Evaluating Epcoritamab Plus Rituximab and Lenalidomide for Frontline Treatment and Epcoritamab as Maintenance Therapy for Patients With FL
Results from EPCORE NHL‑2 Trial arms 6 and 7
Results from EPCORE NHL‑2 Trial arms 6 and 7
According to data from the EPCORE NHL‑2 trial arms 6 and 7, epcoritamab plus rituximab and lenalidomide continued to demonstrate deep, durable responses for previously untreated follicular lymphoma (FL), and epcoritamab as maintenance treatment after standard of care therapy showed efficacy and manageable safety for patients with FL.
“The data warrant further evaluation of epcoritamab-based, chemotherapy-free regimens in FL,” Joshua Brody, MD, Icahn School of Medicine at Mount Sinai, New York, New York, and coauthors wrote.
This research was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Transcript:
Hi, my name is Josh Brody. I run the lymphoma immunotherapy program at the Icahn School of Medicine at Mount Sinai in New York. If you haven't heard of New York, it's lovely. It's right next to Jersey. Today I'm going to talk here at ASCO about an exciting data set. We're going to present some data from arm 6 and 7 of the EPCORE NHL-2. This, as you can hear, is a multi-arm trial, a multi-center, multinational trial, looking at epcoritmab, CD3-CD20 bispecific antibody, and immunotherapy, in combination with different standards of care.
Arm 6 is an interesting one because it's finally bringing this immunotherapy as a frontline in combination with the standard of care frontline therapy. There are a few standards of care, but a common one is rituximab plus lenalidomide, or Revlimid. We call it “R squared” (R2). R2 is a very good frontline therapy but leaves a lot of room for improvement. The complete remission rate and the big relevance trial from a couple of years ago with R2 was just under 50%. So, good, but a lot of room for improvement.
The idea here was to bring R2 into combination with epcoritamab and focus on efficacy. The perhaps most exciting result is now the complete remission rate with this triplet was up at 85%. Most patients getting complete remissions. Very exciting, very gratifying for us, and for the patients and their families. And now we have considerable follow-up of this arm 6, median follow -up beyond 22 months. The vast majority of those complete remissions are still in remission. More than 85% of those still in remission. Deep remissions for most patients, and durable remissions for most of these patients. All very exciting results.
The safety of the combination was quite good. Most of the adverse events we saw were attributable to rituximab plus Revlimid, we would say. However, the most obvious epcoritamab-specific adverse event is this thing called cytokine release syndrome (CRS). All of the CRS observed in this study was low-grade, grade 1 and 2. There was no grade 3 or above, so overall pretty well-tolerated. There were other common adverse events like neutropenia, but no febrile neutropenias. [It was] overall a pretty well-tolerated therapy, even though patients here were majority advanced stage, majority 2 through 5, so mostly higher-risk patients—a wonderful result. Very gratifying that we now see we could bring this immunotherapy into frontline in combination with standard of care.
The arm 7 was asking a slightly different question: if we could use maintenance epcoritamab therapy after the completion of standard of care therapy. This was a smaller arm, 20 patients with follicular lymphoma who had mostly had 1 prior line of therapy in partial or complete remission from that prior therapy. We added epcoritamab for up to 2 years afterwards, giving it every 8 weeks.
Overall [it was] pretty well-tolerated. All of the CRS was low-grade, grade 1 and grade 2, and there were about 8 patients here who were in partial remission going into the trial, and all of them converted to complete remission. These remission, almost across the board, were maintained now for more than 22 months on average. A pretty encouraging result, and well-tolerated.
It’s gratifying for us and for the patients and their families that we could bring this novel mechanism of action, immune elimination of cancer cells, into the frontline to see that it is well-tolerated with standard of care and pretty effective. We are now continuing larger randomized trials of epcoritamab plus R^2 as a frontline randomized trial, and as a second line for follicular lymphoma, randomized phase 3 trial there as well Hopefully we'll be able to get these for most of our patients in the near future.
Source:
Lori L, Falchi L, Vermaat J S P, et al. Epcoritamab with rituximab + lenalidomide (R2) in previously untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance in FL: EPCORE NHL‑2 arms 6 and 7. Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract 7014