Researchers have found that the use of the immunotherapy nivolumab alongside an existing treatment plan can increase survival rates for patients with advanced Hodgkin lymphoma to 92%. This is a significant rise compared to the 83% survival rate seen in patients receiving standard care after two years. The aim of this study was to avoid radiation treatment, which can lead to severe side effects and risk of secondary cancers later in life. Researchers anticipate that using nivolumab will result in lower incidences of breast cancer, infertility, heart disease, and other common complications associated with radiation therapy in the future.
A new treatment that utilizes the immune system to combat cancer has raised the survival rate of patients with advanced Hodgkin lymphoma to an impressive 92%, hinting at a potential new standard for treatment. The results of this groundbreaking clinical trial were published this week in the New England Journal of Medicine.
Hodgkin lymphoma primarily affects younger individuals and is a rare form of cancer related to the blood and immune system, which falls under the broader classification of lymphomas. With this innovative treatment, researchers believe they have identified a way to lessen the long-term adverse effects of therapy, including risks of secondary cancers and heart and lung issues in the future.
“We anticipate a significant decrease in breast cancer cases in this patient demographic over the next 20 to 30 years, as well as reduced instances of infertility and heart disease,” said Jonathan Friedberg, MD, MMSc, director of the Wilmot Cancer Institute at the University of Rochester Medical Center and lead investigator of the study.
Traditional treatment for Hodgkin lymphoma, which often consists of chemotherapy and sometimes radiation therapy, especially in younger patients, has a cure rate exceeding 80%.
“However, the 20% of patients who do not achieve a cure still face a long journey,” Friedberg remarked. “This study aimed to enhance the cure rate while minimizing side effects and lasting toxicities, which is what makes this clinical trial truly groundbreaking.”
Friedberg is the senior researcher and corresponding author for the phase 3 study and chairs the lymphoma committee at the SWOG Cancer Research Network. A large team from SWOG conducted this research as part of the National Cancer Institute (NCI)-supported National Clinical Trials Network.
“This trial exemplifies the strength of collaboration in research,” Friedberg added. “Such work would not have been feasible without the remarkable teamwork of numerous colleagues across the United States and Canada.”
He acknowledged the efforts of Alex Herrera, M.D., chief of the lymphoma division at City of Hope in Los Angeles; senior biostatistician Michael LeBlanc, PhD, and Hongli Li, MS, both from Fred Hutch Cancer Center in Seattle; as well as pediatric oncologists Kara Kelly, MD, at Roswell Park Comprehensive Cancer Center, and Sharon Castellino, MD, MSc, at Winship Cancer Institute of Emory University, who oversaw the study’s recruitment through the Children’s Oncology Group, the largest global organization focused on childhood and adolescent cancer research.
Key findings from the trial, identified as S1826:
- Nearly 1,000 patients participated in this randomized phase 3 trial at various cancer treatment centers and academic institutions throughout the U.S., conducted through the SWOG network. The average age of the patients with Hodgkin lymphoma in this research was 30 years.
- Half of the participants received the standard treatment, which includes chemotherapy and the medication brentuximab vedotin. The other half received the same chemotherapy treatment along with an immunotherapy, nivolumab, which addresses a common genetic mutation found in Hodgkin lymphoma.
- Upon two years of follow-up, 92 percent of patients receiving immunotherapy remained alive without disease progression, compared to 83 percent in the standard treatment group.
- The study was designed to be inclusive, with one-third of participants being pediatric patients aged 12 and older, about 10 percent over 60, and 25 percent from underrepresented groups.
- Typically, young patients with Hodgkin lymphoma have received both chemotherapy and radiation, a treatment that, while effective against cancer, leads to significant side effects that can last a lifetime. In this trial, the decision to forgo radiation therapy aimed to reduce such issues, resulting in fewer side effects among those treated with immunotherapy.
- The trial adopted a unique method by combining younger and older patients in the same study, ensuring they received identical treatments. This uniform treatment approach across age groups serves as a model for other upcoming studies involving adolescents and young adults with cancer, allowing quicker integration of novel cancer therapies into younger populations, according to Friedberg.
Due to the strong preliminary trial results, the NCI decided to halt the study early to facilitate a quicker review by the U.S. Food and Drug Administration. The American Society of Clinical Oncology (ASCO) highlighted these findings in 2023 when there was a year’s worth of follow-up data available. The latest analysis confirmed the initial outcomes.
The FDA will decide if nivolumab should be incorporated into the standard treatment for stage 3 or 4 Hodgkin lymphoma. However, given that nivolumab already has approvals for other uses, Friedberg expects it to swiftly integrate into treatment guidelines and standard care protocols.
This research was supported by funding from the NCI, while Bristol-Myers Squibb, the company that manufactures nivolumab, provided additional support through a cooperative agreement with the NCI.