In a trial that started with patients heavily pretreated for large B-cell lymphoma (LBCL), more than half who achieved a complete response (CR) with the bispecific epcoritamab (Epkinly; Genmab\/AbbVie) remained in remission at 3 years, and 63% were still alive, according to results published early this month.1<\/p>\n
Long-term data from the EPCORE NHL-1 trial were published February 4 in the Annals of Hematology<\/a>.1 An earlier presentation of these data took place during the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California, in December 2024.2<\/p>\n Among patients in the trial who achieved a CR, 53% remained in remission at the time of data cutoff, with the longest CR exceeding 43 months. This occurred despite the fact that 75% of the patients were refractory to at least 2 lines of treatment and 39% had already received chimeric antigen receptor (CAR) T-cell therapy. In addition, of the 19 patients evaluable for measurable residual disease (MRD) assessment, 45% achieved MRD negativity at some point during the study.1<\/p>\n \u201cAn estimated 53% of patients with a CR remained progression free at 3 years, and an esti\u00admated 75% of patients with a CR had not initiated a new anti-lymphoma therapy at 3 years,\u201d investigators wrote.1<\/p>\n EPCORE NHL-1 (NCT03625037<\/a>) is a multicohort, single-arm, phase 1\/2 trial conducted at 54 global sites. It evaluated epcoritamab, a subcutaneous CD3xCD20 bispecific antibody, in 157 patients with relapsed or refractory (R\/R) CD20+ mature B-cell non-Hodgkin lymphoma<\/a>; these included 139 patients with diffuse large B-cell lymphoma (DLBCL). After a step-up dosing, treatment moved from every 2 weeks to every 4 weeks, and patients remained on epcoritamab until disease progression or unacceptable toxicity.1<\/p>\n Data from EPCORE-NHL-1 led to FDA\u2019s accelerated approval of epcoritamab in R\/R DLBCL in May 20233; epcoritamab also received accelerated approval for R\/R follicular lymphoma (FL) in June 2024.4<\/p>\n More recently, in November 2025, the FDA approved epcoritamab in combination with lenalidomide and rituximab, a combination known as R2, to treat FL as early as the first relapse, based on results<\/a> of the phase 3 EPCORE FL-1 trial (NCT05409066).5<\/p>\n According to the study authors, this extended durability suggests the potential for long-term disease-free survival for a subset of patients. \u201cProlonged CR and survival in complete responders, alongside sustained MRD negativity and a manageable safety profile, support epcoritamab monotherapy as an effective therapy with durable outcomes for patients with challenging-to-treat R\/R LBCL,\u201d they wrote.<\/p>\n Other results reported at the 3-mark include:<\/p>\n Patients enrolled had a median age of 64.0 years; 60% were male, 61% had primary refractory disease, and 29% had progressed within 6 months of prior CAR T-cell therapy.The trial\u2019s primary end point was overall response rate (ORR). At the 3-year mark, the ORR was 59%, with a CR rate of 41%; both rates were maintained from prior analyses, \u201cdemonstrating the stability of treatment outcomes over time,\u201d the investigators wrote.As of May 3, 2024, median follow-up was 37.1 months (range, 0.3 to 45.5). Median duration of response was 20.8 months (95% CI, 13.0-32.0).Median duration of CR was 36.1 months (95% CI, 20.2\u2013not reached [NR]), \u201crepresenting one of the longest median durations of complete response for approved bispecific antibodies in this patient population.\u201dMedian progression-free survival for the overall study population was 4.2 months (95% CI, 2.8\u20135.5) with the investigators reporting that \u201cMost patients who remained on epcoritamab beyond 1 year of treatment remained progression free.\u201dAmong the 47 patients who responded for at least 1 year, 11% had disease progression between 1 year and 2 years of treatment; of the remaining 29 who stayed on treatment beyond 2 years, 7% had disease progression after 2 years.The median OS was 18.5 months (95% CI, 11.7\u201327.7) for the overall population and was NR (95% CI, 36.4\u2013NR) for patients with a CR.