Randomized (TASTE) Trial In Early Stage Non-Small Cell Lung Cancer Trial, Demonstrates That GPS Proteomics Analysis Could Predict Tumor Response To A Platinum/Pemetrexed Chemotherapy Regimen While Standard Immunohistochemistry Test Fails To Do So

December 06, 2016

CULVER CITY, Calif.–(BUSINESS WIRE)–NantHealth and NantOmics, a leading molecular diagnostic company and a member of the NantWorks ecosystem of companies, today announced that the Company will present data on the positive predictive value of GPS Cancer quantitative proteomic analysis of ERCC1, a biomarker of chemotherapy resistance, in non-small cell lung cancer at the 17th World Conference on Lung Cancer in Vienna, Austria.

In this study, the NantOmics team, in collaboration with physician-scientists at the Institut Gustav Roussy in Paris, reanalyzed the French thoracic intergroup trial IFCT0801, named TASTE (Tailored Post-Surgical Therapy) in early stage non-small cell lung cancer trial, to identify proteomic biomarkers which could predict tumor response to a platinum/pemetrexed chemotherapy regimen. Previous biomarker analysis of this study reported in New England Journal of Medicine, using the standard diagnostic immunohistochemistry (IHC) test, failed to demonstrate a predictive role for ERCC1 in platinum resistance because the antibodies used could not specifically identify ERCC1 expression in tissue (NEJM 368(12):1101-10).

Using GPS cancer’s mass spectrometric based, quantitative, targeted proteomics assay, in this current study, the team specifically measured biomarkers thought to play a role in tumor response to platinum (ERCC1) and pemetrexed (thymidylate synthase and folate receptor alpha) and showed that each biomarker, when assayed using this quantitative proteomic method, indeed plays an important role in defining the tumors that could derive a benefit from each chemo regimen.

In commenting on the TASTE (Tailored Post-Surgical Therapy) in early stage non-small cell lung cancer trial, to identify proteomic biomarkers which could predict tumor response to a platinum/pemetrexed chemotherapy regimen.

Commenting on these results, Patrick Soon-Shiong, MD, NantHealth and NantOmics Chairman and CEO said the following: “This study provides clear and compelling evidence of the benefit of quantitative proteomics to identify NSCLC patients who will benefit from platinum-based therapy. Multiplexed quantitative proteomics is a powerful tool enabling the quantitation of ERCC1 simultaneously with multiple clinically relevant proteins in lung tumors and small biopsies providing the clinician with a potentially more accurate method to select patients who will respond to platinum-based therapies. Furthermore this prospectively designed retrospectively analyzed trial is the first to demonstrate the inaccuracies of the standard IHC test used today, a qualitative test developed in the 1940s. Quantitative proteomics enabled by GPS cancer brings the most complete molecular profiling of tumor tissue to the 21st century and will play an important role in informing physicians and patients as to the sensitivity or resistance to chemotherapy before treatment begins. We anticipate this knowledge of targeted chemotherapy could avoid toxicities by not administering chemotherapeutic agents known to be resistant before therapy begins.”

Lead Presenter, Jean-Charles Soria, MD, PhD, Chair, Drug Development Department, Institut Gustave Roussy, Paris, France, commented: “By using quantitative mass spectrometry, we may have unlocked an open issue regarding the possibility to accurately measure ERCC1, a key-player in defining platinum efficacy. Unlike previous studies of ERCC1, where IHC failed to identify patients who would benefit from therapy, the use of multiplexed targeted proteomics, has identified exact quantitative cutoffs in patients. This has allowed us to identify patients more likely to benefit from platinum based chemotherapy. An independent confirmatory adjuvant series is now needed.”

Todd Hembrough, PhD, President, Proteomics of NantOmics added, “Multiplexed, quantitative proteomics is the next leap forward in identifying and understanding the biology of a cancer, and NantOmics is at the forefront the clinical proteomics revolution, with a CAP/CLIA proteomics laboratory to analyze patient tissue, and help physicians understand their patients’ tumor biology.”

Presentation Summary

Proteomic Analysis of ERCC1 Predicts Benefit of Platinum Therapy in NSCLC: A Reevaluation of Samples from the TASTE Trial

· Abstract #OA06.05, http://library.iaslc.org/virtual-library-search?product_id=6&author=&category=&date=&session_type=&session=&presentation=&keyword=ercc1

· Presenter: Jean-Charles Soria, MD, Chair, Drug Development Department, Institut Gustave Roussy, Paris, France

· Monday, December 5, 2016

This presentation will review the potential use of mass spectrometry-based proteomics to quantitate ERCC1 protein in patients with NSCLC treated with platinum-based therapy in comparison to immunohistochemical-based methods.

About GPS Cancer™

GPS Cancer™ is a comprehensive molecular profile available through NantHealth. GPS Cancer integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, providing oncologists with unprecedented insight into the molecular signature of each patient’s cancer to inform personalized treatment strategies. GPS Cancer profiling is conducted in CLIA-certified and CAP-accredited laboratories, and is a key enabler for Cancer Breakthroughs 2020, the world’s most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. For more information, visit www.gpscancer.com and www.cancerbreakthroughs2020.org.

About NantHealth

NantHealth, Inc., a member of the NantWorks ecosystem of companies, is a next-generation, evidence-based, personalized healthcare company enabling improved patient outcomes and more effective treatment decisions for critical illnesses. NantHealth’s unique systems-based approach to personalized healthcare applies novel diagnostics tailored to the specific molecular profiles of patient tissues and integrates this molecular data in a clinical setting with large-scale, real-time biometric signal and phenotypic data to track patient outcomes and deliver precision medicine. For nearly a decade, NantHealth has developed an adaptive learning system, CLINICS, which includes its unique software, middleware and hardware systems infrastructure that collects, indexes, analyzes and interprets billions of molecular, clinical, operational and financial data points derived from novel and traditional sources, continuously improves decision-making and further optimizes our clinical pathways and decision algorithms over time. For more information, please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.

About NantOmics

NantOmics, a member of the NantWorks ecosystem of companies, delivers molecular diagnostic capabilities with the intent of providing actionable intelligence and molecularly driven decision support for cancer patients and their providers at the point of care. NantOmics is the first molecular diagnostics company to pioneer an integrated approach to unearthing the genomic and proteomic variances that initiate and drive cancer, by analyzing both normal and tumor cells from the same patient and following identified variances through from DNA to RNA to protein to drug. NantOmics has a highly scalable cloud-based infrastructure capable of storing and processing thousands of genomes a day, computing genomic variances in near real-time, and correlating proteomic pathway analysis with quantitative multi-plexed protein expression analysis from the same micro-dissected tumor sample used for genomic analysis. For more information, please visit www.nantomics.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.



Jen Hodson, 562-397-3639