An immune checkpoint inhibitor, nivolumab, plus chemotherapy significantly reduced the risk of disease progression and disease-related death compared with standard treatment with the CD30-targeted drug brentuximab plus chemotherapy in paediatric and adult patients with previously untreated stage III or IV Hodgkin lymphoma.

The results of the clinical trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

With a median follow-up of 12.1 months, there was a 52% reduction in the risk of disease-related death with nivolumab vs. brentuximab.

The one-year progression-free survival (PFS) with nivolumab was 94% vs. 86% for brentuximab.

There were 11 deaths (7 due to adverse events) with brentuximab vs. 4 with nivolumab (3 due to adverse events).

“Traditionally, adults and children with advanced Hodgkin lymphoma in the U.S. have been treated with different chemotherapy regimens and the majority of children also receive radiation treatment whereas the use of radiation has been uncommon in adult patients,” said Alex Francisco Herrera, MD, lead author and a haematologist at City of Hope in Duarte, CA. “As part of the design and planning of our trial, adult and paediatric cooperative groups met and arrived at a consensus on both the control and experimental regimens, with the goal of harmonising the treatment of Hodgkin lymphoma across all ages, which is a truly unique outcome.”

“This trial was an unprecedented effort across all North American clinical trial cooperative groups to improve the cure rate in advanced stage Hodgkin lymphoma and harmonise treatment approaches between paediatric and adult patients. The collaborations across adult and paediatric groups helped pave the way for a new standard of care that is better tolerated and results in a higher proportion of patients with durable remissions,” said ASCO Expert Oreofe Odejide, MD, ASCO Expert.

SWOG S1826 was a randomised, phase III trial of advanced Hodgkin lymphoma.

The study enrolled 976 people 12 years of age or older who had not received previous treatment for the disease.

Patients were randomly assigned to receive either nivolumab, an FDA-approved PD-1 immune checkpoint inhibitor or brentuximab vedotin, an FDA-approved antibody-drug conjugate directed against tumour necrosis factor receptor CD30.

An estimated 8,830 new cases (4,850 men and 3,980 women) of Hodgkin lymphoma will be diagnosed in the US in 2023. An estimated 900 deaths (540 men and 360 women) will occur in 2023. The current five-year survival rate for advanced disease is 83%

About one-quarter of people with Hodgkin lymphoma do not benefit from therapy. Some newer therapies can be fairly aggressive and toxic for the majority of patients, especially those over age 60. 

Treatment with nivolumab in this trial had limited adverse events due to the immunotherapy.

The most common side effects were typical of combination chemotherapies, including low blood cell counts and gastrointestinal toxicities, such as nausea. Immune-related adverse events were infrequent.

Longer follow-up is needed to assess overall survival and other patient-related outcomes such as quality of life.

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Source: ASCO