David J. Andorsky, MD, on DLBCL and FL: New Data on Use of Subcutaneous Epcoritamab

I am very happy to share with you the interim results from our study of the outpatient administration of Epcoritamab for relapsed and refractory diffused large cell and follicular lymphoma. Epcoritamab as you know is a bispecific antibody for the treatment of B-cell lymphomas. It's currently FDA approved for the treatment of relapsed and refractory diffused large cell lymphoma. One of the major clinical challenges of the use of bispecific antibodies in this space is the phenomenon of the cytokine release syndrome, which is a major toxicity, and as a result, the labels for Epcoritamab and other bispecifics require hospitalization during their first full dose in order to monitor patients for cytokine release syndrome or CRS. This is a major barrier to care. It's often difficult to coordinate with a hospital if the patient's oncologist is not practicing at that hospital or not directly an employee of that hospital. And it also adds cost and inconvenience for the patients. So in this study, we sought to demonstrate the feasibility of outpatient administration exclusively. So patients were recruited who had diffused large B cell lymphoma in the second line and beyond for therapy and follicular lymphoma, the third line and beyond. All patients were educated on CRS and given a wild card with instructions and symptoms to look for. They were instructed to take their temperature three times a day after cycle one day 15, which is the first full dose, and it's known that most of the cytokine release syndrome occurs after that dose. They were required to stay within 30 minutes of the treating institution in case they needed medical help. In addition, patients were pre-medicated with steroids to mitigate the CRS. The report we have this year at ASCO includes 31 patients, and the CRS that we observed was very similar to what was observed in the previous studies. About 25% grade one and 25% grade two after cycle one day 15. Most notably 21 out of 31 patients on the study so far were treated entirely in outpatient setting and were not admitted for any reason. The patients that were admitted, the vast majority were admitted for management of CRS. Most CRS surveillance resolved within 24 to 48 hours, and no patients needed to discontinue from the study because of CRS. Again, in conclusion, we believe this study in the preliminary results demonstrates the feasibility of outpatient administration of Epcoritamab with reflexive rather than preemptive hospitalization. We believe this will expand access to the medication, make it easier for clinicians and patients to obtain, and we hope to present further results including efficacy at a future date.