as First-Line Therapy in Follicular Lymphoma | Rueme Birhiray, MD | #ASH24

Hello. My name is Dr. Ruemu Birhiray. I practice in Indianapolis, where I am an oncologist and hematologist. I practice at American Oncology Network or Hematology Oncology of Indiana, and I hold, a clinical professorship at Mary University Medical School. Also, I am the CEO of Indy Hematology Education, which is an educational and advocacy organization in Indianapolis.

So we've, presented today an abstract on a treatment of follicular lymphoma, as is called the Olympia one trial. And Olympia one is a study using a new class of medications that are called bispecific antibodies. What bispecific antibodies are they are medications that have been designed to activate the immune system. And they do say the very unique way they have two arms, hence the word bispecific.

One arm grabs the immune system grabs the T cells and the other, grabs the cancer cell and brings them together. And that process results in the killing of cancer cells. Almost sounds like science fiction, but it is true. And they are now approved in the treatment of multiple myeloma and treatment of lymphomas in the treatment of leukemias and even a treatment of small cell lung cancer.

Our study was designed to look at a new drug, which is called a Odronextamab. Odronextamab is a bispecific antibody that targets CD 20, which is on lymphoma cells and CD3, which is on immune cells, brings them together. And our hypothesis was since those drugs work so well in patients who have relapsed multiple times. For example, that same drug odroonextamab, when used in a different trial called the ELM one trial, we found that almost 70%, 67% of those patients had complete disappearance of their tumor.

So the hypothesis was, what if we want to use this in people who've never been treated with chemotherapy in non chemotherapy approach. So we did this in a very staggered ways in order to be deliberate in understanding, the efficacy and safety in patients. What I mean by staggered was the first 12 patients who were treated were treated with odronextamab without randomization.

And we wanted to understand that it is safe to do so. And that is the results that will be, presented today. We ended up with 13 patients because we had to replace one patient that left. And I am so glad to say to you that our results are great in a sense that the complete disappearance of tumor or complete response rate was 92%.

Really, it's 100%. And what I mean by that is the one patient who was removed was in evaluable. So that was calculated in a math. If you remove that patient, all the patients had complete disappearance of their tumors. If you include that patient, which is a way we do scientifically, it is 92.3%. Additionally, we looked at safety and we found out that the most common side effect of these medications, which is called cytokine release syndrome, occurred.

But it was grade one. And all I mean by that is that about, 60% of the patients had fevers. That is what grade one cytokine release syndrome is did not require hospitalization. And this was an all outpatient regimen, which is different from some of these same drugs in the space where patients need to be hospitalized. So we're very excited that this results are going to move the needle forward.

And so the randomized part of this study is upcoming. The dosing schedule of odronextamab initially starts with a weekly dosing regimen. And then after that it becomes every month and then ultimately every three months. And what we call the maintenance phase. So initially the patient is in a clinic for a prolonged period of time. We have to divide the doses sometimes into two days, in order to be able to give the dose and observe the patients.

But after that initial weekly dosing schedule and the patients go to monthly and then every three months, it really is not that intense for patients in terms of the amount of time they have to invest in receiving this therapy. So one of the things we found so far is that in a enrollment, we want to include a variety of patients, a diverse group of patients.

We have one achieve that yet so far. Almost all the patients that we've enrolled so far are white patients. We would like to include the variety of patients who have follicular lymphoma so that our results will be more representative of all the patients that we treat. This is a non chemotherapy approach and that is very important. Traditional chemotherapy,

As you know it's associated with nausea and vomiting immunosuppression patients getting ill. So far we haven't seen that. We've seen some infections in this study. But is all grade one and grade two which means that the patients really do not require hospitalization or anything much more than that. There's one patient who had grade three, which means that the patient did require more aggressive treatment.

But so far we feel very comfortable with the safety profile of this drug.