Blinatumomab Consolidation After Auto-SCT Yields Safety, Tolerability Among Patients With Relapsed DLBCL

Consolidation with blinatumomab, a CD3/CD19 bispecific T-cell engager, after autologous stem cell transplant (auto-SCT) demonstrated safety and tolerability among patients with relapsed diffuse large b-cell lymphoma (DLBCL), according to a recent pilot study, which also noted that a larger randomized trial is needed to confirm efficacy. 

This preliminary study included 14 patients with DLBCL or transformed follicular lymphoma (FL). All patients underwent a standard-of-care auto-SCT with carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning, which was then followed by 1 cycle (4 weeks continuous infusion) of blinatumomab consolidation starting at day 42 after auto-SCT. The primary end point was feasibility and tolerability, which was defined as the proportion of patients who completed a full course of blinatumomab. Secondary end points included progression free survival (PFS), overall survival (OS), and complete response (CR) rates.

Eligible patients had received a median of 2 prior lines of therapy, and all received previous anti-CD20 directed therapy and anthracycline-based therapy. In this study, 4 patients achieved a partial response (PR) and 10 patients achieved a CR to salvage chemotherapy as determined by computed tomography (CT) or positron emission tomography (PET)/CT before auto-SCT.

All patients treated with blinatumomab after auto-SCT completed a single 28-day cycle of blinatumomab administered by continuous IV infusion. Blinatumomab started 42 ± 8 days after auto-SCT for all patients. After 3 years post auto-SCT, 4 patients remained in a CR, 10 patients had progressive disease (PD), and 3 of those with PD had died. The median PFS was 18 months (95% confidence interval [CI], 6 months to not reached), and median OS was not reached. The 3-year PFS and OS were 28.6% (95% CI, 12.5 to 65.4) and 78.6% (95% CI, 59.8 to 100), respectively.

Adverse events included 5 patients who developed grade 1 cytokine release syndrome (CRS), with no grade ≥2 CRS. Immune effector cell–associated neurotoxicity syndrome was not observed. Additionally, 6 patients developed transient tremor, and 1 patient developed grade 3 ataxia. Study authors noted that all events completely resolved.

Armin Ghobadi, MD, Washington University School of Medicine, St. Louis, Missouri, and colleagues concluded, “Those who relapse after second line CAR T-cell therapy are eligible for innovative salvage therapies followed by auto-SCT and, if still CD19+, may benefit from strategies such as blinatumomab consolidation.”

“Strategies to increase the CD8:CD4 ratio and use additional cycles of consolidation in a larger randomized trial are needed to confirm the efficacy of consolidation with blinatumomab after auto-SCT,” they added. 

Source:

Ghobadi A, Foley N, Cohen J, et al. Blinatumomab consolidation post–autologous stem cell transplantation in patients with diffuse large B-cell lymphoma. Blood Adv (2024) 8 (3): 513–522. doi: 10.1182/bloodadvances.2023011130