Immunotherapy drug improves outcomes for some children with relapsed leukemia

Cancer

New York, 11th
December 2019 : New findings from a clinical trial show that treatment
with the immunotherapy drug blinatumomab
is superior to standard
chemotherapy for children
and young adults with high- or
intermediate-risk B-cell acute lymphoblastic leukemia (B-ALL) that has
relapsed.

Those
treated with blinatumomab had longer survival, experienced fewer severe side
effects, had a higher rate of undetectable residual disease, and were more
likely to proceed to a stem cell transplant.

“Our study
demonstrates that immunotherapy with blinatumomab is more effective and less
toxic than chemotherapy as a bridge to curative bone marrow transplant for
children and young adults with very aggressive relapse of B-ALL,” said Patrick
Brown, M.D., who chaired the trial and is director of the Pediatric Leukemia
Program at the Johns Hopkins Kimmel Cancer Center, Baltimore.

“We are
thrilled that these patients, whose survival has not substantially improved for
decades, now have a new and better standard of care.”

The findings
were presented as a late-breaking abstract at the American Society of
Hematology (ASH) annual meeting on Dec. 10, 2019.

The trial
was led by the Children’s Oncology Group (COG), part of the
National Cancer Institute (NCI)–sponsored National Clinical Trials Network. NCI
is part of the National Institutes of Health of U.S. Department of Health and
Human Services.

Amgen
reviewed the trial protocol and amendments and provided the study drug under a
Cooperative Research and Development Agreement with NCI.

“These
findings will likely have immediate impact on the treatment of this group of
children and young adults with relapsed B-ALL,” said Malcolm Smith, M.D.,
Ph.D., associate branch chief for pediatric oncology in NCI’s Cancer Therapy
Evaluation Program, which sponsored the trial.

“These
results also reinforce the important role that federally funded clinical trials
play in developing more effective treatments for children with cancer.”

When
children have B-ALL that relapses after their initial treatment, they are
typically given chemotherapy.

The first
four to six weeks of chemotherapy, the reinduction phase, is commonly followed
by additional intensive chemotherapy, or consolidation treatment, to further
reduce disease levels. Following this, hematopoietic stem cell transplant is
considered the best treatment for approximately half of patients, based on
factors such as whether relapse occurred during initial treatment or shortly
after it was completed.

Chemotherapy
can produce severe side effects

However,
chemotherapy can produce severe side effects in some patients and is sometimes
ineffective in reducing leukemia levels to the low levels needed prior to
transplant. As a result, patients may not be able to proceed to transplant or
transplant may be delayed, which increases the risk that the leukemia will
return.

The COG
study investigated blinatumomab as an alternative type of consolidation
treatment to follow the reinduction phase.

Blinatumomab
is a type of immunotherapy that works by binding to two different molecules:
CD19, a protein, or antigen, expressed on the surface of B-ALL cells, and CD3,
an antigen expressed on T cells. By bringing T cells close to leukemia cells,
the immunotherapy helps the T cells recognize and kill the cancer cells.

Blinatumomab
has been approved by the U.S. Food and Drug Administration (FDA) for adults and
children with B-ALL that has returned or has not responded to treatment. FDA
has also granted accelerated approval to the drug—meaning confirmatory trials
must show it has clinical benefit—for some adults and children undergoing
treatment for B-ALL who achieve complete remission but still have small amounts
of leukemia detectable using very sensitive methods.

Investigators
in this study wanted to see if blinatumomab could increase rates of survival
free from leukemia and be less toxic than intensive chemotherapy in children
and young adults undergoing consolidation treatment.

The trial
report was based on 208 children and young adults aged 1–30 with relapsed B-ALL
who had received reinduction chemotherapy and were considered to have high- or
intermediate-risk disease. They were randomly assigned to receive either two
rounds of intensive chemotherapy or two 4-week rounds of treatment with
blinatumomab before proceeding to a transplant. (A separate part of the study
addressed children with low-risk disease.)

After a
median follow-up time of 1.4 years, those in the blinatumomab group had higher
rates of 2-year disease-free survival, the primary outcome of the study, than
those who received intensive chemotherapy (59.3 ± 5.4% vs. 41 ± 6.2%). Those
treated with blinatumomab also had higher rates of overall survival (79.4 ±
4.5% vs. 59.2 ± 6%), fewer severe side effects, a higher rate of undetectable
residual disease (79% vs. 21%), and a higher rate of proceeding to stem cell
transplant (73% vs. 45%).

At a planned
interim analysis, an independent data safety monitoring committee concluded
that the outcome for children treated with blinatumomab was superior to that of
children treated with chemotherapy only and recommended that enrollment to the
high- and intermediate-risk part of the trial be stopped.

Future clinical trials will study whether blinatumomab’s effects in relapsed B-ALL can be enhanced by combining it with other immunotherapy and will test whether adding the drug to standard chemotherapy for children and young adults with newly diagnosed B-ALL is beneficial.

Immunotherapy drug improves outcomes for some children with relapsed leukemia was originally published by the National Cancer Institute

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