Brentuximab vedotin as bridging and maintenance therapy in hematopoietic cell transplant in a national access program for relapsed or refractory classical Hodgkin lymphoma patients

Introduction/Background/Significance: Hematopoietic cell transplantation (HCT) is essential for eligible patients with relapsed/refractory classical Hodgkin lymphoma (R/RcHL), but optimal disease control pre-HCT is crucial for success. Brentuximab vedotin (BV), an anti-CD30 antibody-drug conjugate, has shown efficacy as post-HCT maintenance therapy. This study assesses BV as a bridging and post-HCT maintenance therapy within Mexico's Patient Access Program (PAP) for R/RcHL patients.

Materials and Methods/Case Presentation/Objective: We conducted a secondary data retrospective study including patients diagnosed with R/RcHL who were enrolled in the PAP between January 2017 and December 2021. A total of 231 patients were identified, of whom 193 (83.5%) were deemed eligible for HCT by their treating physicians, either for autologous or allogeneic HCT. Variables included demographic data, disease status, prior lines of therapy, BV use (number of doses, indication, sequence relative to HCT), type of transplant (autologous or allogeneic), transplant eligibility and completion, and clinical outcomes such as relapse, death, and survival. Patients were categorized into groups according to whether they received BV as bridging therapy and/or maintenance therapy post-HCT. Outcomes of interest included the rate of HCT completion, incidence of post-HCT relapse and relapse-free survival (RFS), and overall survival (OS).

Results/Description/Main Outcome Measures: Among 193 transplant-eligible patients, 71 (36.8%) underwent HCT: 59 autologous and 12 allogeneic (9 matched related, 3 haploidentical). Two patients had an allo-HCT after relapsing from an auto-HCT. The remaining 122 did not undergo HCT due to lack of access to transplant (n=62), disease progression (n=42), patient refusal (n=6), death (n=3), stem-cell mobilization failure (n=3), among other reasons. BV was used as bridging therapy in 46/193 (23.8%) patients eligible to HCT, of whom 28/46 (60.9%) eventually underwent HCT, compared to 43/147 (29.3%) of patients candidate to HCT who did not receive BV as bridging therapy (p< 0.001). Of the 71 who underwent HCT, 28 received BV as a bridge to HCT, of whom 12 (42.9%) also received BV as post-HCT maintenance therapy. Among the 43 patients who did not receive BV as a bridge to HCT, 17 (39.5%) received BV as maintenance post-HCT. Overall, BV was used as post-HCT maintenance in 29 patients (40.8%, median 12 doses). Post-HCT relapse occurred in 19 patients (median time to relapse: 10.5 months). Relapse occurred in 24.1% (7/29) in the maintenance group vs. 28.6% (12/42) without maintenance (p=0.6780). No significant differences were observed in RFS (p=0.4917) or OS (p=0.3529) by use of BV maintenance therapy. Notably, 41.4% of those receiving maintenance had also received at least one dose of BV as bridging therapy. Thirty-six-month OS rate was higher in HCT vs. non-HCT patients (100% vs 85.9%).

Conclusions: BV use as bridge to HCT may increase the likelihood of undergoing HCT. While post-HCT maintenance with BV did not significantly improve OS or RFS, several factors could explain this result, including prior BV exposure or insufficient power of the study.

Trademarked Items

Brentuximab vedotin

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