Outcomes point to value of biomarker testing
in addressing testing gaps in clinical practice
BURLINGTON, N.C., March 16,
2024 /PRNewswire/ -- Labcorp (NYSE: LH), a
global leader of innovative and comprehensive laboratory services,
today presented the results from two studies at the 2024 SGO
Annual Meeting on Women's Cancer. The studies demonstrate the value
of biomarker testing in closing testing gaps and guiding
targeted therapies for patients with epithelial ovarian cancer
(EOC).
With the rapid rate at which cancer biomarkers are being
identified and new targeted therapies become available,
comprehensive testing approaches are becoming even more critical as
corresponding treatment guidelines evolve. Labcorp researchers
conducted two studies to generate further evidence of the value of
comprehensive genomic profiling to drive guideline-compliant
testing that enables increased patient access to targeted therapies
for improved outcomes.
Combination of BRCA testing with HRD Testing Needed to
Inform Benefit of PARP Inhibitor Therapy
In one such study,
conducted in partnership with Illumina, a leader in next-generation
sequencing technologies, 1,093 patients diagnosed with EOC were
evaluated to assess real-world clinical practice patterns for
ordering BRCA and Homologous Recombination Deficiency (HRD)
testing. When combined, the results of BRCA and HRD testing
can determine which patients are most likely to benefit from
treatment with poly-ADP ribose polymerase (PARP) inhibitors. For
patients who test negative for BRCA1 and BRCA2,
testing for HRD can help determine the degree of benefit from a
PARP inhibitor.1
PARP inhibitors have transformed the standard of care,
especially for women with germline or deleterious somatic mutations
in BRCA1 or BRCA2.2 However, at least 40%
of patients do not respond to PARP inhibitors, and if treated
with PARP inhibitors, may experience longer treatment durations and
potentially serious side effects,3 as well as increased
overall costs. Treatment guidelines for PARP inhibitors emphasize
the importance of diagnostic testing and individualized patient
assessments.1
Within the study population, 84% of patients underwent
evaluation for BRCA mutations or HRD testing; however, less
than 50% of patients underwent HRD testing. Researchers then
evaluated PARP inhibitor utilization and evaluated the time to
treatment discontinuation (TTD) among patients with
germline/somatic BRCA mutations, tumors with HRD, and those
that were homologous recombination proficient (HRP). Patients with
BRCA mutations4 or HRD[5] tend to do well on PARP
inhibitors, so testing for each can help identify patients who may
be most appropriate for PARP inhibitor maintenance.
Consistent with prior prospective clinical trials, researchers
reported that the median TTD of first-line PARP inhibitor
maintenance therapy was the longest for patients with germline or
somatic BRCA mutations or HRD tumors. Among the study
groups, 77% of the patients with a germline BRCA mutation,
65.1% of patients with a somatic BRCA mutation, and 42.7% of
those with HRD and BRCA wild-type continued PARP inhibitor
therapy at 18 months, compared to 29% of patients in the
HRP/BRCA wild-type group.
"This research emphasizes the power of comprehensive biomarker
testing in advancing the treatment of ovarian cancer. By closing
critical diagnostic gaps through precision testing, we are not just
improving patient care but also propelling science and healthcare
forward," said Shakti Ramkissoon, M.D., Ph.D., vice president, head
of oncology at Labcorp. "These findings affirm that access to
advanced technology, in collaboration with partners with a shared
commitment to the most current care models, is the cornerstone of
developing innovative diagnostic tools. These new assays can offer
more patients with access to effective, biomarker-guided therapies,
ultimately leading to better prognoses and opening doors to new
possibilities in gynecologic oncology."
The studies are among the growing body of evidence highlighting
the value of biomarker testing for EOC, specifically in real-world
settings. High-grade serous epithelial ovarian cancer (HGSOC) is
the deadliest of all gynecological cancers, with 70% of patients
having a cancer recurrence within two to three years and almost 50%
dying from the disease after five years of diagnosis.
"This research highlights the need for additional healthcare
provider education on comprehensive genomic approaches and the
clinical utility of guideline-driven testing to improve patient
care in ovarian cancer," said Pratheesh
Sathyan, head of oncology for Americas region in medical
affairs at Illumina.
High Folate-receptor Alpha (FOLR1/FRα) Expression Seen in
Primary EOC Tumors
In another study, Labcorp researchers
evaluated real-world testing practice patterns for Folate-receptor
Alpha (FRα) on primary tumors versus metastatic tumors to guide
targeted therapy for patients with platinum-resistant EOC. FRα is
an actionable biomarker in ovarian cancer and is overexpressed in
up to 90% of EOC patients.6 Patients with
platinum-resistant EOC whose tumors highly express FRα may be
eligible for treatment with Mirvetuximab soravtansine (MIRV), the
only currently available targeted therapy that improves overall
survival for patients with platinum-resistant EOC.
Researchers performed a retrospective analysis of tumor samples
from 432 patients with EOC undergoing standard-of-care testing via
the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (developed by Roche). Of
the tumor samples analyzed, 291 were from metastatic tumors, and
133 were from primary tumors. Researchers reported that 36.2% of
patients had tumors that highly expressed FRα. In a critical study
finding, tumor samples from primary sites were associated with
higher rates of FRα positivity than those from metastatic
sites.
"This study demonstrates not only the important role that
FOLR1 testing can play in developing treatment strategies, but
how it can help guide clinicians on the appropriate tumor sites to
test to acquire the best information for that treatment guidance,"
said Ramkissoon.
About Labcorp
Labcorp (NYSE: LH) is a global leader of
innovative and comprehensive laboratory services that helps
doctors, hospitals, pharmaceutical companies, researchers and
patients make clear and confident decisions. We provide insights
and advance science to improve health and improve lives through our
unparalleled diagnostics and drug development laboratory
capabilities. The company's more than 67,000 employees serve
clients in over 100 countries, worked on over 84% of the new drugs
approved by the FDA in 2023 and performed more than 600 million
tests for patients around the world. Learn more about us at
www.labcorp.com.
1 Antitumor
efficacy of PARP inhibitors in homologous recombination deficient
carcinomas
|
2 Poly(ADP-Ribose) Polymerase
Inhibitors in the Management of Ovarian Cancer: ASCO Guideline
Rapid Recommendation Update
|
3 PARP
Inhibitors: Clinical Limitations and Recent Attempts to Overcome
Them
|
4 Maintenance Olaparib in Patients
with Newly Diagnosed Advanced Ovarian Cancer
|
5 First-line PARP inhibition in
ovarian cancer — standard of care for all?
|
6 Final
SORAYA Analysis Supports Mirvetuximab Soravtansine in Ovarian
Cancer
|
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SOURCE Laboratory Corporation of America Holdings