Based on results from the phase 3 AHOD1331 trial, the FDA has approved brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients with high-risk classical Hodgkin lymphoma.
The FDA has granted approval to the combination of brentuximab vedotin (Adcetris) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC) in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.1
This approval is supported by findings from the phase 3 AHOD1331 trial in which evaluated the combination in this patient population. Findings revealed that adding the antibody-drug conjugate (ADC) to AVE-PC significantly improved event-free survival (EFS) compared with the standard-of-care treatment with ABVE-PC.
In the investigative arm, patients experienced a reduction in the risk of disease progression or relapse, second cancer, or death of 59% (HR, 0.41; 95% CI, 0.25-0.67; P =.0002).
“[Brentuximab vedotin] is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical Hodgkin lymphoma,” said Marjorie Green, MD, senior vice president and head of late-stage development at Seagen Inc, in the press release. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval.”
The multicenter, randomized, open-label, phase 3 AHOD1331 trial was conducted by the Children's Oncology Group and sponsored by the National Cancer Institute. The study is the largest to be performed in pediatric patients with newly diagnosed, high-risk Hodgkin lymphoma.
A total of 587 patients were enrolled in the trial, ranging between the ages of 2 years to 21 years old. Enrollment in the trial was open to patients who had previously untreated Hodgkin lymphoma with stage IIB and bulky disease, stage IIIB disease, stage IVA disease, or stage IVB disease.2
Investigators randomly assigned patients to receive 5 cycles of either standard dose-intensive chemotherapy ABVE-PC or brentuximab vedotin plus AVE-PC every 21 days with granulocyte colony-stimulating factor support.
The primary end point of the trial was EFS with secondary end points including proportion of patients with early response and proportion of patients experiencing grade 3+ peripheral neuropathy. Other exploratory end points consisted of Childhood International Prognostic Score (CHIPS) score, the dose of radiation received by normal tissues following chemotherapy on either arm, efficacy of involved site radiotherapy, risk of relapse, and pharmacokinetics.