Nivolumab added to AVD chemotherapy expected to become new
standard for initial treatment for advanced stage disease in
adolescents and adults, based on trial data to be presented at 2023
American Society of Clinical Oncology (ASCO) Annual Meeting Plenary
Session
LOS
ANGELES and PORTLAND,
Ore., June 4, 2023 /PRNewswire/ -- A Phase 3
trial has demonstrated that patients with advanced Stage (3 or 4)
classic Hodgkin lymphoma who underwent initial treatment with
nivolumab, a PD-1 checkpoint inhibitor, and AVD chemotherapy
(N-AVD) had a significantly lower risk of their cancer getting
worse than patients treated with brentuximab vedotin, a monoclonal
antibody, and AVD (BV-AVD) a year after starting treatment.
SWOG Cancer Research Network trial, led by
City of Hope researcher, shows potential new therapy for a
lymphoma
Ninety-four percent of adolescent and adult patients in the
N-AVD group had progression-free survival compared with 86% in the
BV-AVD arm. N-AVD was also well-tolerated as there were few serious
immune-related side effects in the S1826 trial. The median
follow-up was 12.1 months.
These late-breaking findings will be presented by City of Hope's
Alex Herrera, M.D., at ASCO's 2023
Plenary Session, June 4, at
2:53 p.m. CT in Hall B1 and will be
featured in the official ASCO press program.
Lead investigator on the study, Herrera is chief of the Division
of Lymphoma at City of Hope, one of the largest cancer research and
treatment organizations in the United
States, and is an investigator with the SWOG Cancer Research
Network, a clinical trials group funded by the National Cancer
Institute (NCI), part of the National Institutes of Health.
"The results are remarkable. The combination of nivolumab and
chemotherapy is potent and safe in patients with Stage 3 or 4
classic Hodgkin lymphoma as an initial treatment," said Herrera,
"The therapy is poised to be a standard for treatment of advanced
Hodgkin lymphoma. This is indeed great news for patients with this
cancer as there is another effective and safe treatment option for
them."
Georgie Garabet, 43, of
Glendora, California, was one of
the patients who participated in the trial. When Garabet began to
feel sick in early 2020, he was a 40-year-old father of two
children under the age of 3. His symptoms included uncontrollable
itching all over his body and severe weight loss. After a few trips
to emergency rooms and to his primary care doctor, he was
eventually diagnosed with Stage 3 Hodgkin lymphoma.
"I panicked when I heard the word cancer," Garabet said. At the
same time, he was relieved to know what was causing his
symptoms.
Garabet met Herrera and instantly felt he was in good hands. "He
explained everything so well," he added. Garabet enrolled in the
trial. After his first infusion, he felt exhausted but that was the
worst he felt during treatment. After only four infusions, he was
in remission. He was advised to continue the treatment in case any
cancer lingered, and he did. "Now when people tell me they have
cancer, I tell them not to panic. There are a lot of cures now," he
added.
The S1826 trial, supported by the NCI and led by SWOG, is the
largest classic Hodgkin lymphoma study ever conducted in the NCI's
National Clinical Trials Network and is also representative of a
diverse patient population. About a quarter of the enrolled
patients were Black or Hispanic. A partnership with the Children's
Oncology Group (COG) helped ensure the trial included young
adolescents, and a quarter of enrolled patients were younger than
18 years old. Nearly two-thirds of all patients had Stage 4
cancer.
"This study speaks to the power of the National Clinical Trials
Network and is an excellent example of the transformative work that
the NCI funds," said Jonathan
Friedberg, M.S., M.M.Sc., senior author of the study, chair
of the SWOG Cancer Research Network's lymphoma committee and
director of the Wilmot Cancer Institute at the University of Rochester. "Hodgkin lymphoma is not a
common disease and the NCTN enabled a large network of more than
200 pediatric and adult community providers and academic medical
centers to work together. Because of that, we were able to get data
very quickly and directly impact patient care. This was a critical
investment in cancer research and treatment."
Patients with Stage 3 or 4 classic Hodgkin lymphoma who had not
been previously treated and were age 12 or older were eligible for
the trial. Of a total of 976 eligible patients, 489 were enrolled
in the N-AVD arm (nivolumab plus Adriamycin, vinblastine and
dacarbazine), while 487 were part of the BV-AVD group. Each group
received six infusion cycles of each combination therapy.
As expected with combination chemotherapy, the most common side
effects included gastrointestinal and hematologic toxicities, and
fatigue. However, less than 1% of patients needed radiation after
trial treatment, which is a dramatic reduction in the proportion of
patients being initially treated for Hodgkin lymphoma who need
radiation, especially among pediatric patients.
"The ability to maintain high rates of relapse-free survival
with minimal use of radiation therapy in children with newly
diagnosed advanced stage Hodgkin lymphoma will be a paradigm
shift," said Sharon Castellino,
M.D., M.Sc., chair of the COG Hodgkin lymphoma committee and
director of the Leukemia and Lymphoma Program at the Aflac Cancer
and Blood Disorders Center, Children's Healthcare of Atlanta, Winship Cancer Institute at
Emory University.
