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ASH 2025 | Fixed-duration epcoritamab in older patients with newly diagnosed DLBCL and comorbidities
Umberto Vitolo, MD, Candiolo Cancer Institute, FPO-IRCCS, Turin, Italy, presents the results of the EPCORE DLBCL-3 study (NCT05660967), which evaluated fixed-duration epcoritamab monotherapy in older patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) and comorbidities. Prof. Vitolo highlights that the findings are promising, noting that this chemotherapy-free approach may be a valuable option for patients who are not eligible for standard chemotherapy regimens. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
This is a phase 2 study which an enrolled 66 patients with newly diagnosed diffuse large B-cell lymphoma, elderly people with comorbidities considered not eligible for doxorubicin-containing regimens because of age more than 80 years old or more than 75 years old with comorbidities. 92% of the patients had three or more comorbidities, and they were deemed to be ineligible for doxorubicin because of comorbidities and cardiac comorbidities...
This is a phase 2 study which an enrolled 66 patients with newly diagnosed diffuse large B-cell lymphoma, elderly people with comorbidities considered not eligible for doxorubicin-containing regimens because of age more than 80 years old or more than 75 years old with comorbidities. 92% of the patients had three or more comorbidities, and they were deemed to be ineligible for doxorubicin because of comorbidities and cardiac comorbidities. This type of patient are usually very poor prognosis because they are not a candidate for standard chemotherapy, and the response rate is low and with a short progression-free survival.
In our study, in the first part, patient were randomized to epco monotherapy or epco plus lenalidomide, but based on a careful balance between safety and efficacy, epcoritamab monotherapy was selected for the second part of the study. 66 patients were enrolled in this part with epcoritamab as a single agent that was given for one year with a fixed duration of treatment.
The results were impressive because the overall response rate was 62%, the complete metabolic response was 62%. The progression-free survival at one year is 54% for the patients, the overall survival is 65%. So in this type of patient that are without a standard of care treatment, this could be considered a chemo-free option, a valuable option for these patients. The safety is also manageable. The most frequent was CRS, that was a little bit higher compared to what we usually see in younger patients, but was manageable with very few patients with grade 3. 12 patients had ICANS and it’s important to note that the 12 patients that had ICANS all of them but one resolved, and again this patient had pre-existing neurological impairment. So at the conclusion I would say that this study is the first step to offer to patients not deemed eligible for chemotherapy a chemo-free approach in DLBCL with de novo diagnosis and can offer a potential novel treatment for these patients.
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