GENOMIC TESTING

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. elio^TM tissue complete assay for use in a Merck trial evaluating pembrolizumab combinations in non–small cell lung cancer, according to a press release from PGDx, developer of the assay.

A plethora of new technology has been developed to assist in identifying targetable mutations, including next- generation sequencing. NGS assays that identify tumor genes can range in use from targeted to comprehensive panels, all of which have accelerated the advancement of personalized medicine.

Precision medicine has afforded oncologists the opportunity to develop individualized approaches to treat non–small cell lung cancer, one of the most devastating malignant disorders, which until the past decade was thought to be invariably fatal within months.

In an interview with Targeted Oncology, Willemina R. Geurts-Giele, PhD, discussed the accuracy of detecting MET exon 14 skipping mutations in patients with NSCLC with DNA-based NGS panels. These findings were presented at The Association for Molecular Pathology Annual Meeting and Expo.

The emergence of resistance mutations in patients with cancer who receive targeted therapies is an expected development that will require new diagnostic methods of identifying the mechanisms through which these alterations occur, according to Fei Dong, MD, during the 2019 Association for Molecular Pathology Annual Meeting.<br /> &nbsp;

In a presentation describing the utility of circulating tumor DNA liquid biopsy assays at the 14th Annual New York Lung Cancers Symposium, Bob T. Li, MD, MPH, said that plasma genotyping demsonstrates practice-changing potential in non&ndash;small cell lung cancer.

Testing for driver mutations is essential before initiating therapy in patients with non&ndash;small cell lung cancer, because there is a risk that the type of upfront treatment chosen could add to the toxicity of, and spur resistance to, targeted therapy options, Suresh S. Ramalingam, MD, said at the 14th Annual New York Lung Cancers Symposium.

Kevin Halling, MD, PhD, discussed the clinical utility of RNA-sequencing methods in patients with cancer at the 2019 Association for Molecular Pathology Annual Meeting and Expo. Halling says RNA sequencing is a very powerful diagnostic technique.

At the 2019 Association for Molecular Pathology Annual Meeting and Expo, Adam Fisch, MD, PhD, presented a unique patient case where a patient with acute myeloid leukemia harboring a <em>FLT3</em>-TKD mutation lost the mutation following relapse on gilteritinib.<br /> &nbsp;

Leonard G. Gomella, MD, discusses the factors that determine which patients with prostate cancer should undergo genetic testing.

Yuma Regional Medical Center Cancer Center has implemented a genetic cancer screening and testing for their patients through collaboration with Myriad Genetics, a molecular diagnostic testing company, according to a presentation by Erica Martinez, RN, OCN, at the Association of Community Cancer Centers&rsquo; 2019 National Oncology Conference. After partnering with Myriad Genetics, the cancer center saw a 4-fold increase in genetic testing of patients with cancer in the first 4 months, which led to a change in clinical management in 20% of those cases.

In an interview with&nbsp;Targeted Oncology, Raoul S. Concepcion, MD, discussed the existing challenges with implementing genetic testing and genetic counseling in community practices and how they can potentially be addressed.

Among patients with acute myeloid leukemia and myelodysplastic syndrome who completed myeloablative allogeneic hematopoietic stem cell transplantation, the predictive utility of testing circulating tumor DNA was comparable with that of mutation persistence evaluation in matched bone marrow samples, according to a study published recently in Blood.

Matthew P. Goetz, MD, discusses how genomic assays can help identify patients with ER&ndash;positive breast cancer who will benefit from the addition of chemotherapy to endocrine therapy.

In a presentation at the 2019 ESMO Congress on a case series of 7 pretreated patients with <em>NRG1</em>-positive tumors, Stephen Liu, MD, and colleagues discussed the efficacy of afatinib and explained that afatinib may be a potential treatment option for <em>NRG1</em>-positive tumors across multiple cancer types.

Findings from an interim analysis of the National Lung Matrix Trial, a large, multiarm trial involving patients with non&ndash;small cell lung cancer, demonstrated both promising activity and shortcomings in predefined goals in a presentation at the 2019 World Conference on Lung Cancer.

At the recent <em>20th Annual </em>International Lung Cancer Congress&reg; in Huntington Beach, California, a number of very prominent contributors to the lung cancer translational and clinical field provided updates regarding novel strategies to address unmet needs.

Multiple presentations at the 2019 ESMO Congress add to the evidence that blood-based biomarkers have predictive utility in advanced non-small cell lung cancer. Blood-based next-generation sequencing has also shown clinical utility in aiding treatment decisions for physicians treating this disease.

In an interview with&nbsp;<em>Targeted Oncology</em>, Gregory Gores, MD explained the role of molecular therapy and the use of genetic testing to guide treatment of iCCA.

Gulam A. Manji, MD, PhD, discusses the need to identify mutations that may be actionable in patients with colorectal cancer. The identification of such mutations can further impact patient survival and improve efficacy, says Manji, in both CRC and other gastrointestinal cancers.

In an interview with <em>Targeted Oncology</em>, Dean A. Fennell, MD, PhD, explained the need for the MIST trial and personalized treatment for patients with mesothelioma.

Advances in molecular profiling have driven development and use of personalized medicine approaches in oncology, enabling detection of biomarkers for predicting prognosis and treatment response and determining inheritable cancer risk.

Timothy F. Burns, MD, PhD, discusses the necessary role of next-generation sequencing testing in patients with lung adenocarcinoma. In order to incorporate this into clinical practice, there is still a lot more work to be done, Burns says. Around 20% to 25% of patients with adenocarcinoma have targetable alterations.

Treatment with selpercatinib induced responses in 68% of patients with&nbsp;<em>RET&nbsp;</em>fusion&ndash;positive non&ndash;small cell lung cancer, according to findings from the phase I/II LIBRETTO-001 trial.

In a recent analysis published in <em>JAMA</em>, data were evaluated from a collection of clinical trials and analyzed for important takeaways in the testing and treatment of patients with non&ndash;small cell lung cancer. The authors stress the importance of molecular testing in patients with NSCLC as more targeted therapies become available.&nbsp;<br /> &nbsp;