CLINICAL NEWS
Latest & Greatest
NCI Launches MATCH
Trial to Link Gene
Mutations with
Appropriate Cancer
Treatments
Going Viral: A New Test Detects Lifetime Virus
Exposure with a Single Drop of Blood
VirScan, a recently developed, highthroughput blood test, can detect nearly
every virus a person has been exposed
to in his or her lifetime, according to a
study reported in Science. The test may be
useful for tracking disease patterns across
age groups and geographic populations,
as well as studying complex, chronic
diseases, such as cancer, diabetes, and
autoimmune diseases.
“In addition to directly causing acute
or chronic illness, viral infections can alter
host immunity in more subtle ways, leaving an indelible footprint on the immune
system,” the authors wrote. “VirScan may
prove to be an important tool for uncovering the effect of host-virome interactions
on human health and disease and could
easily be expanded to include new viruses
as they are discovered, as well as other
human pathogens.”
Current serologic methods of viral detection are limited to testing one pathogen
at a time and are used primarily to address
specific clinical hypotheses. VirScan, however, allows for a comprehensive analysis
of antiviral antibodies in human sera
using less than 1 μl of blood.
The researchers tested VirScan on 569
ASHClinicalNews.org
individuals living in the United States,
South Africa, Thailand, and Peru, assaying
antibody-peptide interactions for reactivity to 206 human viral species and more
than 1,000 strains. Most study participants
were exposed to approximately 10 species
of virus, with two participants being exposed to as many as 84 viruses. In general,
those living outside of the United States
were exposed to more viruses.
In terms of performance, the new
blood test’s ability to detect known infections and distinguish between exposures
to related viruses was comparable to that
of classical serum antibody tests for single
viruses. The researchers noted, however,
that the test can only detect identified viruses and may overlook very small viruses
or past infections that occurred when the
immune response was not as robust.
The test, which can be performed
for $25, currently takes two days to two
months to complete, though the developers are looking to streamline the test’s
processes and produce results in as few as
two to three days.
Source: Xu GJ, Kula T, Xu Q, et al. Comprehensive serological profiling of
human populations using a synthetic human virome. Science. 2015 June
5. [Epub ahead of print]
The National Cancer Institute (NCI)
announced the launch of a phase II,
nationwide trial that will determine
links between cancer treatment options
and gene mutations. The trial, called
NCI-MATCH (Molecular Analysis for
Therapy Choice), began patient enrollment in July, screening individuals from
2,400 U.S. sites.
“NCI-MATCH is a unique, groundbreaking trial,” said Doug Lowy, MD, the
acting director at NCI, in a press release.
Because many gene mutations in tumors
are infrequent or unique, screening for
individual mutations is not cost-effective
or efficient in clinical trials. Instead,
NCI-MATCH will use advanced gene sequencing techniques to screen for many
molecular abnormalities at once.
“It is the first study in oncology that
incorporates all of the tenets of precision
medicine,” Dr. Lowy said, “and holds the
potential to transform cancer care.”
The study was co-developed by the
NCI, part of the National Institutes of
Health, and the ECOG-ACRIN Cancer
Research Group, part of the NCI-sponsored National Clinical Trials Network
(NCTN).
NCI-MATCH will begin with a DNA
analysis of tumor biopsies from approximately 3,000 patients. The samples
will undergo DNA sequencing to detect
genetic abnormalities that may be driving cancer growth and could be targeted
by one of the drugs in the study. Patients
will then be treated with the targeted regimen for as long as their tumor shrinks
or remains stable. Patients are expected
to have one or at most two treatable mutations in the tumors. Investigators hope
to enroll about 1,000 patients in the various treatment arms. The study drugs that
will be used in the trial are either already
approved by the U.S. Food and Drug
Administration (FDA) or are currently
under development in clinical trials.
The study will include additional
small arms for each treatment being
investigated, starting with approximately
10 arms and potentially expanding to
20 or more. Patients will be assigned to
treatment options based on their individual gene mutations – not the location
of the cancer. Each arm will enroll up to
35 patients.
To be included in the trial, participants
must be 18 years of age or older with solid
tumors or lymphomas that have advanced
following at least one line or standard systemic therapy, or those whose tumors have
no standard treatment available.
The study’s primary endpoint is the
overall response rate, with a secondary
endpoint of six-month progression-free
survival.
To be deemed successful, the researchers
are looking for a tumor reduction of at least
16 percent; response rates less than 5 percent
will be deemed unsuccessful.
Source: National Cancer Institute press release
New Approach Uses
Patients’ Own Bone
Marrow T-Cells to Treat
Multiple Myeloma
According to results of a new proof-ofprinciple study recently reported in Science
Translational Medicine, a patient’s bone
marrow T cells may provide a new form of
treatment for multiple myeloma (MM).
“Successful adoptive T-cell therapy
(ACT) requires the ability to activate
tumor \