<\/p>\n Safety. Long-term safety results were consistent with previous reports. Cytokine release syndrome was the most common adverse event (AE), seen in 51% of patients, with no new cases in the extended follow-up. Cases that occurred took place mostly during cycle 1 after the first full dose and were mostly low-grade (grade 1, 32%; grade 2, 16%). Infections were seen in 57% of patients, with grade 1 and 2 infections accounting for 23% and 34%, respectively.1<\/p>\n COVID-19 contributed to infection-related AEs of grade 3 or higher, which were seen in 24% of patients; rates were consistent (3% to 17%) across 12-week intervals up to week 144. Treatment-emergent AEs led to discontinuation in 17% of patients, with COVID-19 being the most common reason. Deaths attributable to AEs occurred in 13% of patients.1<\/p>\n Other results. Epcoritamab is being further investigated as a mono\u00adtherapy and in combination with other treatments in several phase 3 trials. In January 2026, topline results for the phase 3 EPCORE DLBCL-1 trial (NCT04628494) were reported by Genmab and AbbVie. EPCORE DLBCL-1 involves patients with R\/R DLBCL who were treated with subcutaneous epcoritamab vs investigator\u2019s choice chemoimmunotherapy.6<\/p>\n The study showed a 26% improvement in PFS (HR, 0.74; 95% CI, 0.60-0.92), with improvements seen in CR rates, duration of response, and time to next treatment among patients treated with epcoritamab. According to the statement, the trial did not demonstrate a statistically significant improvement in OS (HR, 0.96; 95% CI, 0.77-1.20).<\/p>\n References<\/p>\n Karimi YH, Cheah CY, Clausen MR, et al.\u00a0Efficacy and safety of epcoritamab in relapsed or refractory large B-cell lymphoma: 3-year update from the EPCORE NHL-1 trial.\u00a0Ann Hematol. 2026;105(3):79. doi:10.1007\/s00277-026-06798-4Vose JM,\u00a0Cheah CY,\u00a0Clausen MR,\u00a0et al. 3-Year Update from the EPCORE NHL-1 trial: epcoritamab leads to deep and durable responses in relapsed or refractory large B-cell lymphoma.\u00a0Blood.\u00a02024;144 (suppl 1):4480. doi:10.1182\/blood-2024-198714Epkinly (epcoritamab-bysp) approved by US FDA as the first and only bispecific antibody to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). News release. PRNewswire. May 19, 2023. Accessed February 12, 2026. https:\/\/bit.ly\/3BGQt9j<\/a>FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. FDA. June 26, 2024. Accessed January 24, 2025. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma<\/a>Falci L, Nijland M, Huang H, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. Published online December 7, 2025.\u00a0doi:10.1016\/S0140-6736(25)02360-8Genmab announces topline results for epcoritamab (DuoBody\u00ae CD3xCD20) from phase 3 EPCORE\u00ae DLBCL-1 trial in patients with relapsed\/refractory diffuse large B-cell lymphoma (DLBCL). News release. Genmab. January 16, 2026. Accessed February 12, 2026. https:\/\/ir.genmab.com\/news-releases\/news-release-details\/genmab-announces-topline-results-epcoritamab-duobodyr-cd3xcd20<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"In a trial that started with patients heavily pretreated for large B-cell lymphoma (LBCL), more than half who…\n","protected":false},"author":2,"featured_media":456173,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[5,4],"class_list":{"0":"post-456172","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-nhl","8":"tag-hockey","9":"tag-nhl"},"share_on_mastodon":{"url":"https:\/\/channels.im\/@nhl\/116060276395932118","error":""},"_links":{"self":[{"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/posts\/456172","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/comments?post=456172"}],"version-history":[{"count":0,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/posts\/456172\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/media\/456173"}],"wp:attachment":[{"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/media?parent=456172"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/categories?post=456172"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rawchili.com\/nhl\/wp-json\/wp\/v2\/tags?post=456172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}