ASCO: Epcoritamab and Safety

As I have said before, this year's ASCO meeting was short on Follicular Lymphoma presentations. One of the big focuses for FL was on bispecifics, and Epcoritamab made its presence known.

Epcoritamab is a bispecific, attaching to CD20 on the cancer cell and CD3 on the T cell. (You can read more about bispecifics in my last post.) It was approved for Diffuse Large B Cell Lymphoma (including DLBCL that arose from transformed Follicular Lymphoma. In February, it was granted accelerated review for Relapsed/Refractory Follicular Lymphoma. A decision is expected within a  few weeks.

So it's no surprise that it got lots of attention at ASCO this year. My guess is that it will be approved. I have absolutely no insider knowledge about this. Just in my observation, the makers of treatments tend to keep quiet if they are expecting bad news, and Epcoritamab isn't being quiet.

In one ASCO presentation, researchers focused on safety. Because Epcoritamab is already approved in the U.S. and Europe, there is a good deal of data on its side effects. Like other bispecifics (and like CAR-T), Cytokine Release Syndrome (CRS) is a concern. (As a reminder --  CRS happens when the body releases too many immune cells all at once. With treatments like bispecifics and CAR-T, the whole point is to get the immune system to go after the cancer cells. But when that happens, the immune cells doing their work will signal to other immune cells to come and help. Those signals are sent through cytokines, and a fast build up on cytokines results in fever, low pressure, breathing trouble, and other dangerous issues.) In the ASCO presentation "EPCORE NHL‑1 follicular lymphoma (FL) cycle (C) 1 optimization (OPT) cohort: Expanding the clinical utility of epcoritamab in relapsed or refractory (R/R) FL," researchers looked specifically at patients who at potential issues with CRS and tried to find ways to identify the problem early.  Patients were hydrated and given dexamethasone, and anti-inflammatory drug, and were able to avoid hospitalization. Similar studies seem common in CAR-T as well. There is an increased understanding of how common CRS is and how important it is to treat it as soon as possible.

In another presentation focused on safety, "Subcutaneous epcoritamab (SC epcor) administered outpatient (outpt) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL): Results from phase 2 EPCORE NHL-6," patients were given subcutaneous Epcoritamab (by an injection rather than by an IV) and monitored for side effects. The results were similar to the other presentation, in that there was some CRS, but it was carefully monitored and treated, and there were no hospitalizations required. 

The two presentations are obviously related, but they are looking at different forms of the treatment. An IV has potentially different side effects than an injection (subcutaneous Rituxan had to go through a whole different process to be approved by the FDA, 20 years after Rituxan was first approved). An IV can be slowed down, as it often is with Rituxan, because of allergic reactions (that happened with me when I received it), whereas an injection gets all of it to you at once. But these two studies show that Epcoritamab can be administered safely no matter the form. Again, there just seems to be an increased awareness of the likely side effects that come with stimulating the immune system to intensely. 

And I'm sure the FDA has safety in mind as they finish reviewing the application for R/R Follicular Lymphoma. It's always a concern, of course, but even more so lately, it seems, as newer types of treatments are approved and new safety concerns arise. 

I'm guessing that I will have news about Epcoritamab's approval very soon. Stay tuned.