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Brentuximab vedotin, ibrutinib combination appears effective for Hodgkin lymphoma
ATLANTA — A combination of brentuximab vedotin with ibrutinib appeared tolerable and safe among patients with relapsed or refractory Hodgkin lymphoma, according to results from a phase 2 clinical trial presented at the ASH Annual Meeting and Exposition.
“We continue to gain more information about the safety of combining brentuximab vedotin with other medications, and this is a step toward developing safe combinations of these new antilymphoma therapies for Hodgkin lymphoma,” Alex Herrera, MD, assistant professor in the department of hematology and hematopoietic cell transplantation at City of Hope, told HemOnc Today.
Brentuximab vedotin as a single agent has previously demonstrated a favorable safety profile and has resulted in a 75% objective response rate among patients with relapsed or refractory Hodgkin lymphoma after autologous stem cell transplantation. However, complete response rate was 34%.
“Not all patients benefit from the medication, and less than half will have a complete remission, so there is clearly room for improvement,” Herrera said.
Herrera and colleagues conducted the prospective, multicenter phase 2 trial with a three-patient lead-in cohort among patients with relapsed/refractory Hodgkin lymphoma to assess the safety and efficacy of brentuximab vedotin in combination with ibrutinib (Imbruvica; Pharmacyclics, Janssen).
All patients included in the trial had to be aged 15 years or older and had to have a proven biopsy.
Patients received 1.8 mg/kg of brentuximab vedotin intravenously every 3 weeks and 560 mg of ibrutinib administered orally each day. The three patients within the lead-in cohort received 420 mg of ibrutinib.
Complete response rate served as the primary endpoint. Toxicities, duration of response and overall response rate served as secondary endpoints.
Sixteen patients (median age, 33 years; range, 17-69; 56% male) of 39 had been accrued at the time of presentation, all of whom were evaluable for toxicity assessment. Thirteen patients were evaluable for efficacy; researchers excluded the three lead-in patients.
The overall best response — complete response plus partial response — was 69%; complete response was 46%.
The stable disease rate was 31%, and the researchers did not observe any progressive disease.
One patient refractory to prior brentuximab vedotin treatment achieved a partial response. An additional patient who had a partial response to brentuximab vedotin achieved a complete response with the combination therapy.
The patients did not report any grade 4 adverse events. Grade 3 treatment-related toxicities included neutropenia (n = 2) and hypokalemia (n = 1).
Grade 1 and grade 2 adverse events that occurred in more than 20% of patients included diarrhea (n = 8), nausea (n = 6) and fatigue (n = 5).
“Although the ORR of 69% may be similar to brentuximab alone, the complete response of 46% and disease control rate of 100% appears promising,” the researchers wrote. – by Ryan McDonald
Reference:
Chen RW, et al. Abstract 738. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta.
Disclosures: Herrera reports consultant roles with Bristol-Myers Squibb, Genentech, Merck and Pharmacyclics, as well as research funding from Seattle Genetics.