Children’s Oncology Group study shows benefit for children and adolescents
with high-risk HL treated with the combination
- Phase 3 trial enrolled 600 children and teens with high-risk Hodgkin lymphoma
- Brentuximab vedotin + standard chemotherapy shown to be safe and effective
- New combination could be used as frontline treatment, research team concludes
CHICAGO, Ill. — New research led by Kara Kelly, MD, of Roswell Park Comprehensive Cancer Center and presented today at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago shows that a combination of brentuximab vedotin (Bv) and standard chemotherapy is safe and more effective than standard chemotherapy in pediatric patients up to age 21 years with newly diagnosed high-risk Hodgkin lymphoma. The findings from a phase 3 National Cancer Institute-supported multicenter Children’s Oncology Group clinical trial (NCT 02166463) are being presented by first author Sharon Castellino, MD, of Emory University and Children’s Healthcare of Atlanta in an oral abstract session today at 2:12 p.m. CDT.
Bv is an antibody-drug conjugate designed to selectively kill tumor cells expressing the CD30 antigen, a marker of Hodgkin lymphoma, while generally sparing healthy cells. The FDA has approved the use of Bv for the treatment of adults with advanced-stage Hodgkin lymphoma.
“We’re sincerely excited about the results from this phase 3 clinical trial conducted at Roswell Park and 150 other treatment centers, which was the first to establish that brentuximab vedotin in combination with chemotherapy is safe and effective in children and adolescents with high-risk Hodgkin lymphoma,” says Dr. Kelly, Chair of the Roswell Park Oishei Children’s Cancer and Blood Disorders Program and the Waldemar J. Kaminski Endowed Chair of Pediatrics at Roswell Park, and the study’s senior author. “The benefits we observed are pronounced enough to support a change in clinical practice.”
In the four-year study, 587 eligible children and adolescents aged 2 to 21 years with newly diagnosed, previously untreated, high-risk Hodgkin lymphoma were randomized to receive five cycles of either Bv combined with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide chemotherapy (Bv-AVE-PC) or standard pediatric dose-intensive regimen of bleomycin-containing chemotherapy consisting of doxorubicin, bleomycin, vincristine, etoposide, cyclophosphamide and prednisone (ABVE-PC).
The dose-intensive Bv-AVE-PC regimen was superior to standard chemotherapy, with a three-year event-free survival rate of 92% compared to 82% — which amounts to an overall risk reduction of 59% — with no increase in toxicity and fewer patients receiving radiation compared to prior pediatric trials for high-risk disease. Rates of disease relapse were lower in patients who received Bv-AVE-PC (7%) than in those who received standard chemotherapy (17%). Researchers found no difference in serious adverse events or rates of myelosuppression or neuropathy between groups.
The researchers concluded that Bv in combination with AVE-PC chemotherapy has superior efficacy to the standard ABVE-PC regimen in pediatric patients up to age 21 years with high-risk Hodgkin lymphoma and could be used as a frontline treatment in this patient population.