AbbVie’s bispecific antibody therapy Epkinly (epcoritamab) has shown promising results in maintaining long-term complete remission (CR) for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). CR signifies the absence of detectable cancer following treatment.
According to industry reports on Thursday, AbbVie presented a three-year follow-up analysis of the EPCORE NHL-1 clinical trial at the recent American Society of Clinical Oncology (ASCO) annual meeting in Chicago. The findings revealed that 96% of patients who achieved CR two years after Epkinly treatment continued to maintain this status at the three-year mark.
The follow-up analysis focused on 32 patients from the NHL-1 study who had maintained a CR for over two years after receiving Epkinly monotherapy. Of these, 59% are still undergoing treatment, while the remaining 12% discontinued therapy for reasons unrelated to their disease but still maintained CR. Some patients have sustained CR for over 43 months.
Notably, patients who maintained CR for more than two years after Epkinly treatment had relatively lower initial tumor burdens. Only 19% of the CR-maintaining group had tumors larger than 7 cm in diameter at the start of treatment, compared to 34% in the group that did not maintain CR. Significant differences were also observed in blood levels of LDH and ferritin.
Interestingly, previous CAR-T treatment experiences were similar between the two groups, at 38% and 39%, respectively. This suggests little correlation between CR duration and prior CAR-T therapy. Instead, the extent of cancer spread before treatment may be a crucial factor in Epkinly’s long-term effectiveness.
The median follow-up period was 37 months (32-46 months), with the median duration of CR (mDOCR) not yet reached. The CR maintenance rate at three years stands at approximately 96%, further validating Epkinly’s sustained and profound anti-cancer effects.
This year’s ASCO meeting also unveiled early results from the EPCORE NHL-4 Phase 1b/2 trial, focusing on Chinese patients with refractory diffuse large B-cell lymphoma (DLBCL). In this study, 42 heavily pretreated patients received Epkinly monotherapy, resulting in an objective response rate (ORR) of 64.9% and a complete remission rate (CRR) of 37.8%.
The median progression-free survival (PFS) was 4.5 months, while the median duration of response (DoR) and overall survival (OS) have not yet been reached. Cytokine release syndrome (CRS) occurred in 84% of cases, mostly mild, and no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. One case of tumor lysis syndrome resolved without interruption of treatment.
Epkinly is emerging as a promising alternative for patients ineligible for or unsuitable for existing CAR-T treatments. This latest data provides compelling evidence supporting Epkinly’s potential as a non-invasive and well-tolerated monotherapy for R/R LBCL.