CAP Publishes Guideline for PD-L1 Testing of Patients with Lung Cancer
April 16 2024 - 3:00PM
Business Wire
The College of American Pathologists (CAP) in collaboration with
the International Association for the Study of Lung Cancer (IASLC),
Pulmonary Pathology Society (PPS), Association for Molecular
Pathology (AMP) and the LUNGevity Foundation have developed
evidence-based recommendations for the testing of immunotherapy
biomarkers, including Programmed Cell Death Ligand-1 (PD-L1) and
tumor mutation burden (TMB) in patients with non-small cell lung
carcinoma (NSCLC).
“Many lung cancer patients may benefit from therapies that can
harness the immune system, including anti-PD-1 or PD-L1 therapies.
However, the benefit of these therapies is not universal, and
clinically validated biomarkers that can help predict response
include PD-L1 expression and proposed tumor mutational burden
(TMB),” explains Larissa Furtado, MD, FCAP. “This guideline is
intended to provide an overview of the clinical rationale for the
use of PD-L1 and tumor mutational burden (TMB) testing for patients
with non-small lung cancer. It highlights the technical challenges
of PD-L1 testing and interpretation, including some of the
complexities introduced by the development of divergent companion
diagnostic PD-L1 tests for different immune checkpoint blockade
therapies. It outlines the rationale for use of TMB and the current
limitations of this test for lung cancer patients.”
This guideline, now available in an early online release in the
Archives of Pathology & Laboratory Medicine, was driven by
production of PD-L1 assays and scoring criteria that have evolved
with individual therapies. At the same time, for reasons of cost
and access, PD-L1 IHC antibodies and assays developed outside of
the scope of randomized controlled trials have garnered widespread
use.
“Clinical trials have demonstrated that drugs that block
Programmed Cell Death 1 (PD-1), and PD-L1 lead to significant
improvements in both response and survival relative to conventional
cytotoxic chemotherapy for patients with advanced stage NSCLC,”
explained guideline update co-chair Lynette Sholl, MD, FCAP.
The expert panel recognized that the regulatory-approved
diagnostics are clinically validated, and as such their use is
recommended. However, most laboratories may be relying on
laboratory developed tests (LDTs) because of limited access to a
full suite of approved clones and platforms, as well as the
increased cost of running companion diagnostic-labeled assays. “To
ensure patient access to PD-L1 testing, particularly at the local
level, we endorse the use of LDTs and validated PD-L1 IHC (LDTs)
following technical validation against one or more of the approved
companion diagnostic PD-L1 assays,” said Dr. Furtado.
With six recommendations, the guideline provides data and
details regarding the efficacy and utility of PD-L1 testing of
patients with lung cancer. This new guideline was developed by
IASLC, PPS, the LUNGevity Foundation and the CAP Center, which
develops evidence-based guidelines and consensus statements related
to the practice of pathology and laboratory medicine. Through this
work, the CAP and its members continually improve the quality of
diagnostic medicine and patient outcomes. Current tools, resources,
and information for the PD-L1 Testing of Patients with Lung Cancer
Guideline can be found on the guideline webpage on cap.org.
About the College of American Pathologists
As the world’s largest organization of board-certified
pathologists and leading provider of laboratory accreditation and
proficiency testing programs, the College of American Pathologists
(CAP) serves patients, pathologists, and the public by fostering
and advocating excellence in the practice of pathology and
laboratory medicine worldwide. For more information, visit the CAP
Newsroom, CAP.org and yourpathologist.org to watch pathologists at
work and see the stories of the patients who trust them with their
care.
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Abby Watson 847-832-7513 media@cap.org