The U.S. Food and Drug Administration (FDA) has given the green light to a new combination therapy for adults suffering from specific types of relapsed or hard-to-treat large B-cell lymphomas (LBCL) who are not suitable candidates for stem cell transplants or CAR-T therapy. This innovative treatment consists of brentuximab vedotin (Adcetris), lenalidomide, and rituximab (BV+R2). It specifically targets types of LBCL such as diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL that arises from slower-growing lymphoma.
This approval stems from the phase 3 ECHELON-3 clinical trial, which involved 230 adults facing these conditions. Participants were divided into two groups: one received the BV+R2 combination, while the other was given a placebo along with lenalidomide and rituximab. The trial’s goal was to evaluate overall survival (the length of time patients lived), progression-free survival (the duration without cancer worsening), and response rates to the treatment.
The results indicated that the BV+R2 group had a longer average survival time (13.8 months) compared to the placebo group (8.5 months). Additionally, patients receiving BV+R2 showed improved progression-free survival (4.2 months versus 2.6 months) and a higher overall response rate (64.3% compared to 41.5%).
Common side effects associated with the treatment included fatigue, diarrhea, nerve damage (peripheral neuropathy), rash, and infections such as pneumonia or COVID-19. Some patients faced serious blood-related side effects, including low levels of neutrophils, lymphocytes, platelets, and hemoglobin. Peripheral neuropathy was reported in 27% of patients, occasionally resulting in dose adjustments or discontinuation of brentuximab vedotin.
The recommended dosage of brentuximab vedotin is 1.2 mg/kg (up to 120 mg), administered alongside lenalidomide and rituximab every three weeks until the disease progresses or side effects become intolerable.
This approval represents a significant advancement, as it is the first treatment in its category to demonstrate a survival benefit for patients with advanced LBCL who have previously undergone other therapies.
