888MO - Effectiveness of brentuximab vedotin in relapsed/refractory classic Hodgkin lymphoma: A systematic review and meta-analysis

Background

Brentuximab vedotin (BV), an anti-CD30 antibody drug conjugate, was shown to be effective and well-tolerated in relapsed/refractory classic Hodgkin lymphoma (RRcHL) according to a pivotal phase II trial. This study aimed to assess the effectiveness of BV in RRcHL in the real-world.

Methods

Systematic review of observational studies and meta-analysis based on literature (MEDLINE, Embase, Web of Science), pragmatic searches and snowballing (01/01/2010 – 06/02/2020). Data of interest were patterns of BV use, treatment responses, progression-free survival (PFS), overall survival (OS), and adverse events. Statistical heterogeneity assessed through I² statistics. Estimates pooled using a random effects model. Primary analysis included only studies of good methodological quality. Publication bias was assessed by a funnel plot. Sensitivity analyses included studies of moderate quality and estimates reported in abstracts.

Results

The literature search yielded 2,460 references and pragmatic searches found 21 additional ones. Upon abstract screening and in-depth review, eligibility was confirmed for 32 sources. In 26 sources, the dosing regimen of BV in RRcHL was 1.8 mg/kg every 3 weeks. Median number of cycles administered ranged from 4 to 8, uniformly distributed across studies. In real-world environment, the overall response rate (ORR) to BV based on the revised response criteria for malignant lymphoma ranged from 46.6% to 84.0% (28 sources) with 21.1% to 45.8% patients achieving complete response (26 sources). After 4 cycles, pooled estimate of ORR was 62.6% (95% confidence interval [CI]: 56.0 - 68.9; I² = 9.5%) while after 4-6 cycles, it was 66.7% (95% CI: 58.5 - 74.5; I² = 43.9%). Similar results were found in sensitivity analyses. The 1-year, 2-year and 5-year PFS ranged from 52.1% to 63.2% (2 sources), 45.2% to 56.2% (3 sources) and 31.9% to 33.0% (2 sources), respectively. The 1-year, 2-year and 5-year OS ranged from 68.2% to 82.7% (6 sources), 58.0% to 81.9% (7 sources) and 58.0% to 62.0% (2 sources), respectively.

Conclusions

The present study corroborates the effectiveness of BV in RRcHL patients managed in the real-world setting by showing results which are consistent with those of the pivotal phase II trial.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Takeda Pharmaceuticals.

Funding

Takeda Pharmaceuticals.

Disclosure

B. von Tresckow: Advisory/Consultancy, Personal fees: Amgen; Advisory/Consultancy, Personal fees: Pfizer; Advisory/Consultancy, Personal fees and Non-financial support: MSD; Advisory/Consultancy, Personal fees: Gilead; Advisory/Consultancy, Personal fees: Roche; Advisory/Consultancy, Personal fees and Non-financial support: Takeda pharmaceuticals; Research grant/Funding (self), Non-financial support: Novartis. A. Bergamasco, G. Castillon, T. Arredondo-Bisono, T. Cristarella, Y. Moride: Research grant/Funding (institution): Takeda Pharmaceuticals. F. Trinchese. F. Gavini, N. Bent-Ennakhil, A. Zomas: Full/Part-time employment: Takeda Pharmaceuticals. W.J. Plattel: Advisory/Consultancy: Takeda Pharmaceuticals; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD.