Subcutaneous epcoritamab plus salvage chemoimmunotherapy with rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin (R-DHAX/C) demonstrated manageable safety in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) eligible for autologous hematopoietic stem cell transplant (autoHSCT), according to preliminary results from a phase 1/2 trial presented at the 2022 ASCO Annual Meeting.

“Current standard of care for patients with [relapsed/refractory] DLBCL eligible for [autoHSCT] includes salvage immunochemotherapy, followed by consolidation with high-dose therapy and [autoHSCT]. However, salvage therapy fails in many patients, and novel treatment options are needed to improve response and long-term outcomes,” wrote Pau Abrisqueta, MD, Vall d'Hebron University Hospital, Barcelona, Spain, and colleagues.

“Epcoritamab, a bispecific antibody targeting CD3 on T cells and CD20 on B cells, had a manageable safety profile and meaningful single-agent antitumor activity in patients with heavily pretreated B-cell non-Hodgkin lymphoma in the dose-escalation part of the EPCORE NHL-1 trial,” they explained.

At the 2022 ASCO Annual Meeting, Dr Abrisquesta presented initial results from arm 4 of the EPCORE NHL-2 phase 1/2 trial, which is exploring epcoritamab plus R-DHAX/C in adult patients with relapsed/refractory CD20-positive DLBCL who were eligible for high-dose therapy and autoHSCT. In the event high-dose therpay and transplant was postponed, patients were able to continue epcoritamab monotherapy until disease progression or unacceptable toxicity.

A total of 27 patients were enrolled and received epcoritamab plus R-DHAX/C as of January 26, 2022. Of these patients, 74% received 1 prior line of therapy and 26% received 2 to 3 prior therapies; 3 pts received prior CAR-T therapy.

The most common treatment–emergent adverse events (AEs) of any grade were thrombocytopenia (67%), neutropenia (48%), infections (37%), nausea (37%), and anemia (33%). Cytokine release syndrome (CRS) occurred in 8 (30%) patients and were all of grade 1 or 2. Immune effector cell-associated neurotoxicity syndrome occurred in 1 patient and was of grade 2. CRS events occurred early in treatment and the median time to resolution was 2 days.

Of the 27 patients on the trial, 23 were evaluable and 11 underwent autoHSCT. The overall response rate (ORR) prior to transplant was 100% (82% complete metabolic response; 18% partial metabolic response).

A total of 12 patients had postponed or canceled high-dose therapy and autoHSCT and continued epcoritamab monotherapy. Of these patients, 5 (42%) had complete metabolic response and 3 (25%) had partial metabolic response.

The complete metabolic response and partial metabolic response rates for the entire evaluable population were 61% (n = 14) and 22% (n = 5), respectively. At the time of data cutoff, 70% of patients in complete metabolic response had received autoHSCT or continued epcoritamab monotherapy.

“Subcutaneous epcoritamab in combination with R-DHAX/C in pts with [relapsed/refractory] DLBCL had a manageable safety profile,” concluded Dr Abrisqueta and colleagues.

Source:

Abrisqueta P, Falchi L, Phillips TJ, et al. Subcutaneous epcoritamab + R-DHAX/C in patients (pts) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) eligible for autologous stem cell transplant (ASCT): Preliminary phase 1/2 results. Presented at: ASCO Annual Meeting; June 3-7, 2022. Chicago, IL, and virtual. Abstract 7528.