Phase 1/Dose Expansion Trial of Brentuximab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Background

Diffuse large B-cell lymphoma (DLBCL) is a prevalent form of non-Hodgkin lymphoma, with a significant portion of patients relapsing or becoming refractory to initial treatments. The study explores the efficacy of combining brentuximab vedotin (BV), a CD30-targeted antibody-drug conjugate, with lenalidomide (Len), an immunomodulator, in treating relapsed or refractory DLBCL.

Methods

Thirty-seven patients with relapsed or refractory DLBCL, ineligible for autologous stem cell transplant, were treated with BV every 21 days and continuous Len for up to 16 cycles. The study aimed to determine the safety, maximum tolerated dose, and efficacy of this combination.

Results

The combination therapy was well-tolerated, with the most common adverse events being neutropenia and thrombocytopenia. The overall response rate was 57%, with a complete response rate of 35%. The median progression-free survival was 10.2 months, and the median overall survival was 14.3 months. Notably, patients with CD30+ DLBCL showed a higher response rate of 73%.

Conclusion

The combination of brentuximab vedotin and lenalidomide presents a promising treatment option for patients with relapsed or refractory DLBCL, especially those ineligible for autologous transplant. The favorable safety profile and efficacy outcomes support further investigation in a Phase 3 trial to confirm these findings and potentially establish a new standard of care for this challenging patient population.