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Epcoritamab displayed a significant PFS benefit vs chemotherapy in relapsed/refractory DLBCL.
The T-cell engaging bispecific antibody epcoritamab-bysp (Epkinly) led to a progression-free survival (PFS) benefit when compared with investigator’s choice of chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to topline data from the phase 3 EPCORE DLBCL-1 trial (NCT04628494).1
Patients who received epcoritamab monotherapy experienced a 26% reduction in the risk of disease progression or death compared with those treated with chemotherapy (HR, 0.74; 95% CI, 0.60-0.92). The HR for overall survival (OS) was (HR, 0.96; 95% CI, 0.77-1.20), which did not reach statistical significance. Epcoritamab monotherapy also displayed improvements in complete response (CR) rate, duration of response (DOR), and time to next treatment (TTNT) vs chemotherapy.
“The EPCORE DLBCL-1 trial is the first phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL,” Jan van de Winkel, PhD, the chief executive officer of Genmab, stated in a news release. “The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options. Together with our partner, AbbVie, we remain deeply committed to advancing the development of epcoritamab as a potential core therapy across a broad range of B-cell malignancies.”
EPCORE DLBCL-1 enrolled 483 adult patients with relapsed/refractory DLBCL who received at least 1 prior line of therapy who were ineligible for high-dose chemotherapy and autologous stem cell transplant; most patients received at least 2 prior lines of therapy (73%).1,3 Other key eligibility criteria included an ECOG performance status of 0 to 2, detectable disease by PET scan and measurable disease per CT scan or MRI, acceptable renal and live function, and a life expectancy exceeding 2 months on standard-of-care therapy.3
Eligible patients were randomly assigned to receive epcoritamab or investigator’s choice of chemotherapy with rituximab plus gemcitabine and oxaliplatin or bendamustine in combination with rituximab. Epcoritamab was given in 28-day cycles until any discontinuation criteria were met. Rituximab plus gemcitabine and oxaliplatin was administered in 28-day cycles until the completion of the maximum number of cycles of any of the discontinuation criteria were met. Patients received bendamustine plus rituximab in 21-day cycles until the completion of the maximum number of cycles of any of the discontinuation criteria were met.
The primary end point was OS. Secondary end points included PFS, overall response rate, CR rate, DOR, time to response, minimal residual disease (MRD) negative status, rate of MRD negativity, TTNT, adverse effects (AEs), dose interruptions and delays, number of patients with an anti-epcoritamab antibody response, and changes from baseline in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma scale.
Topline safety data from EPCORE DLBCL-1 revealed that the AEs that were reported appeared to be consistent with the known safety profile of epcoritamab.1 Additional analysis of the study data is ongoing and will factor in the potential effects of various factors including COVID-19 and the increasing availability of novel anti-lymphoma therapies. Full results from the study will be submitted for presentation at a future medical meeting and Genmab and AbbVie plan to engage with global regulatory authorities to discuss next steps.
Further data from EPCORE DLBCL-1 and the phase 3 EPCORE DLBCL-2 trial (NCT05578976) are expected in 2026, according to Genmab. EPCORE DLBCL-2 is examining epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone for the first-line treatment of patients with DLBCL. Moreover, epcoritamab plus lenalidomide is being compared with chemo-immunotherapy for the treatment of patients with relapsed/refractory DLBCL in the phase 3 EPCORE DLBCL-4 study (NCT06508658).
