FDA Application for Epcoritamab + R-Squared

A quick note about some treatment news: the makers of Epcoritamab are submitting an application for approval for Epcoritamab + R-Squared as a treatment for patients with Relapsed or Refractory Follicular Lymphoma.

Some reminders:

Epcoritamab is a bispecific antibody. Like other bispecifics, it works by bringing together a lymphoma cell and an immune cell (a T cell) by attaching itself to both. This allows the T cell to eliminate the cancer cell. Bispecifics are one of those treatment types that gets oncologists very excited.

Last December at the ASH conference, researchers presented data about Epcoritamab combined with R-Squared, from the phase 2 clinical trial called EPCORE-NHL-1. The data is being used for the application with the FDA comes from a phase 3 trial called EPCORE-FL-1. 

The ASH data was very strong, with an Overall Response Rate of 96%, and a Complete Response Rate of 87%. After a median follow up of 24 months, an estimated 69% of patients were still responding to the treatment, and 75% of those with a Complete Response had maintained their Complete Response. 

So what is the Overall Response Rate for EPCORE-FL-1?

I'm not sure.

The ORR is good enough that it's the reason for the application, but the press release says the researchers plan to present that data at a medical conference in 2025. Maybe that will be ASCO in a few weeks? Maybe the Lugano conference in Switzerland soon after that? Maybe another conference later in the year?

So for now, there's no data available for effectiveness or safety for the combination. That's not a reason for alarm or suspicion. The FDA application will need to be perfect, and checking and reaffirming the data is expected. So we'll have to wait and see what gets announced.

(Am I saying one of my end-of-year predictions might come true? Who knows. We'll see what the data shows and what the FDA says.)

But a potential new treatment is always cause for excitement. Here's hoping it all works out.

More to come soon: some ASCO previews, some thoughts about watching and waiting vs Rituxan, and other fun things.