Apar Kishor Ganti, MD, is a professor in the University of Nebraska Medical Center Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center

Allison Cushman-Vokoun, MD, PhD, FCAP, is the Henry F. Krous Professor of Pathology, a professor in the UNMC Department of Pathology, Microbiology and Immunology, director of the Division of Diagnostic Molecular Pathology and Human Genetics, medical director of the Molecular Diagnostics and Personalized Medicine Laboratory at Nebraska Medicine, director of the Molecular Genetic Pathology Fellowship Program, and associate director of the UMNC MD-PhD Scholars Program

, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by Thermo Fisher Scientific, we had the pleasure of speaking with Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP, about the 

FDA approval of the Oncomine DX Express Test

 for use as a companion diagnostic for sunvozertinib (Zegfrovy) in 

 exon 20 insertion mutation–positive non–small cell lung cancer and for use in tumor profiling. Dr Ganti is a professor in the University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center in Omaha. Dr Cushman is the Henry F. Krous Professor of Pathology, a professor in the UNMC Department of Pathology, Microbiology and Immunology, director of the Division of Diagnostic Molecular Pathology and Human Genetics, medical director of the Molecular Diagnostics and Personalized Medicine Laboratory at Nebraska Medicine, director of the Molecular Genetic Pathology Fellowship Program, and associate director of the UMNC MD-PhD Scholars Program. 

In our exclusive interview, Drs Ganti and Cushman discussed the significance of the launch of the Oncomine DX Express Test, the benefits and limitations of rapid next-generation sequencing, and features that set Oncomine DX apart from other available tests. 
___

That’s all we have for today! Thank you for listening to this episode of 

, supported by Thermo Fisher Scientific. Check back throughout the week for exclusive interviews with leading experts in the oncology field.

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Podcasts

Drs Ganti and Cushman discuss the launch of the Oncomine DX Express Test, as well as the benefits and limitations of rapid next-generation sequencing.

FDA Approval Insights: Oncomine DX Express Test Companion Diagnostic for Sunvozertinib in Non–Small Cell Lung Cancer: With Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP

Dr Ganti on the Importance of Molecular Testing in NSCLC

“Today, in lung cancer specifically, and most cancers, understanding the molecular makeup of the tumor is very important in deciding what treatment to give the patient.”

Apar Kishor Ganti, MD, a professor in the University of Nebraska Medical Center Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center, discussed the clinical implications of molecular testing results in patients with non–small cell lung cancer (NSCLC). He also highlighted the comprehensive profiling capabilities of the Oncomine DX Express Test.

FDA approved the Oncomine Dx Express Test

 on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic assay for use as a companion diagnostic for sunvozertinib (Zegfrovy) in patients with 

 exon 20 insertion mutation–positive NSCLC, as well as for use in tumor profiling.

In the contemporary management of lung cancer—as well as most other malignancies—characterizing the tumor’s molecular profile is essential for guiding therapeutic decisions, Ganti began. For instance, in patients with actionable mutations, such as 

, targeted therapies constitute the first-line treatment in the metastatic setting, he stated. In earlier stages of disease, the presence of these mutations may also influence decisions regarding adjuvant therapy post-surgery, including whether to administer targeted agents like EGFR or ALK inhibitors, he explained. Additionally, identifying these mutations is crucial because immunotherapy is generally contraindicated or less effective in patients harboring certain driver mutations, according to Ganti. Thus, molecular profiling at diagnosis is critical to optimize treatment selection, he summarized.

The Oncomine Dx Express Test includes a comprehensive panel that detects all clinically actionable mutations that have approved targeted therapies, Ganti highlighted. However, this assay does not encompass every biomarker under investigation, he noted. For example, alterations like 

 deletions are not tested for with this assay, and thus, patients with NSCLC may require additional or alternative testing to determine eligibility for certain ongoing clinical trials, he said. Nevertheless, the Oncomine Dx Express Test panel is considered sufficiently inclusive for guiding therapy with currently FDA-approved agents, he concluded.

Videos

Apar Kishor Ganti, MD, discusses the importance of molecular testing in NSCLC and the profiling capabilities of the Oncomine DX Express Test.

Apar Kishor Ganti, MD, professor of internal medicine, Division of Oncology/Hematology, University of Nebraska Medical Center, discusses lung cancer abstracts that were presented at the 2018 ASCO Annual Meeting.

KEYNOTE-189 and IMpower150 received a lot of attention at the 2018 ASCO Annual Meeting, explains Ganti. KEYNOTE-189 showed for the first time that adding pembrolizumab (Keytruda) to chemotherapy was superior to single-agent pembrolizumab in patients with advanced nonsquamous, non—small cell lung cancer (NSCLC).

These patients did not have a driver mutation in 

, says Ganti. The study enrolled treatment-naïve patients with stage IV lung cancer and randomized them to either carboplatin and pemetrexed (Alimta) or carboplatin, pemetrexed, and pembrolizumab. Regardless of PD-L1 status, Ganti says that the addition of pembrolizumab improved overall survival (OS) compared to carboplatin and pemetrexed.

IMpower150 looked at patients with advanced nonsquamous NSCLC. Standard carboplatin, paclitaxel, and bevacizumab (Avastin) was given with or without atezolizumab (Tecentriq). There seemed to be a benefit in OS with the addition of atezolizumab to the triplet backbone, states Ganti.

Apar Kishor Ganti, MD

Articles

FDA Approval Insights: Oncomine DX Express Test Companion Diagnostic for Sunvozertinib in Non–Small Cell Lung Cancer: With Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP

Dr Ganti on the Importance of Molecular Testing in NSCLC

Dr. Ganti on Lung Cancer Abstracts From the 2018 ASCO Annual Meeting