David Andorsky, MD, Rocky Mountain Cancer Centers, Boulder, Colorado, shares expert insight into updated data from the phase 2 EPCORE NHL-6 trial.

The study revealed that subcutaneous epcoritamab demonstrated efficacy among patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the outpatient setting. These results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Enrollment in this study is ongoing, Andorsky and coauthors noted in their abstract, and additional data based on C1 optimization, including potential benefit from inclusion of hydration and dexamethasone, will be presented at a future date.

Transcript:

My name is Dr. David Andorsky. I'm with the Sarah Cannon Research Institute, and I practice medical oncology and hematology at the Rocky Mountain Cancer Centers in Boulder, Colorado. I'm very excited here to be at [the American Society of Clinical Oncology] (ASCO) [meeting] in 2024 to share with you some of the findings from our research regarding the outpatient administration of epcoritamab.

Epcoritamab, as many of your viewers may know, is a bispecific antibody for the treatment of lymphoma. It is 1 arm that binds to CD20, which is a marker on B-cells and lymphoma cells, and the other arm binds to CD3, which engages T-cells and activates an endogenous host immune response.

This is a very exciting area in oncology research, particularly in the hematology space, and epcoritamab is already approved for treatment of diffuse large B-cell lymphoma in the 3^rd line and beyond. Now one of the major barriers to the widespread adoption of the bispecific antibodies is the cytokine release syndrome, which is a well-known side effect that can be very serious for some patients and requires a fair amount of monitoring.

[With] epcoritamab, along with many other bispecific antibodies, the FDA label requires patients to be admitted to the hospital for observation and management of cytokine release syndrome (CRS). This, however, creates a lot of barriers to care. Some patients are not being seen at a cancer center that's part of a hospital, so it's sometimes difficult to get them in in a timely fashion. Also, patients just don't like being in the hospital, and it also drives up cost.

We looked at whether epcoritamab could be given entirely in the outpatient setting, and that CRS could be managed there, as many side effects from oncologic treatments are, such as febrile neutropenia. The study looked at both patients with diffuse large cell lymphoma, 2^nd line to be on, and follicular lymphoma, 3^rd line to be on, and we report on results from the 31 patients that we've recruited to study so far. What we found was that outpatient administration was very feasible.

We had a very structured protocol for how the patients were to be managed. Patients were educated about the incidence of CRS, and they received a wild card with instructions. We know that for epcoritamab, most of the CRS occurs after cycle 1, day 15, which is the first full dose. We told patients to check their temperature at home 3 times a day to monitor for fever, which is often one of the first signs of CRS. We also required that they be within 30 minutes of their treating institutions so they could get medical care quickly if needed.

We also premedicated the patient with steroids to mitigate the CRS. What we found in summary was that 21 of 31 patients were treated entirely [in an] outpatient setting with no need for admission for any reason, including for CRS. The CRS was entirely grade 1 and grade 2. It was about 25% in both categories. It appeared very similar to the previous studies of epcoritamab in terms of severity and time to resolution of the CRS. No patients had to come off study because of the incidence of CRS.

In conclusion, we think these results are very promising that epcoritamab and probably other bispecifics can be given safely in the outpatient setting, which we hope will open access to them and make it easier for patients to receive this revolutionary therapy. Thank you for your attention.

Source:

Andorsky D, Boccia R, Lash B, et al. 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. Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract 7029