Epcoritamab-bysp (Epkinly) plus lenalidomide (Revlimid) generated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs rituximab (Rituxan) plus gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who had received at least 1 prior line of therapy, meeting the primary end point of the phase 3 EPCORE DLBCL-4 trial (NCT06508658).1
The chemotherapy-free regimen reduced the risk of disease progression or death by 60% (HR, 0.40; 95% CI, 0.30-0.55; P < .0001) and 56% (HR, 0.44; 95% CI, 0.33-0.60; P < .0001), based on the censoring rules applied in the United States (US) and outside the US, respectively.
In a news release, AbbVie reported that the safety profile of epcoritamab plus lenalidomide was consistent with the known safety profiles of the individual agents.
"Despite recent advances, there remains a critical need for innovative therapies to improve outcomes for those battling DLBCL, an aggressive and often difficult-to-treat cancer," Daejin Abidoye, MD, vice president, therapeutic area head, oncology, solid tumor and hematology, at AbbVie, stated in a news release. "Today's encouraging topline results highlight the potential of epcoritamab, a fixed-treatment therapy, in combination with lenalidomide, as a meaningful treatment option after initial disease progression."
Epcoritamab
EPCORE DLBCL-4 was a global, multicenter, open-label, randomized phase 3 trial evaluating epcoritamab plus lenalidomide vs R-GemOx in patients at least 18 years of age with R/R large B-cell lymphoma, including DLBCL not otherwise specified; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; grade 3B follicular lymphoma; T-cell/histiocyte-rich large B-cell lymphoma; and EBV-positive DLBCL. CD20-positive disease was required for patients with DLBCL, and patients needed to have received at least 1 prior line of systemic antineoplastic therapy, including an anti-CD20 monoclonal antibody–containing regimen with chemotherapy.3 Patients also needed to meet 1 of the following criteria: progression or relapse after autologous stem cell transplantation (ASCT); not candidates for or refusal of ASCT; ineligible for or unable to receive CAR T-cell therapy.
Enrolled patients were randomly assigned to subcutaneous epcoritamab plus oral lenalidomide, intravenous R-GemOx, or epcoritamab monotherapy.
Patients in the experimental combination arm received subcutaneous epcoritamab once weekly during cycles 1 through 3 and once every 4 weeks during cycles 4 through 12, plus oral lenalidomide at 25 mg per day on days 1 through 21, for a total of twelve 28-day cycles.1 Patients in the comparator arm received intravenous R-GemOx for up to four 28-day cycles.
The primary end point was PFS by independent review committee assessment per Lugano 2014 criteria for the epcoritamab/lenalidomide arm vs the R-GemOx arm. Secondary end points included complete response rate, overall survival, and minimal residual disease negativity rate.3
Detailed efficacy and safety data, including findings for secondary end points, were not disclosed in the topline announcement.1 Data from EPCORE DLBCL-4 will be shared with global regulatory authorities to discuss next steps, and findings will be submitted for presentation at a future medical meeting.