Brentuximab vedotin was the first antibody-drug conjugate
developed for classic Hodgkin lymphoma. Several studies have
demonstrated that incorporating the therapy into frontline
treatment improves progression-free survival and overall survival.
Despite improved outcomes, there are still serious side effects;
relapses can occur.
"There is definitely a need to improve frontline therapies for
Hodgkin lymphoma, particularly because a disproportionate number of
patients with this disease are teens and young adults," Herrera
added.
PD-1 checkpoint inhibitors are a powerful and growing form of
immunotherapy used to treat melanoma, kidney cancer, head and neck
cancers, relapsed or difficult to treat Hodgkin lymphoma and other
cancers. The PD-L1 protein is expressed on Hodgkin lymphoma tumor
cells and aids the cancer by signaling to immune cells, such as T
cells, to stop working against tumors.
Checkpoint inhibitors block the PD-L1 protein to help the immune
system and, specifically, T cells, do what they're designed to do,
eradicate cancer. In this study, adding nivolumab to
chemotherapy worked so well that some patients experienced
remission after only a few treatments.
Next steps for the trial include following patients to measure
the durability of progression-free survival, overall survival and
other patient outcomes.
Funding was provided by: National Cancer Institute of the
National Institutes of Health U10CA180888, U10CA180819,
U10CA180820, U10CA180821, U10CA180863, U10CA180886 and
Bristol-Myers Squibb through a Cooperative Research and Development
Agreement between the NCI and BMS. Brentuximab vedotin was provided
by Seagen.
In addition to Herrera and Friedberg, co-authors on the
presentation include Michael L.
LeBlanc, Ph.D., SWOG Statistical Center and Fred Hutchinson
Cancer Center; Sharon M. Castellino,
M.D., M.Sc., Emory University, Aflac
Cancer and Blood Disorders Center, Children's Healthcare of
Atlanta; Hongli Li, M.S., SWOG Statistical Center and
Fred Hutchinson Cancer Center; Sarah C.
Rutherford, M.D., Weill Cornell Medicine-New York
Presbyterian Hospital; Andrew M Evens, D.O., M.Sc., Rutgers Cancer
Institute of New Jersey;
Kelly Davison, M.D., McGill University; Angela
Punnett, M.D., Hospital for Sick Children, Toronto; David C.
Hodgson, M.D., M.P.H., Department of Radiation Oncology,
Princess Margaret Cancer Centre, University Health Network; Susan K
Parsons, M.D., M.R.P., Tufts Medical Center, Tufts University School of Medicine; Sairah Ahmed, M.D., University of Texas MD Anderson Cancer Center;
Carla Casulo, M.D., Division of
Hematology/Oncology, University of
Rochester; Nancy L. Bartlett,
M.D., Washington University School of
Medicine in St. Louis;
Joo Y. Song, M.D., Department of
Pathology, City of Hope; Richard F.
Little, M.D., Cancer Therapy Evaluation Program, National
Cancer Institute; Brad S. Kahl,
M.D., Washington University School of
Medicine in St. Louis;
John P. Leonard, M.D., Weill Cornell
Medicine-New York Presbyterian Hospital; Sonali M. Smith, M.D., Department of Oncology,
University of Chicago; and Kara M. Kelly, M.D., Department of Pediatric
Oncology, Roswell Park Comprehensive Cancer Center.
About SWOG
SWOG Cancer Research Network is part of the National
Cancer Institute's National Clinical Trials Network and the NCI
Community Oncology Research Program and is part of the oldest and
largest publicly funded cancer research network in the nation. SWOG
has more than 18,000 members in 45 states and nine foreign
countries who design and conduct clinical trials to improve the
lives of people with cancer. SWOG trials have led to the approval
of 14 cancer drugs, changed more than 100 standards of cancer care,
and saved more than 3 million years of human life. Learn more at
swog.org, and follow us on Twitter at @SWOG.
About City of Hope
City of Hope's mission is to deliver the cures of tomorrow to
the people who need them today. Founded in 1913, City of
Hope has grown into one of the largest cancer research and
treatment organizations in the U.S. and one of the leading research
centers for diabetes and other life-threatening illnesses. City of
Hope research has been the basis for numerous breakthrough
cancer medicines, as well as human synthetic insulin and monoclonal
antibodies. With an independent, National Cancer
Institute-designated comprehensive cancer center at its
core, City of Hope brings a uniquely integrated model to
patients spanning cancer care, research and development, academics
and training, and innovation initiatives. City of Hope's growing
national system includes its Los
Angeles campus, a network of clinical care locations across
Southern California, a new cancer
center in Orange County,
California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope's affiliated group of
organizations includes Translational Genomics Research
Institute and AccessHopeTM. For more
information about City of Hope, follow us
on Facebook, Twitter, YouTube, Instagram and LinkedIn.
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SOURCE City Of Hope