ORLANDO – The combination of brentuximab vedotin 1.8 mg/kg on day 1 with bendamustin 90 mg/m2 on days 1 and 2 of a 3-week cycle represents a very effective and tolerable outpatient regimen for heavily treated patients with Hodgkin lymphoma and anaplastic large T-cell lymphoma (ALCL).1
Although patients with Hodgkin lymphoma or ALCL who have relapsed or are ineligible to undergo autologous stem cell transplantation (ASCT) are incurable with standard therapies, treatment with brentuximab vedotin has become the preferred approach for these patients.
“Both agents, brentuximab vedotin and bendamustine, have shown activity in relapsed/refractory Hodgkin lymphoma,” said Ahmed Sawas, MD, hematologist/medical oncologist at the Columbia University Medical Center Center for Lymphoid Malignancies in New York, NY, at the 57th American Society of Hematology Annual Meeting.
Because bendamustine has also demonstrated good activity and tolerability in various subtypes of lymphoma, researchers sought to evaluate the efficacy and safety of brentuximab vedotin plus bendamustine for the treatment of patients with relapsed or refractory Hodgkin lymphoma or ALCL.
For the phase 1/2 study, researchers enrolled 42 patients with a median age of 37 to receive an outpatient intravenous infusion of brentuximab vedotin on day 1 in combination with bendamustine on days 1 and 2 of 21-day cycles for up to 6 cycles. Only 1 patient had ALCL.
After the dose-escalation phase, the recommended doses for brentuximab vedotin and bendamustine were 1.8 mg/kg on day 1 and 90 mg/m2 on days 1 and 2, respectively. Patients were followed afterwards for response.
Results showed that the overall response rate was 67% for the 36 evaluable patients, of which 7 patients achieved a complete response and 8 patients had stable disease. Of the 11 patients who had received prior brentuximab vedotin, 2 achieved a complete response, 2 had a partial response, and 3 had stable disease.
Among the 4 patients who had prior bendamustine, 2 patients achieved a partial response and 1 patient had stable disease. In addition, of the 2 patients that had received both brentuximab vedotin and bendamustine as single-agents, 1 achieved a partial response, and the 1 patient with ALCL achieved a partial response.
“Preliminary data in 9 patients showed a median duration of response of 4.4 months (range, 2.3 – 10.3), and 2 patients underwent ASCT; their data were censored,” Dr Sawas noted.
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In regard to safety, the most common adverse events associated with combination therapy were neutropenia, anemia thrombocytopenia, and lung infections. “The safety profile is manageable,” Dr Sawas said.
“In this heavily pretreated population of HL and ALCL, the combination of brentuximab vedotin and bendamustine represents a very active and tolerable regimen,” Dr Sawas concluded.
The phase 2 portion of this study is now accruing an additional 18 patients.
- Sawas A, Connors JM, Kuruvilla JG, et al. The combination of brentuximab vedotin (Bv) and bendamustine (B) demonstrates marked activity in heavily treated patients with relapsed or refractory Hodgkin lymphoma (HL) and anaplastic large T-cell lymphoma (ALCL): Results of an international multi center phase I/II experience. Oral presentation at: 57th American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2015; Orlando, FL.