The combination of epcoritamab, a subcutaneously injected bispecific antibody targeting CD-CD20, and R-Dhax/C, a salvage immunochemotherapy treatment, yielded high overall response rates (ORR) and complete metabolic response (CMR) rates, among patients with relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL), according to the findings from an updated phase 1/2 trial. 

At the 2022 ASH Annual Meeting and Exposition in New Orleans, Louisiana, Pau Abrisqueta, MD, PhD, Hospital Universitari Vall d’Hebron, Spain, presented this data from an updated phase 1/2 study.

“For patients with relapsed or refractory diffuse large B-cell lymphoma who are eligible for autologous stem cell transplant (ASCT), salvage immunochemotherapy, such as rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin (R-DHAX/C), followed by consolidation with high-dose therapy (HDT) and ASCT, is part of the standard of care,” Dr. Abrisqueta and colleagues wrote, “However, this treatment plan is unsuccessful in more than half of patients. Novel treatment options are needed to achieve improved responses and more favorable long-term outcomes.”

29 patients who were eligible for high- dose therapy autologous stem cell transplant (HDT-ASCT) and had R/R DLBCL participated in this study, and 26 of them were evaluable for response on June 10, 2022 (the data cutoff point). The median age was 58 with a range of 28 to 75. 72% of patients had received 1 prior line of therapy; 28% had received 2 or 3 prior therapies; 34% had transformed disease; 66% had primary refractory disease; 59% were unresponsive to their last line of therapy. The median follow up was 9.2 months with a range of 1.7 to 14.2 months. 

R-Dhax-C and subcutaneous epcoritamab were administered as treatment to patients for 21-day cycles. Patients received this combination for the first 3 cycles. If HDT-ASCT was deferred, they could continue with epcoritamab monotherapy until disease progression or toxicity. 

Among common treatment-emergent adverse events, the most common were thrombocytopenia (69%), anemia (45%), CRS (41%), neutropenia (41%), nausea (34%), and fatigue (28%). No TEAEs were fatal. All CRS events were of low grade (grade 1 in 31% of patients and grade 2 in 10% of patients), occurred primarily after the first full dose, and were resolved in a median resolution time of 2 days with a range of 1 to 8 days.  

58% of patients proceeded to HDT-ASCT (n=15), and 100% of them had an ORR with the combination therapy (n=15), with 80% achieving a CMR and 20% achieving a PMR. Among the entire response-evaluable group, the ORR was 85% (n=22/26) with 65% achieving a CMR (n=17/26) and 19% achieving a PMR (n=5/26). 

As endpoints were met and no safety precautions were observed, Dr. Abrisqueta et al concluded, “epcoritamab is well suited for salvage combination therapy.” 

Source: 

Abrisqueta P,  Cordoba R, Falchi L, et al. Subcutaneous Epcoritamab + R-Dhax/C in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Eligible for Autologous Stem Cell Transplant: Updated Phase 1/2 Results. Presented at ASH Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA. Abstract 443.