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lite.cnn.com - on gopher - inofficial
ARTICLE VIEW:
Immunotherapy improves survival in people with advanced Hodgkin
lymphoma, study shows
By Jacqueline Howard, CNN
Updated:
5:00 PM EDT, Wed October 16, 2024
Source: CNN
An immunotherapy approach to treating advanced Hodgkin lymphoma may
drastically increase patients’ chances of survival, including those
as young as 12, according to a new clinical trial.
The regimen, which involves the immunotherapy drug nivolumab along with
three different chemotherapies, was found to result in a two-year
progression-free survival rate of 92% in a phase three trial whose
results were published Wednesday in the .
“At two years, 92% of the patients did not relapse, did not have
progression of Hodgkin lymphoma and did not die,” Dr. Jonathan
Friedberg, lead study author and director of the Wilmot Cancer
Institute at the University of Rochester, said in a news briefing.
“The standard endpoint in studies of Hodgkin lymphoma is
progression-free survival, because we think that best predicts the
future,” he said. “If you can keep people disease-free and alive
for two years, generally speaking, it’s very unlikely that beyond two
years you’re going to have a lot of events, and therefore we’re
quite optimistic these results are going to be durable. But of course,
it’s going to be important to follow these patients for a longer
period of time.”
Hodgkin lymphoma is a type of cancer that , , which is part of the
body’s immune system.
The American Cancer Society estimates that will be diagnosed in the
United States this year, and about 900 people will die from the
disease. Hodgkin lymphoma can develop at any age, but it’s most
common in early adulthood. The average age at diagnosis is is 39, and
it’s the most common cancer diagnosed in adolescents ages 15 to 19.
‘An immunotherapy revolution’
The new study included nearly 1,000 people who were at least 12 years
old and newly diagnosed with stage III or IV Hodgkin lymphoma that had
previously been untreated.
Between July 2019 and October 2022, the patients were randomly assigned
to receive one of two treatment regimens; 496 patients were assigned to
receive the antibody drug brentuximab vedotin along with the
chemotherapy drugs doxorubicin, vinblastine and dacarbazine, while 498
others received nivolumab along with that same trio of chemotherapies.
The patients received the treatments intravenously on the first day and
then about two weeks later within a 28-day cycle. This was repeated for
six cycles.
The patients were based at 256 sites across the United States and
Canada. One of the sponsors of the trial was Bristol-Myers Squibb,
which makes nivolumab and supplied the drug for the study.
A combination of chemotherapies has been the standard treatment for
advanced-stage Hodgkin lymphoma for decades, but the researchers
watched each patient closely to analyze how they responded to the drug
combinations.
The researchers found that the nivolumab treatment regimen
significantly improved survival compared with the brentuximab vedotin
regimen. About two years after starting treatment, 92% of patients in
the nivolumab group survived without relapse and without seeing the
cancer progress, compared with 83% of those in the brentuximab vedotin
group.
These patients who survived without cancer progression also did not
need radiation therapy, which can result in significant side effects,
such as the risk of additional cancers or fertility problems. In the
study, only seven patients overall received radiation therapy.
The researchers noted that there were more adverse side effects in the
brentuximab vedotin group compared with the nivolumab group, but a
condition called neutropenia – in which the body has low levels of a
type of white blood cell – was more prevalent in the nivolumab group.
Neutropenia occurred in 56% of patients taking nivolumab versus 34%
of those who got the brentuximab vedotin treatment.
“The one side effect that we saw that seemed higher in the nivolumab
arm was neutropenia, and that’s low white blood counts that can
result in an increased risk of infection,” Friedberg said.
The researchers knew that neutropenia may be a risk with brentixuimab,
so more than than 90% of the patients given that treatment also
received a “growth factor” medication to help evade neutropenia as
a side effect. In the nivolumab group, only 50% of patients got that
“growth factor” support.
“So it’s really not surprising that we’d see a slightly higher
risk of neutropenia,” Friedberg said.
The researchers found that, overall, the nivolumab approach had a
better side-effect profile, with fewer patients stopping treatment
early, fewer deaths during treatment and a low incidence of
immune-related toxic effects.
There were seven deaths from any cause in the nivolumab group, among
which three were during treatment, compared with 14 in the brentuximab
vedotin group, among which eight were during treatment, according to
the study.
“In the context of a disease in which a high proportion of patients
are cured with standard therapy and the bar to change practice is set
high, the improvement in efficacy and in the risk of adverse events was
clinically meaningful,” the researchers wrote.
As the study followed patients for only two years, the researchers plan
to continue to monitor them and provide updates, Friedberg said. The
researchers hope the US Food and Drug Administration soon will
determine whether nivolumab should be added as a standard treatment for
stage III or IV Hodgkin lymphoma, and they plan to start the formal
process to ask the agency to expand the approval of nivolumab in the
near future.
Nivolumab, , has been approved by the FDA to be included in treatment
regimens for many other types of cancer, including , and . It’s
unclear how much a nivolumab treatment for Hodgkin lymphoma may cost,
but an infusion of 240 milligrams – the maximum dosage given to the
patients in the new trial – every two weeks has a , according to
Bristol Myers Squibb’s .
“We’re in the midst of an immunotherapy revolution in the treatment
of cancer,” Friedberg said.
“For decades, people tried and failed, and within the last six to 10
years, we’ve seen dramatic changes in not just Hodgkin lymphoma but
many more common cancers like lung cancer and melanoma,” he said.
“Unfortunately, for many of the more common cancers, although
immunotherapy seems to work, it’s not a definitive cure, and a lot of
the research now is looking to join immunotherapy with other standard
approaches to see if that one-two punch, so to speak, may ultimately be
curative.”
‘A change in the standard of care’
Many insurance companies have been approving the use of nivolumab with
chemotherapies as an off-label treatment for Hodgkin lymphoma, said Dr.
Ann LaCasce, director of the Dana-Farber/Mass General Brigham
Fellowship in Hematology/Oncology.
“The publication of this randomized clinical trial provides high
level evidence supporting the regimen’s use,” LaCasce, a lymphoma
specialist who was not involved in the new study, wrote in an email.
“This is a very important study that leads to a change in the
standard of care for pediatric and adult patients in the U.S. with
advanced stage classic Hodgkin lymphoma,” she said. “The trial was
a successful collaboration between adult and pediatric investigators
and included a diverse group of patients with respect to age, race, and
ethnicity. This sets the stage for future collaborative studies.”
The traditional approach to Hodgkin lymphoma treatment has emphasized
the use of chemotherapy drugs and radiation therapy to kill cancer
cells, Dr. James Armitage of the University of Nebraska Medical Center
and Dr. Dan Longo of Brigham and Women’s Hospital wrote in an
editorial published alongside the new study.
“However, insights in the field of cancer biology identified other
potential approaches to cancer treatment in general and Hodgkin’s
lymphoma in particular. Two notable examples are targets of
immunotherapy approaches,” Armitage and Longo said.
“The nivolumab regimen is easy to deliver, is associated with modest
toxic effects, and is highly effective,” they wrote, adding that the
latest trial suggests that the nivolumab approach “may become the
treatment of choice” for all stages of Hodgkin’s lymphoma.
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