Epcoritamab + R-Squared: Interim Results

The makers of the bispecific Epcoritamab just issued a press releasewith some interim results from the phase 3 clinical trial for Epcoritamab and R-Squared (Revilid + Rituxan) for Relapsed/Refractory patients with Follicular Lymphoma. The press release points out some very good news. The combination has an Overall Respose Rate of 95.7%, an improvement over R-Squared alone (which has an ORR of 89%). It also had a higher Progression Free Survival; it "reduced the risk of disease progression or death by 79%."

The plan is to present the results at the ASH conference in December, where they will present all of the data. The FDA agreed to a priority review of the combination last month, meaning they should issue a ruling by November 30 (which would be before the ASH conference).

All of this sounds great, but I have some questions. And, to be clear, I'm not suggesting anybody is doing anything wrong.

Te press release gives very little detail. And there's a good reason for this -- they're holding off on releasing any details until the ASH conference, which makes sense. This is a "scheduled interim analysis," meaning they had planned to look at the results they had so far at this point in the trial. Because they haven't competed the trial, they don't want to give too much detail yet.

The other side to all of this is that they need to keep investors happy. A little good news will do that, and a fairly general statement with some plans for the future won't hurt either.

But for me, it all raises more questions than it provides answers. Last year, there were some safety concerns about Epcoritamab, though they were explained by the trial taking place during the Covid pandemic, when some trial participants had lower immunity which caused some side effects. The press release here says that there were no new safety issues with this combination -- only the side effects that were already known for the three different elements. But if there were already some concerns, saying this doesn't really answer the initial questions about safety.

Again, I'm not saying anybody is doing anything wrong. For me, this isn't really an issue with Epcoritamab or its makers. It's more about frustration with the larger system for approving treatments, and the place of the patient in it all.

I'm looking forward to the ASH conference, so we can see more of the data that this FDA application is based on. I have little doubt that the data presented will be positive and encouraging for patients. I hope my questions and concerns are answered. I just wish that I didn't have to have so many of them along the way.